Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards

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GSR Part 3 Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards 1. Introduction

You may also see all other General Safety Requirements, GSR Part 1 (Rev. 1), GSR Part 2, GSR Part 4 (Rev. 1), GSR Part 5, GSR Part 6 and GSR Part 7 and the Specific Safety Requirements for specific Facilities and Activities, SSR-2/1 (Rev. 1), SSR-2/2 (Rev. 1), SSR-3, SSR-4, SSR-5 and SSR-6 (Rev. 2).

Relevant Safety guides:

GSG-7 Occupational Radiation Protection

GSG-17 Application of the Concept of Exemption

GSG-18 Application of the Concept of Clearance

SSG-44 Establishing the Infrastructure for Radiation Safety

SSG-46 Radiological Protection and Safety in Medical Uses of Ionizing Radiation

GSG-8 Radiation Protection of the Public and the Environment

GSG-10 Prospective Radiological Environmental Impact Assessment for Facilities and Activities

GSG-19 Monitoring for Protection of the Public and the Environment

RS-G-1.9 Categorization of Radioactive Sources

SSG-19 National Strategy for Regaining Control over Orphan Sources and Improving Control over Vulnerable Sources

SSG-17 Control of Orphan Sources and Other Radioactive Material in the Metal Recycling and Production Industries

SSG-8 Radiation Safety of Gamma, Electron and X ray Irradiation Facilities

GSG-9 Regulatory Control of Radioactive Discharges to the Environment

SSG-11 Radiation Safety in Industrial Radiography

SSG-32 Protection of the Public against Exposure Indoors due to Radon and Other Natural Sources of Radiation

SSG-55 Radiation Safety of X Ray Generators and Other Radiation Sources Used for Inspection Purposes and for Non-medical Human Imaging

SSG-57 Radiation Safety in Well Logging

SSG-58 Radiation Safety in the Use of Nuclear Gauges

SSG-59 Radiation Safety of Accelerator Based Radioisotope Production Facilities

GSG-5 Justification of Practices, Including Non-Medical Human Imaging

SSG-36 Radiation Safety for Consumer Products

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-90 Radiation Protection Aspects of Design for Nuclear Power Plants

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors

GS-G-2.1 Arrangements for Preparedness for a Nuclear or Radiological Emergency

GSG-2 Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency

GSG-11 Arrangements for the Termination of a Nuclear or Radiological Emergency

GSG-15 Remediation Strategy and Process for Areas Affected by Past Activities or Events

See also:

IAEA e-learning course on Safety Standards Series No. GSR Part 3 Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards
Background
1.1. This General Safety Requirements publication, IAEA Safety Standards Series No. GSR Part 3, RadiationProtection and Safety of Radiation Sources: International Basic Safety Standards (hereinafter referred to as ‘these Standards’), is issued in the IAEA Safety Standards Series. It supersedes International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources issued in 1996 (the ‘BSS of 1996’)¹1. Section 1 does not include requir ements, but explains the context, concepts and principles for the requirements, which are established in Sections 2–5 and in the schedules.

1.2. Radioactivity is a natural phenomenon and natural sources of radiation are features of the environment. Radiation²2 and radioactive material may also be of artificial origin and they have many beneficial applications, including uses in medicine, industry, agriculture and research as well as for nuclear power generation. The radiation risks to people and the environment that may arise from the use of radiation and radioactive material must be assessed and must be controlled by means of the application of standards of safety³3.

1.3. Exposure of human tissues or organs to radiation can induce the death of cells on a scale that can be extensive enough to impair the function of the exposed tissue or organ. Effects of this type, which are called ‘deterministic effects’, are clinically observable in an individual only if the radiationdose exceeds a certain threshold level. Above this threshold level of dose, a deterministic effect is more severe for a higher dose.

1.4. Exposure to radiation can also induce the non-lethal transformation of cells, which may still retain their capacity for cell division. The human body’s immune system is very effective at detecting and destroying abnormal cells. However, there is a possibility that the non-lethal transformation of a cell could lead, after a latency period, to cancer in the individual exposed, if the cell is a somatic cell; or such a transformation of a cell could lead to hereditary effects, if the cell is a germ cell. Such effects are called ‘stochastic’ effects. For the purposes of these Standards, it is assumed that the probability of the eventual occurrence of a stochastic effect is proportional to the dose received, with no threshold. The ‘detriment-adjusted nominal risk coefficient of dose’, which includes the risks of all cancers and the risks of hereditary effects, is 5% per sievert [2]. This risk coefficient may need to be adjusted as new scientific knowledge becomes available.

1.5. The requirements established in these Standards are governed by the objectives, concepts and principles of the Fundamental Safety Principles [1]. These Standards draw upon information derived from the experience of States in applying the requirements of the BSS of 1996⁴4, and from experience in many States in the use of radiation and nuclear techniques. These Standards draw upon extensive research and development work by national and international scientific and engineering organizations on the health effects of radiationexposure and on measures and techniques for the safe design and use of radiation sources. These Standards also take account of the findings of the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) [3] and the Recommendations of the International Commission on Radiological Protection (ICRP) [2]. As scientific considerations are only part of the basis for making decisions on protection and safety, these Standards also address the use of value judgements relating to the management of risks.
The system of protection and safety
1.6. As stated in the Fundamental Safety Principles [1], “The fundamental safety objective is to protect people and the environment from harmful effects of ionizing radiation.” This objective must be achieved without unduly limiting the operation of facilities or the conduct of activities that give rise to radiation risks⁵5. Therefore, the system of protection and safety aims to assess, manage and controlexposure to radiation so that radiation risks, including risks of health effects and risks to the environment, are reduced to the extent reasonably achievable.

1.7. These Standards are based on the following safety principles stated in the Fundamental Safety Principles [1]:

Principle 1: Responsibility for safety

The prime responsibility for safety must rest with the person or organization responsible for facilities and activities that give rise to radiation risks.

Principle 2: Role of government

An effective legal and governmental framework for safety, including an independent regulatory body, must be established and sustained.

Principle 3: Leadership and management for safety

Effective leadership and management for safety must be established and sustained in organizations concerned with, and facilities and activities that give rise to, radiation risks.

Principle 4: Justification of facilities and activities

Facilities and activities that give rise to radiation risks must yield an overall benefit.

Principle 5: Optimization of protection

Protection must be optimized to provide the highest level of safety that can reasonably be achieved.

Principle 6: Limitation of risks to individuals

Measures for controllingradiation risks must ensure that no individual bears an unacceptable risk of harm.

Principle 7: Protection of present and future generations

People and the environment, present and future, must be protected against radiation risks.

Principle 8: Prevention of accidents

All practical efforts must be made to prevent and mitigate nuclear or radiationaccidents.

Principle 9: Emergency preparedness and response

Arrangements must be made for emergency preparedness and response for nuclear or radiationincidents.

Principle 10: Protective actions to reduce existing or unregulated radiation risks

Protective actions to reduce existing or unregulated radiation risks must be justified and optimized.

The three general principles of radiation protection, which concern justification, optimization of protection and application of dose limits, are expressed in Safety Principles 4, 5, 6 and also 10 [1].

1.8. The prime responsibility for safety must rest with the person or organization responsible for facilities and activities⁶6 that give rise to radiation risks [1]. Other parties also bear certain responsibilities. For instance, suppliers of radiation generators and radioactive sources have responsibilities in relation to their design and manufacture and operating instructions for their safe use. In the case of medical exposures, because of the medical setting in which such exposures occur, primary responsibility for protection and safety for patients lies with the health professional responsible for administration of the radiation dose, who is referred to in these Standards as the ‘radiological medical practitioner’. Other types of health professional may be involved in the preparation for, and the conduct of, radiological procedures, and each type has specific responsibilities, as established in these Standards.

1.9. A properly established governmental, legal and regulatory framework for safety provides for the regulation of facilities and activities that give rise to radiation risks. There is a hierarchy of responsibilities within this framework, from governments to regulatory bodies to the organizations responsible for, and the persons engaged in, activities involving radiation exposure. The government is responsible for the adoption within its national legal system of such legislation, regulations, and standards and measures as may be necessary to fulfil all its national and international obligations effectively, and for the establishment of an independent regulatory body. In some cases, more than one governmental organization may have the functions of a regulatory body for activities within their jurisdictions relating to the control of radiation and radioactive material.

1.10. Both the government and the regulatory body have important responsibilities in establishing the regulatory framework for protecting people and the environment from harmful effects of radiation, including establishing standards. These Standards require the government to ensure that there is coordination of government departments and agencies that have responsibilities for protection and safety, including the regulatory body, and of departments and agencies concerned with public health, the environment, labour, mining, science and technology, agriculture and education. Standards have to be developed by means of consultation with those who are or who could be required to apply them.

1.11. The government is also responsible for ensuring, as necessary, that provision is made for support services, such as education and training, and technical services. If these services are not available within the State, other mechanisms to provide them may have to be considered. The regulatory body is responsible for carrying out its required regulatory functions, such as the establishment of requirements and guidelines, the authorization and inspection of facilities and activities, and the enforcement of legislative and regulatory provisions.

1.12. Leadership in safety matters has to be demonstrated at the highest levels in an organization, and safety has to be achieved and maintained by means of an effective management system. This system has to integrate all elements of management so that requirements for protection and safety are established and applied coherently with other requirements, including those for health, human performance, quality, protection of the environment and security, together with economic considerations. The application of the management system also has to ensure the promotion of safety culture, the regular assessment of safety performance and the application of lessons learned from experience. Safety culture includes individual and collective commitment to safety on the part of the leadership, the management and personnel at all levels. The term ‘management system’ reflects and includes the concept of ‘quality control’ (controlling the quality of products) and its evolution through ‘quality assurance’ (the system for ensuring the quality of products) and ‘quality management system’ (the system for managing quality).

1.13. The operation of facilities or the conduct of activities that introduce a new source of radiation, that change exposures or that change the likelihood of exposures has to be justified in the sense that the detriments that may be caused are outweighed by the individual and societal benefits that are expected. The comparison of detriments and benefits often goes beyond the consideration of protection and safety, and involves the consideration of economic, societal and environmental factors also.

1.14. The application of the justification principle to medical exposures requires a special approach. As an overarching justification of medical exposures, it is accepted that the use of radiation in medicine does more good than harm. However, at the next level, there is a need for generic justification, to be carried out by the health authority in conjunction with appropriate professional bodies, of a given radiological procedure. This applies to the justification of new technologies and techniques as they evolve. For the final level of justification, the application of the radiological procedure to a given individual has to be considered. The specific objectives of the exposure, the clinical circumstances and the characteristics of the individual involved have to be taken into account by means of referral guidelines developed by professional bodies and the health authority.

1.15. The optimization of protection and safety, when applied to the exposure of workers and members of the public, and carers and comforters of patients undergoing radiological procedures, is a process for ensuring that the likelihood and magnitude of exposures and the number of individuals exposed are as low as reasonably achievable, with economic, societal and environmental factors taken into account. This means that the level of protection would be the best possible under the prevailing circumstances. Optimization is a prospective and iterative process that requires both qualitative and quantitative judgements to be made.

1.16. As is the case with justification, the application of the optimization principle to the medical exposure of patients, and to that of volunteers as part of a programme of biomedical research, requires a special approach. Too low a radiationdose could be as bad as too high a radiationdose, in that the consequence could be that a cancer is not cured or the images obtained are not of suitable diagnostic quality. It is of paramount importance that the medical exposure leads to the required outcome.

1.17. For planned exposure situations, exposures and risks are subject to control to ensure that the specified dose limits for occupational exposure and those for public exposure are not exceeded, and optimization is applied to attain the desired level of protection and safety.

1.18. All practical efforts must be made to prevent and mitigate nuclear or radiological accidents. The most harmful consequences arising from facilities and activities have come from the loss of control over a nuclear reactor core, nuclear chain reaction, radioactive source or other source of radiation. Consequently, to ensure that the likelihood of an accident having harmful consequences is extremely low, measures have to be taken:

To prevent the occurrence of failures or abnormal conditions (including breaches of security) that could lead to such a loss of control;

To prevent the escalation of any such failures or abnormal conditions that do occur;

To prevent the loss of, or the loss of control over, a radioactive source or other source of radiation.

1.19. Arrangements must be made for emergency preparedness and response for nuclear or radiological incidents. The primary goals of preparedness and response for a nuclear or radiological emergency are:

To ensure that arrangements are in place for an effective response at the scene and, as appropriate, at the local, regional, national and international levels, to a nuclear or radiationemergency;

To ensure that, for reasonably foreseeable incidents, radiation risks would be minor;

For any incidents that do occur, to take practical measures to mitigate any consequences for human life and health and the environment.

Types of exposure situation
1.20. For the purpose of establishing practical requirements for protection and safety, these Standards distinguish between three different types of exposure situation: planned exposure situations, emergency exposure situations and existing exposure situations [2]. Together, these three types of exposure situation cover all situations of exposure for which these Standards apply:

A planned exposure situation is a situation of exposure that arises from the planned operation of a source or from a planned activity that results in an exposure due to a source. Since provision for protection and safety can be made before embarking on the activity concerned, the associated exposures and their likelihood of occurrence can be restricted from the outset. The primary means of controllingexposure in planned exposure situations is by good design of facilities, equipment and operating procedures, and by training. In planned exposure situations, exposure at some level can be expected to occur. If exposure is not expected to occur with certainty, but could result from an accident or from an event or a sequence of events that may occur but is not certain to occur, this is referred to as ‘potential exposure’.

An emergency exposure situation is a situation of exposure that arises as a result of an accident, a malicious act or any other unexpected event, and requires prompt action in order to avoid or to reduce adverse consequences. Preventive measures and mitigatory actions have to be considered before an emergency exposure situation arises. However, once an emergency exposure situation actually arises, exposures can be reduced only by implementing protective actions.

An existing exposure situation is a situation of exposure that already exists when a decision on the need for control needs to be taken. Existing exposure situations include situations of exposure to natural backgroundradiation. They also include situations of exposure due to residual radioactive material that derives from past practices that were not subject to regulatory control or that remains after an emergency exposure situation.

If an event or a sequence of events that has been considered in the assessment of potential exposure does actually occur, it may be treated either as a planned exposure situation or, if an emergency has been declared, as an emergency exposure situation.

1.21. The descriptions that are given in para. 1.20 of the three types of exposure situation are not always sufficient to determine unequivocally which type of exposure situation applies for particular circumstances. For instance, the transitions from an emergency exposure situation to an existing exposure situation may occur progressively over time; and some exposures due to natural sources may have some characteristics of both planned exposure situations and existing exposure situations. In these Standards, the most appropriate type of exposure situation for particular circumstances has been determined by taking practical considerations into account. For the purposes of these Standards, the exposure of aircrew to cosmic radiation is considered under existing exposure situations in Section 5. The exposure of space crew to cosmic radiation presents exceptional circumstances and these are considered separately in Section 5.
Dose constraints and reference levels
1.22. Dose constraints and reference levels are used for optimization of protection and safety, the intended outcome of which is that all exposures are controlled to levels that are as low as reasonably achievable, economic, societal and environmental factors being taken into account. Dose constraints are applied to occupational exposure and to public exposure in planned exposure situations. Dose constraints are set separately for each source under control and they serve as boundary conditions in defining the range of options for the purposes of optimization of protection and safety. Dose constraints are not dose limits exceeding a dose constraint does not represent non-compliance with regulatory requirements, but it could result in follow-up actions.

1.23. While the objectives of the use of dose constraints for controllingoccupational exposure and public exposure are similar, the dose constraints are applied in different ways. For occupational exposure, the dose constraint is a tool to be established and used in the optimization of protection and safety by the person or organization responsible for a facility or an activity. For public exposure in planned exposure situations, the government or the regulatory body ensures the establishment or approval of dose constraints, taking into account the characteristics of the site and of the facility or activity, the scenarios for exposure and the views of interested parties. After exposures have occurred, the dose constraint may be used as a benchmark for assessing the suitability of the optimized strategy for protection and safety (referred to as the protection strategy) that has been implemented and for making adjustments as necessary. The setting of the dose constraint needs to be considered in conjunction with other health and safety provisions and the technology available.

1.24. Reference levels are used for optimization of protection and safety in emergency exposure situations and in existing exposure situations. They are established or approved by the government, the regulatory body or another relevant authority. For occupational exposure and public exposure in emergency exposure situations and in existing exposure situations, a reference level serves as a boundary condition in identifying the range of options for the purposes of optimization in implementing protective actions. The reference level represents the level of dose or the level of risk above which it is judged to be inappropriate to plan to allow exposures to occur, and below which the optimization of protection and safety is implemented. The value chosen for the reference level will depend on the prevailing circumstances for the exposures under consideration. The optimized protection strategies are intended to keep doses below the reference level. When an emergency exposure situation has arisen or an existing exposure situation has been identified, actual exposures could be above or below the reference level. The reference level would be used as a benchmark for judging whether further protective actions are necessary and, if so, in prioritizing their application. Optimization of protection and safety is to be applied in emergency exposure situations and in existing exposure situations, even if the doses initially received are below the reference level.

1.25. The ICRP recommends a range of doses spanning two orders of magnitude within which the value of a dose constraint or reference level would usually be chosen [2]. At the lower end of this range, the dose constraint or reference level represents an increase, of up to about 1 mSv, over the dose received in a year from exposure due to naturally occurring radiation sources⁷7. It would be used when individuals are exposed to radiation from a source that yields little or no benefit for them, but which may benefit society in general. This would be the case, for instance, in establishing dose constraints for public exposure in planned exposure situations.

1.26. Dose constraints or reference levels of 1–20 mSv would be used when the exposure situation — but not necessarily the exposure itself — usually benefits individuals. This would be the case, for instance, when establishing dose constraints for occupational exposure in planned exposure situations or reference levels for exposure of a member of the public in existing exposure situations.

1.27. Reference levels of 20–100 mSv would be used where individuals are exposed to radiation from sources that are not under control or where actions to reduce doses would be disproportionately disruptive. This would be the case, for instance, in establishing reference levels for the residual dose after a nuclear or radiological emergency. Any situation that resulted in a dose of greater than 100 mSv being incurred within a short period of time or in one year would be considered unacceptable, except under the circumstances relating to exposure of emergency workers that are addressed specifically in these Standards.

1.28. The selection of the value for the dose constraint or the reference level would be based on the characteristics of the exposure situation, including:

The nature of the exposure and the practicability of reducing or preventing the exposure;

The expected benefits of the exposure for individuals and society, or the benefits of avoiding preventive measures or protective actions that would be detrimental to living conditions, as well as other societal criteria relating to the management of the exposure situation;

National or regional factors, together with a consideration of international guidance and good practice elsewhere.

1.29. The system of protection and safety required by these Standards includes criteria for protection against exposure due to radon that are based on the average level of risk to a population with typical but various smoking habits. Owing to the synergistic effects of smoking and exposure due to radon, the absolute risk of lung cancer resulting from unit dose from exposure due to radon for people who are smokers is substantially greater than for those who have never smoked [3, 5, 6]. Information provided to people on the risks associated with exposure due to radon needs to highlight this increased risk for smokers.

1.30. Dose constraints are used in optimization of protection and safety for carers and comforters and for volunteers subject to exposure as part of a programme of biomedical research. Dose constraints are not applicable to the exposure of patients in radiological procedures for the purposes of medical diagnosis or treatment.

1.31. In X ray medical imaging, image guided interventional procedures and diagnostic nuclear medicine, a diagnostic reference level is used to indicate the need for an investigation. Periodic assessments are performed of typical doses or activity of the radiopharmaceuticals administered in a medical facility. If comparison with established diagnostic reference levels shows that the typical doses or activity of the radiopharmaceuticals administered are either too high or unusually low, a local review is to be initiated to ascertain whether protection and safety has been optimized and whether any corrective action is required.
Protection of the environment
1.32. In a global and long term perspective, protection of people and the environment against radiation risks associated with the operation of facilities and the conduct of activities — and in particular, protection against such risks that may transcend national borders and may persist for long periods of time — is important for achieving equitable and sustainable development.

1.33. The system of protection and safety required by these Standards generally provides for appropriate protection of the environment from harmful effects of radiation. Nevertheless, international trends in this field show an increasing awareness of the vulnerability of the environment. Trends also indicate the need to be able to demonstrate (rather than to assume) that the environment is being protected against effects of industrial pollutants, including radionuclides, in a wider range of environmental situations, irrespective of any human connection. This is usually accomplished by means of a prospective environmental assessment to identify impacts on the environment, to define the appropriate criteria for protection of the environment, to assess the impacts and to compare the expected results of the available options for protection. Methods and criteria for such assessments are being developed and will continue to evolve.

1.34. Radiological impacts in a particular environment constitute only one type of impact and, in most cases, may not be the dominant impacts of a particular facility or activity. Furthermore, the assessment of impacts on the environment needs to be viewed in an integrated manner with other features of the system of protection and safety to establish the requirements applicable to a particular source. Since there are complex interrelations, the approach to the protection of people and the environment is not limited to the prevention of radiological effects on humans and on other species. When establishing regulations, an integrated perspective has to be adopted to ensure the sustainability, now and in the future, of agriculture, forestry, fisheries and tourism, and of the use of natural resources. Such an integrated perspective also has to take into account the need to prevent unauthorized acts with potential consequences for and via the environment, including, for example, the illicit dumping of radioactive material and the abandonment of radiation sources. Consideration also needs to be given to the potential for buildup and accumulation of long lived radionuclides released to the environment.

1.35. These Standards are designed to identify the protection of the environment as an issue necessitating assessment, while allowing for flexibility in incorporating into decision making processes the results of environmental assessments that are commensurate with the radiation risks.

Relevant Safety Guides:

GSG-10 Prospective Radiological Environmental Impact Assessment for Facilities and Activities
Interfaces between safety and security
1.36. Safety measures and security measures have in common the aim of protecting human life and health and the environment. In addition, safety measures and security measures must be designed and implemented in an integrated manner, so that security measures do not compromise safety and safety measures do not compromise security.

1.37. Security infrastructure and safety infrastructure need to be developed, as far as possible, in a well coordinated manner. All the organizations involved need to be made aware of the commonalities and the differences between safety and security so as to be able to factor both into development plans. The synergies between safety and security have to be developed so that safety and security complement and enhance one another.
Objective
1.38. These Standards establish requirements for the protection of people and the environment from harmful effects of ionizing radiation and for the safety of radiation sources.
Scope
1.39. These Standards apply for protection against ionizing radiation only, which includes gamma rays, X rays and particles such as beta particles, neutrons, protons, alpha particles and heavier ions. While these Standards do not specifically address the control of non-radiological aspects of health, safety and the environment, these aspects also need to be considered. Protection from harmful effects of non-ionizing radiation is outside the scope of these Standards.

1.40. These Standards are intended primarily for use by governments and regulatory bodies. Requirements also apply to principal parties and other parties as specified in Section 2, health authorities, professional bodies and service providers such as technical support organizations.

1.41. These Standards do not deal with security measures. The IAEA issues recommendations on nuclear security in the IAEA Nuclear Security Series.

1.42. These Standards apply to all situations involving radiation exposure that is amenable to control. Exposures deemed to be not amenable to control are excluded from the scope of these Standards.⁸8

1.43. These Standards establish requirements to be fulfilled in all facilities and activities giving rise to radiation risks. For certain facilities and activities, such as nuclear installations, radioactive waste management facilities and the transport of radioactive material, other safety requirements, complementary to these Standards, also apply. The IAEA issues Safety Guides to assist in the application of these Standards.

1.44. These Standards apply to three categories of exposure: occupational exposure, public exposure and medical exposure.

1.45. These Standards apply to human activities involving radiation exposure that are:

Carried out in a State which decides to adopt these Standards or which requests any of the Sponsoring Organizations to provide for the application of these Standards;

Undertaken by States with the assistance of the Food and Agriculture Organization of the United Nations, the IAEA, the International Labour Organization, the Pan American Health Organization, the United Nations Environment Programme or the World Health Organization, in the light of relevant national rules and regulations;

Carried out by the IAEA or involving the use of materials, services, equipment, facilities and non-published information made available by the IAEA or at its request or under its control or supervision; or

Carried out under any bilateral or multilateral arrangement whereby the parties request the IAEA to provide for the application of these Standards.

1.46. Quantities and units used in these Standards are in accordance with the recommendations of the International Commission on Radiation Units and Measurements [7].
Structure
1.47. The requirements of these Standards are grouped into requirements applicable for all exposure situations and separate sets of requirements for planned exposure situations, emergency exposure situations and existing exposure situations. For each of the three types of exposure situation, the requirements are further grouped into requirements for occupational exposure, public exposure and (for planned exposure situations only) medical exposure.

1.48. The requirements established by these Standards, both numbered ‘overarching’ requirements in bold with titles and other requirements, are expressed as ‘shall’ statements. Each individual overarching requirement is followed by associated requirements.

1.49. Section 2 sets out the requirements that apply generally for all exposure situations and for all of the three categories of exposure (occupational exposure, public exposure and medical exposure). These requirements include the assignment of responsibilities to the government, the regulatory body, and principal parties and other parties with respect to the implementation of a protection and safety programme and a management system, the promotion of safety culture and the consideration of human factors.

1.50. Section 3 sets out the requirements — in addition to those of Section 2 — for planned exposure situations. Section 3 includes requirements applicable to all three categories of exposure, requirements for the safety of sources, and separate sets of requirements in respect of occupational exposure, public exposure and medical exposure.

1.51. Section 4 sets out the requirements — in addition to those of Section 2 — for emergency exposure situations. Section 4 includes requirements in respect of public exposure and occupational exposure (i.e. exposure of emergency workers) in emergency exposure situations. It also includes requirements on the transitions from an emergency exposure situation to an existing exposure situation.

1.52. Section 5 sets out the requirements — in addition to those of Section 2 — for existing exposure situations. Section 5 includes requirements in respect of public exposure and occupational exposure in existing exposure situations. It includes requirements in respect of remediation of sites and habitation in areas with residual radioactive material, radon in homes and in workplaces, radionuclides in commodities, and exposure of aircrew and of space crew.

1.53. The organization of the requirements in these Standards for the relevant categories of exposure in each type of exposure situation is as shown in Table 1. General requirements for all exposure situations are given in Section 2, and requirements for different exposure situations are given in Sections 3–5. Thus, for any particular facility or activity, more than one section of these Standards will be relevant, as illustrated by the following examples:

(a) The requirements for the regulatory body given in Section 2 are applicable for all exposure situations and all categories of exposure. They provide the regulatory framework within which persons or organizations responsible for facilities and activities have to comply with requirements placed on them. These requirements, thus, establish the general regulatory responsibilities of the regulatory body. Any further requirements on the regulatory body that apply for one type of exposure situation are given in Sections 3–5. These further requirements are in addition to the requirements given in Section 2.

TABLE 1. ORGANIZATION OF THE REQUIREMENTS OF THESE STANDARDS

Occupational exposure

Public exposure

Medical exposure

Planned exposure situations

Section 2;

Section 3: paras 3.5–3.67 and paras 3.68–3.116

Section 2;

Section 3: paras 3.5–3.67 and paras 3.117–3.144

Section 2;

Section 3: paras 3.5–3.67 and paras 3.145–3.185

Emergency exposure situations

Section 2;

Section 4

Section 2;

Section 4

Not applicable

Existing exposure situations

Section 2;

Section 5

Section 2;

Section 5

Not applicable

(b) Persons or organizations responsible for a medical facility in which radiation generators or radioactive sources are used are subject to the requirements given in Section 2 for all exposure situations and all categories of exposure, and also to those requirements given in Section 3 that are common to all planned exposure situations (paras 3.5–3.67). In addition, such persons or organizations are subject to the separate requirements given in Section 3 for occupational exposure (such as exposure of medical staff operating medical devices that emit radiation) (paras 3.68–3.116), public exposure (such as exposure in rooms adjacent to rooms containing equipment that generates radiation) (paras 3.117–3.144) and medical exposure (such as exposure of patients) (paras 3.145–3.185).

1.54. Schedules I–IV provide numerical values in support of the requirements, covering exemption and clearance, categorization of sealed sources, dose limits for planned exposure situations and criteria for use in emergency preparedness and response.

1.55. Definitions of terms used are included in these Standards.
2. General Requirements for Protection and Safety Definitions
2.1. Terms used have the meanings given under Definitions.
Interpretation
2.2. Except as specifically authorized by the statutory governing body of a Sponsoring Organization, no interpretation of these Standards by any officer or employee of the Sponsoring Organization other than a written interpretation by the Director General of the Sponsoring Organization will be binding on the Sponsoring Organization.
Resolution of Conflicts
2.3. The requirements of these Standards are in addition to and not in place of other applicable requirements, such as those of relevant binding conventions and national laws and regulations.

2.4. In cases of conflict between the requirements of these Standards and other applicable requirements, the government or the regulatory body, as appropriate, shall determine which requirements are to be enforced.

2.5. Nothing in these Standards shall be construed as restricting any actions that may otherwise be necessary for protection and safety or as relieving the parties referred to in paras 2.40 and 2.41 from complying with applicable laws and regulations.
Entry into Force
2.6. These Standards shall enter into force one year after the date of their adoption or acknowledgement, as appropriate, by the Sponsoring Organization.

2.7. If a State decides to adopt these Standards, these Standards shall come into force at the time indicated in the formal adoption by that State.
Application of the Principles of Radiation Protection Requirement 1: Application of the principles of radiation protection
Parties with responsibilities for protection and safety shall ensure that the principles of radiation protection are applied for all exposure situations.

2.8. For planned exposure situations, each party with responsibilities for protection and safety shall ensure, when relevant requirements apply to that party, that no practice is undertaken unless it is justified.

2.9. For emergency exposure situations and existing exposure situations, each party with responsibilities for protection and safety shall ensure, when relevant requirements apply to that party, that protective actions or remedial actions are justified and are undertaken in such a way as to achieve the objectives set out in a protection strategy.

2.10. For all exposure situations, each party with responsibilities for protection and safety shall ensure, when relevant requirements apply to that party, that protection and safety is optimized⁹9.

2.11. For planned exposure situations other than for medical exposure, each party with responsibilities for protection and safety shall ensure that, when relevant requirements apply to that party, specified dose limits are not exceeded.

2.12. The application of the requirements for the system of protection and safety shall be commensurate with the radiation risks associated with the exposure situation.

Relevant Safety guides:

GSG-13 Functions and Processes of the Regulatory Body for Safety

GSG-7 Occupational Radiation Protection

GSG-17 Application of the Concept of Exemption

GSG-18 Application of the Concept of Clearance

GSG-19 Monitoring for Protection of the Public and the Environment

SSG-32 Protection of the Public against Exposure Indoors due to Radon and Other Natural Sources of Radiation

GSG-5 Justification of Practices, Including Non-Medical Human Imaging

GSG-9 Regulatory Control of Radioactive Discharges to the Environment

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-90 Radiation Protection Aspects of Design for Nuclear Power Plants

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors

GS-G-2.1 Arrangements for Preparedness for a Nuclear or Radiological Emergency

GSG-2 Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency

GSG-15 Remediation Strategy and Process for Areas Affected by Past Activities or Events

GSG-10 Prospective Radiological Environmental Impact Assessment for Facilities and Activities

SSG-44 Establishing the Infrastructure for Radiation Safety
Responsibilities of the Government
¹⁰ 10
Requirement 2: Establishment of a legal and regulatory framework
The government shall establish and maintain a legal and regulatory framework for protection and safety and shall establish an effectively independent regulatory body with specified responsibilities and functions.

2.13. The government shall establish and maintain an appropriate and effective legal and regulatory framework for protection and safety in all exposure situations.¹¹11 This framework shall encompass both the assignment and the discharge of governmental responsibilities, and the regulatory control of facilities and activities that give rise to radiation risks. The framework shall allow for the fulfilment of international obligations.

2.14. The government shall ensure that adequate arrangements are in place for the protection of people and the environment, both now and in the future, against harmful effects of ionizing radiation, without unduly limiting the operation of facilities or the conduct of activities that give rise to radiation risks. This shall include arrangements for the protection of people of present and future generations and populations remote from present facilities and activities.

2.15. The government shall establish legislation that, among other things:

Provides the statutory basis for requirements for protection and safety for all exposure situations;

Specifies that the prime responsibility for protection and safety rests with the person or organization responsible for facilities and activities that give rise to radiation risks;

Specifies the scope of its applicability;

Establishes and provides for maintaining an independent regulatory body with clearly specified functions and responsibilities for the regulation of protection and safety;

Provides for coordination between authorities with responsibilities relevant to protection and safety for all exposure situations.

2.16. The government shall ensure that the regulatory body is effectively independent, in making decisions relating to protection and safety, of persons and organizations using or promoting the use of radiation and radioactive material, so that it is free from any undue influence by interested parties and from any conflicts of interest; and shall ensure that it has functional separation from entities having responsibilities or interests that could unduly influence its decision making.

2.17. The government shall ensure that the regulatory body has the legal authority, competence and resources necessary to fulfil its statutory functions and responsibilities.

2.18. The government shall ensure that a graded approach is taken to the regulatory control of radiation exposure, so that the application of regulatory requirements is commensurate with the radiation risks associated with the exposure situation.

2.19. The government shall establish mechanisms to ensure that:

The activities of the regulatory body are coordinated with those of other governmental authorities, in accordance with para. 2.15(e), and with national and international organizations that have related responsibilities;

Interested parties are involved as appropriate in regulatory decision making processes or regulatory decision aiding processes.

2.20. The government shall ensure that arrangements are in place at the national level for making decisions relating to protection and safety that fall outside the authority of the regulatory body.

2.21. The government shall ensure that requirements are established for:

Education, training, qualification and competence in protection and safety of all persons engaged in activities relevant to protection and safety;

The formal recognition¹²12 of qualified experts;

The competence of organizations that have responsibilities relating to protection and safety.

2.22. The government shall ensure that arrangements are in place for the provision of the education and training services required for building and maintaining the competence of persons and organizations that have responsibilities relating to protection and safety.

See also:

Safety Report Series No. 93, 'A Methodology for Establishing a National Strategy for Education and Training in Radiation, Transport and Waste Safety'

2.23. The government shall ensure that arrangements are in place for the provision of technical services relating to protection and safety, such as services for personal dosimetry, environmental monitoring and the calibration of monitoring and measuring equipment.

2.24. The government shall ensure that arrangements are in place for the safe decommissioning of facilities [9], the safe management of radioactive waste [10, 11] and the safe management of spent fuel.

2.25. The government shall ensure that the transport of radioactive material is in accordance with the IAEA Regulations for the Safe Transport of Radioactive Material (the IAEA Transport Regulations) [12] and with any applicable international conventions, taking into consideration other internationally endorsed standards and recommendations derived from the IAEA Transport Regulations.¹³13

2.26. The government shall ensure that arrangements are in place for regaining control over radioactive sources that have been abandoned, lost, misplaced, stolen or otherwise transferred without proper authorization.

2.27. The government shall ensure that infrastructural arrangements are in place for the interfaces between safety and the security of radioactive sources.

2.28. In establishing the legal and regulatory framework for protection and safety, the government:

Shall fulfil its respective international obligations;

Shall allow for participation in relevant international arrangements, including international peer reviews;

Shall promote international cooperation to enhance safety globally.

See alsoGSR Part 1 (Rev. 1), Governmental, Legal and Regulatory Framework for Safety:

Relevant Safety guides:

GSG-19 Monitoring for Protection of the Public and the Environment

SSG-17 Control of Orphan Sources and Other Radioactive Material in the Metal Recycling and Production Industries

SSG-19 National Strategy for Regaining Control over Orphan Sources and Improving Control over Vulnerable Sources

SSG-8 Radiation Safety of Gamma, Electron and X ray Irradiation Facilities

SSG-11 Radiation Safety in Industrial Radiography

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

GSG-10 Prospective Radiological Environmental Impact Assessment for Facilities and Activities

SSG-44 Establishing the Infrastructure for Radiation Safety
Responsibilities of the Regulatory Body Requirement 3: Responsibilities of the regulatory body
The regulatory body shall establish or adopt regulations and guides for protection and safety and shall establish a system to ensure their implementation.

2.29. The regulatory body shall establish requirements for the application of the principles of radiation protection specified in paras 2.8–2.12 for all exposure situations and shall establish or adopt regulations and guides for protection and safety.

2.30. The regulatory body shall establish a regulatory system for protection and safety that includes [8]:

Notification and authorization;

Review and assessment of facilities and activities;

Inspection of facilities and activities;

Enforcement of regulatory requirements;

The regulatory functions relevant to emergency exposure situations and existing exposure situations;

Provision of information to, and consultation with, parties affected by its decisions and, as appropriate, the public and other interested parties.

2.31. The regulatory body shall adopt a graded approach to the implementation of the system of protection and safety, such that the application of regulatory requirements is commensurate with the radiation risks associated with the exposure situation.

2.32. The regulatory body shall ensure the application of the requirements for education, training, qualification and competence in protection and safety of all persons engaged in activities relevant to protection and safety.

2.33. The regulatory body shall ensure that mechanisms are in place for the timely dissemination of information to relevant parties, such as suppliers of and users of sources, on lessons learned for protection and safety from regulatory experience and operating experience, and from incidents and accidents and the related findings. The mechanisms established shall, as appropriate, be used to provide relevant information to other relevant organizations at the national and international level.

2.34. The regulatory body, in conjunction with other relevant authorities, shall specify requirements for acceptance and for performance, by regulation or by the application of published standards, for any manufactured or constructed source, device, equipment or facility that, when in use, has implications for protection and safety.

2.35. The regulatory body shall make provision for establishing, maintaining and retrieving adequate records relating to facilities and activities. These records shall include:

Registers of sealed sources and radiation generators¹⁴14;

Records of doses from occupational exposure;

Records relating to the safety of facilities and activities;

Records that might be necessary for the shutdown and decommissioning or closure of facilities;

Records of events, including non-routine releases of radioactive material to the environment;

Inventories of radioactive waste and of spent fuel.

2.36. The regulatory body shall establish mechanisms for communication and discussion that involve professional and constructive interactions with relevant parties for all protection and safety related issues.

2.37. The regulatory body, in consultation with the health authority, shall ensure that provisions are in place for ensuring protection and safety in the handling of deceased persons or human remains that are known to contain sealed or unsealed radioactive sources, either as a result of radiological procedures for medical treatment of patients or as a consequence of an emergency.

2.38. The regulatory body shall establish, implement, assess and strive to continually improve a management system that is aligned with the goals of the regulatory body and that contributes to the achievement of those goals.

Relevant Safety guides:

GSG-12 Organization, Management and Staffing of the Regulatory Body for Safety

GSG-13 Functions and Processes of the Regulatory Body for Safety

GSG-6 Communication and Consultation with Interested Parties by the Regulatory Body

SSG-8 Radiation Safety of Gamma, Electron and X ray Irradiation Facilities

SSG-11 Radiation Safety in Industrial Radiography

GSG-9 Regulatory Control of Radioactive Discharges to the Environment

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education
Responsibilities for Protection and Safety Requirement 4: Responsibilities for Protection and Safety
The person or organization responsible for facilities and activities that give rise to radiation risks shall have the prime responsibility for protection and safety. Other parties shall have specified responsibilities for protection and safety.

2.39. The person or organization responsible for any facility or activity that gives rise to radiation risks shall have the prime responsibility for protection and safety, which cannot be delegated.

2.40. The principal parties responsible for protection and safety are:

Registrants or licensees, or the person or organization responsible for facilities and activities for which notification only is required;

Employers, in relation to occupational exposure;

Radiological medical practitioners, in relation to medical exposure;

Those persons or organizations designated to deal with emergency exposure situations or existing exposure situations.

2.41. Other parties shall have specified responsibilities in relation to protection and safety. These other parties include:

Suppliers of sources, providers of equipment and software, and providers of consumer products;

Radiation protection officers;

Referring medical practitioners;

Medical physicists;

Medical radiation technologists;

Qualified experts or any other party to whom a principal party has assigned specific responsibilities;

Workers other than workers listed in (a)–(f) in this paragraph;

Ethics committees.

2.42. The relevant principal parties shall establish and implement a protection and safety programme that is appropriate for the exposure situation. The protection and safety programme:

Shall adopt objectives for protection and safety in accordance with the requirements of these Standards;

Shall apply measures for protection and safety that are commensurate with the radiation risks associated with the exposure situation and that are adequate to ensure compliance with the requirements of these Standards.

2.43. The relevant principal parties shall ensure that, in the implementation of the protection and safety programme:

The measures and resources that are necessary for achieving the objectives for protection and safety have been determined and are duly provided;

The programme is periodically reviewed to assess its effectiveness and its continued fitness for purpose;

Any failures or shortcomings in protection and safety are identified and corrected, and steps are taken to prevent their recurrence;

Arrangements are made to consult with interested parties;

Appropriate records are maintained.

2.44. The relevant principal parties and other parties having specified responsibilities in relation to protection and safety shall ensure that all personnel engaged in activities relevant to protection and safety have appropriate education, training and qualification so that they understand their responsibilities and can perform their duties competently, with appropriate judgement and in accordance with procedures.

2.45. The relevant principal parties shall permit access by authorized representatives of the regulatory body to carry out inspections of their facilities and activities and of their protection and safety records, and shall cooperate in the conduct of inspections.

2.46. The relevant principal parties shall ensure that qualified experts are identified and are consulted as necessary on the proper observance of these Standards.

Relevant Safety guides:

SSG-8 Radiation Safety of Gamma, Electron and X ray Irradiation Facilities

SSG-11 Radiation Safety in Industrial Radiography

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors
Management Requirements Requirement 5: Management for protection and safety
The principal parties shall ensure that protection and safety are effectively integrated into the overall management system of the organizations for which they are responsible.

.
Protection and safety elements of the management system
2.47. The principal parties shall demonstrate commitment to protection and safety at the highest levels within the organizations for which they are responsible.

2.48. The principal parties shall ensure that the management system¹⁵15 is designed and applied to enhance protection and safety by:

Applying the requirements for protection and safety coherently with other requirements, including requirements for operational performance, and coherently with guidelines for security;

Describing the planned and systematic actions necessary to provide adequate confidence that the requirements for protection and safety are fulfilled;

Ensuring that protection and safety are not compromised by other requirements;

Providing for the regular assessment of performance for protection and safety, and the application of lessons learned from experience;

Promoting safety culture.

2.49. The principal parties shall ensure that protection and safety elements of the management system are commensurate with the complexity of and the radiation risks associated with the activity.

2.50. The principal parties shall be able to demonstrate the effective fulfilment of the requirements for protection and safety in the management system.
Safety Culture
2.51. The principal parties shall promote and maintain safety culture by:

Promoting individual and collective commitment to protection and safety at all levels of the organization;

Ensuring a common understanding of the key aspects of safety culture within the organization;

Providing the means by which the organization supports individuals and teams in carrying out their tasks safely and successfully, with account taken of the interactions between individuals, technology and the organization;

Encouraging the participation of workers and their representatives and other relevant persons in the development and implementation of policies, rules and procedures dealing with protection and safety;

Ensuring accountability of the organization and of individuals at all levels for protection and safety;

Encouraging open communication with regard to protection and safety within the organization and with relevant parties, as appropriate;

Encouraging a questioning and learning attitude, and discouraging complacency, with regard to protection and safety;

Providing means by which the organization continually seeks to develop and strengthen its safety culture.

Human factors
2.52. The principal parties and other parties having specified responsibilities in relation to protection and safety, as appropriate, shall take into account human factors and shall support good performance and good practices to prevent human and organizational failures, by ensuring among other things that:

Sound ergonomic principles are followed in the design of equipment and the development of operating procedures, so as to facilitate the safe operation and use of equipment, to minimize the possibility that operator errors could lead to accidents, and to reduce the possibility that indications of normal conditions and abnormal conditions could be misinterpreted.

Appropriate equipment, safety systems and procedural requirements are provided, and other necessary provision is made:

(i) To reduce, as far as practicable, the possibility that human errors or inadvertent actions could give rise to accidents or to other incidents leading to the exposure of any person;

(ii) To provide means for detecting human errors and for correcting them or compensating for them;

(iii) To facilitate protective actions and corrective actions in the event of failures of safety systems or failures of measures for protection and safety.

Relevant Safety guides:

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-90 Radiation Protection Aspects of Design for Nuclear Power Plants

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education
3. Planned Exposure Situations Scope
3.1. The requirements for planned exposure situations apply to the following practices:

The production, supply, provision and transport of radioactive material and of devices that contain radioactive material, including sealed sources and unsealed sources, and of consumer products;

The production and supply of devices that generate radiation, including linear accelerators, cyclotrons, and fixed and mobile radiography equipment;

The generation of nuclear power, including any activities within the nuclear fuel cycle that involve or that could involve exposure to radiation or exposure due to radioactive material;

The use of radiation or radioactive material for medical, industrial, veterinary, agricultural, legal or security purposes, including the use of associated equipment, software or devices where such use could affect exposure to radiation;

The use of radiation or radioactive material for education, training or research, including any activities relating to such use that involve or could involve exposure to radiation or exposure due to radioactive material;

The mining and processing of raw materials that involve exposure due to radioactive material;

Any other practice as specified by the regulatory body.

3.2. The requirements for planned exposure situations apply to exposure due to sources within practices¹⁶16, as follows:

Facilities that contain radioactive material and facilities that contain radiation generators, including nuclear installations, medical radiation facilities, veterinary radiationfacilities, facilities for the management of radioactive waste, installations for the processing of radioactive material, irradiation facilities, and mineral extraction and mineral processing facilities that involve or could involve exposure to radiation or exposure due to radioactive material;

Individual sources of radiation, including sources within the types of facility mentioned in para. 3.2(a), as appropriate, in accordance with the requirements of the regulatory body.

You may also wish to read:

Safety Report No. 104, Radiation Protection and Safety in Veterinary Medicine

3.3. The requirements for planned exposure situations apply for any occupational exposure, medical exposure or public exposure due to any practice or due to a source within a practice as specified in paras 3.1 and 3.2.

3.4. Exposure due to natural sources is, in general, considered an existing exposure situation and is subject to the requirements in Section 5. However, the relevant requirements in Section 3 for planned exposure situations apply to:

Exposure due to material¹⁷17 in any practice specified in para. 3.1 where the activity concentration in the material of any radionuclide in the uranium decay chain or the thorium decay chain is greater than 1 Bq/g or the activity concentration of ⁴⁰K is greater than 10 Bq/g;

Public exposure due to discharges or due to the management of radioactive waste arising from a practice involving material as specified in (a) above;

Exposure due to ²²²Rn and to ²²²Rn progeny and due to ²²⁰Rn and to ²²⁰Rn progeny in workplaces in which occupational exposure due to other radionuclides in the uranium decay chain or the thorium decay chain is controlled as a planned exposure situation;

Exposure due to ²²²Rn and to ²²²Rn progeny where the annual average activity concentration of 222Rn in air in workplaces remains above the reference level established in accordance with para. 5.27 after the fulfilment of the requirement in para. 5.28.

Generic Requirements
3.5. No person or organization shall adopt, introduce, conduct, discontinue or cease a practice, or shall, as applicable, mine, extract, process, design, manufacture, construct, assemble, install, acquire, import, export, supply, provide, distribute, loan, hire, receive, site, locate, commission, possess, use, operate, maintain, repair, transfer, decommission, disassemble, transport, store or dispose of a source within a practice other than in accordance with the requirements of these Standards.
Requirement 6: Graded approach
The application of the requirements of these Standards in planned exposure situations shall be commensurate with the characteristics of the practice or the source within a practice, and with the likelihood and magnitude of exposures.

3.6. The application of the requirements of these Standards shall be in accordance with the graded approach and shall also conform to any requirements specified by the regulatory body. Not all the requirements of these Standards are relevant for every practice or source, or for all the actions specified in para. 3.5.

Relevant Safety guides:

RS-G-1.9 Categorization of Radioactive Sources

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education
Requirement 7: Notification and authorization
Any person or organization intending to operate a facility or to conduct an activity shall submit to the regulatory body a notification and, as appropriate, an application for authorization.

Notification

3.7. Any person or organization intending to carry out any of the actions specified in para. 3.5 shall submit a notification to the regulatory body of such an intention¹⁸18. Notification alone is sufficient provided that the exposures expected to be associated with the practice or action are unlikely to exceed a small fraction, as specified by the regulatory body, of the relevant limits, and that the likelihood and magnitude of potential exposures and any other potential detrimental consequences are negligible. Notification is required for consumer products only with respect to manufacture, maintenance, import, export, provision, distribution and, in some cases, disposal.

Authorization : Registration or licensing

3.8. Any person or organization intending to carry out any of the actions specified in para. 3.5 shall, unless notification alone is sufficient, apply to the regulatory body for authorization¹⁸, which shall take the form of either registration¹⁹19 or licensing.

3.9. Any person or organization applying for authorization:

Shall submit to the regulatory body the relevant information necessary to support the application;

Shall refrain from carrying out any of the actions specified in para. 3.5 until the registration or the licence has been issued;

Shall assess the nature, likelihood and magnitude of the expected exposures due to the source and shall take all necessary measures for protection and safety;

Shall, if there is a possibility for an exposure to be greater than a level as specified by the regulatory body, have a safety assessment made and submitted to the regulatory body as part of the application;

Shall, as required by the regulatory body, have an appropriate prospective assessment made for radiological environmental impacts, commensurate with the radiation risks associated with the facility or activity.

Relevant safety guides:

GSG-13 Functions and Processes of the Regulatory Body for Safety

GSG-17 Application of the Concept of Exemption

GSG-18 Application of the Concept of Clearance
Requirement 8: Exemption and clearance
The government or the regulatory body shall determine which practices or sources within practices are to be exempted from some or all of the requirements of these Standards. The regulatory body shall approve which sources, including materials and objects, within notified practices or authorized practices may be cleared from regulatory control.

Exemption

3.10. The government or the regulatory body shall determine which practices or sources within practices are to be exempted from some or all of the requirements of these Standards, including the requirements for notification, registration or licensing, using as the basis for this determination the criteria for exemption specified in Schedule I or any exemption levels specified by the regulatory body on the basis of these criteria.

3.11. Exemption shall not be granted for practices deemed to be not justified.

Clearance

3.12. The regulatory body shall approve which sources, including materials and objects, within notified or authorized practices may be cleared from regulatory control, using as the basis for such approval the criteria for clearance specified in Schedule I or any clearance levels specified by the regulatory body on the basis of these criteria. By means of this approval, the regulatory body shall ensure that sources that have been cleared from regulatory control do not again become subject to the requirements for notification, registration or licensing unless it so specifies.

Relevant Safety guides:

GSG-13 Functions and Processes of the Regulatory Body for Safety

GSG-17 Application of the Concept of Exemption

GSG-18 Application of the Concept of Clearance

SSG-36 Radiation Safety for Consumer Products

GSG-10 Prospective Radiological Environmental Impact Assessment for Facilities and Activities
Requirement 9: Responsibilities of registrants and licensees in planned exposure situations
Registrants and licensees shall be responsible for protection and safety in planned exposure situations.

3.13. Registrants and licensees shall bear the responsibility for setting up and implementing the technical and organizational measures that are necessary for protection and safety for the practices and sources for which they are authorized. Registrants and licensees may designate suitably qualified persons to carry out tasks relating to these responsibilities, but they shall retain the prime responsibility for protection and safety. Registrants and licensees shall document the names and responsibilities of persons designated to ensure compliance with the requirements of these Standards.

3.14. Registrants and licensees shall notify the regulatory body of any intention to introduce modifications to any practice or source for which they are authorized, whenever the modifications could have significant implications for protection and safety, and they shall not carry out any such modification unless it is specifically authorized by the regulatory body.

3.15. Registrants and licensees:

Shall establish clear lines of responsibility and accountability for protection and safety for the sources for which they are authorized, and shall establish organizational arrangements for protection and safety;

Shall ensure that any delegation of responsibilities by a principal party is documented;

Shall, for the sources for which they are authorized and for which a safety assessment is required in para. 3.9(d), conduct such a safety assessment and keep it up to date in accordance with para. 3.35;

Shall, for the sources for which they are authorized and for which the regulatory body requires a prospective assessment to be made for radiological environmental impacts (see para. 3.9(e)), conduct such an assessment and keep it up to date;

Shall assess the likelihood and magnitude of potential exposures, their likely consequences and the number of individuals who may be affected by them;

Shall have in place operating procedures and arrangements for protection and safety that are subject to periodic review and updating under a management system;

Shall establish procedures for reporting on and learning from accidents and other incidents;

Shall establish arrangements for the periodic review of the overall effectiveness of the measures for protection and safety;

Shall ensure that adequate maintenance, testing and servicing are carried out as necessary so that sources remain capable of fulfilling their designrequirements for protection and safety throughout their lifetime;

Shall ensure safe management of and control over all radioactive waste that is generated, and shall dispose of such waste in accordance with the regulatory requirements.

Requirement 10: Justification of practices
The government or the regulatory body shall ensure that only justified practices are authorized.

3.16. The government or the regulatory body, as appropriate, shall ensure that provision²⁰20 is made for the justification of any type of practice²¹21 and for review of the justification, as necessary, and shall ensure that only justified practices are authorized.

3.17. The following practices are deemed to be not justified:

Practices, except for justified practices involving medical exposure²²22, that result in an increase in activity, by the deliberate addition of radioactive substances or by activation²³23, in food, feed, beverages, cosmetics or any other commodity or product intended for ingestion, inhalation or percutaneous intake by, or application to, a person;

Practices involving the frivolous use of radiation or radioactive substances in commodities or in consumer products such as toys and personal jewellery or adornments, which result in an increase in activity, by the deliberate addition of radioactive substances or by activation²³;

Human imaging using radiation that is performed as a form of art or for publicity purposes.

3.18. Human imaging using radiation that is performed for occupational, legal or health insurance purposes²⁴24, and is undertaken without reference to clinical indication, shall normally be deemed to be not justified. If, in exceptional circumstances, the government or the regulatory body decides that the justification of such human imaging for specific practices is to be considered, the requirements of paras 3.61–3.64 and 3.66 shall apply.

3.19. Human imaging using radiation for theft detection purposes shall be deemed to be not justified.

3.20. Human imaging using radiation for the detection of concealed objects for anti-smuggling purposes shall normally be deemed to be not justified. If, in exceptional circumstances, the government or the regulatory body decides that the justification of such human imaging is to be considered, the requirements of paras 3.61–3.67 shall apply.

3.21. Human imaging using radiation for the detection of concealed objects that can be used for criminal acts that pose a national security threat shall be justified only by the government. If the government decides that the justification of such human imaging is to be considered, the requirements of paras 3.61–3.67 shall apply.

Relevant Safety guides:

GSG-5 Justification of Practices, Including Non-Medical Human Imaging
Requirement 11: Optimization of protection and safety
The government or the regulatory body shall establish and enforce requirements for the optimization of protection and safety, and registrants and licensees shall ensure that protection and safety is optimized.

3.22. The government or the regulatory body:

Shall establish and enforce requirements for the optimization of protection and safety;

Shall require documentation addressing the optimization of protection and safety;

Shall establish or approve constraints²⁵25 on dose and on risk, as appropriate, or shall establish or approve a process for establishing such constraints, to be used in the optimization of protection and safety.

3.23. Registrants and licensees shall ensure that protection and safety is optimized.

3.24. For occupational exposure and public exposure²⁶26, registrants and licensees shall ensure that all relevant factors are taken into account in a coherent way in the optimization of protection and safety to contribute to achieving the following objectives:

To determine measures for protection and safety that are optimized for the prevailing circumstances, with account taken of the available options for protection and safety as well as the nature, likelihood and magnitude of exposures;

To establish criteria, on the basis of the results of the optimization, for the restriction of the likelihood and magnitudes of exposures by means of measures for preventing accidents and for mitigating the consequences of those that do occur.

3.25. For occupational exposure and public exposure, registrants and licensees shall ensure, as appropriate, that relevant constraints are used in the optimization of protection and safety for any particular source within a practice.²⁵

Relevant Safety guides:

GSG-13 Functions and Processes of the Regulatory Body for Safety

GSG-9 Regulatory Control of Radioactive Discharges to the Environment

SSG-90 Radiation Protection Aspects of Design for Nuclear Power Plants
Requirement 12: Dose limits
The government or the regulatory body shall establish dose limits for occupational exposure and public exposure, and registrants and licensees shall apply these limits.

3.26. The government or the regulatory body shall establish and the regulatory body shall enforce compliance with the dose limits specified in Schedule III for occupational exposures and public exposures in planned exposure situations.

3.27. The government or the regulatory body shall determine what additional restrictions, if any, are required to be complied with by registrants and licensees to ensure that the dose limits specified in Schedule III are not exceeded owing to possible combinations of doses from exposures due to different authorized practices.

3.28. Registrants and licensees shall ensure that the exposures of individuals due to the practices for which the registrants and licensees are authorized are restricted, so that neither the effective dose nor the equivalent dose to tissues or organs exceeds any relevant dose limit specified in Schedule III.²⁷27

Relevant Safety guides:

GSG-13 Functions and Processes of the Regulatory Body for Safety

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors

GSG-10 Prospective Radiological Environmental Impact Assessment for Facilities and Activities
Requirement 13: Safety assessment
The regulatory body shall establish and enforce requirements for safety assessment, and the person or organization responsible for a facility or activity that gives rise to radiation risks shall conduct an appropriate safety assessment of this facility or activity.

3.29. The regulatory body shall establish requirements for persons or organizations responsible for facilities and activities that give rise to radiation risks to conduct an appropriate safety assessment²⁸28. Prior to the granting of an authorization, the responsible person or organization shall be required to submit a safety assessment, which shall be reviewed and assessed by the regulatory body.

3.30. The person or organization, as required under para. 3.9(d), or registrants and licensees, as appropriate, shall conduct a safety assessment that is either generic or specific to the practice or source for which they are responsible.²⁹29

3.31. Safety assessments shall be conducted at different stages, including the stages of siting, design, manufacture, construction, assembly, commissioning, operation, maintenance and decommissioning (or closure) of facilities or parts thereof, as appropriate, so as:

To identify the ways in which exposures could be incurred, account being taken of the effects of external events as well as of events directly involving the sources and associated equipment;

To determine the expected likelihood and magnitudes of exposures in normal operation and, to the extent reasonable and practicable, to make an assessment of potential exposures;

To assess the adequacy of the provisions for protection and safety.

3.32. The safety assessment shall include, as appropriate, a systematic critical review of:

The operational limits and conditions for the operation of the facility;

The ways in which structures, systems and components, including software, and procedures relating to protection and safety might fail, singly or in combination, or might otherwise give rise to exposures, and the consequences of such events;

The ways in which external factors could affect protection and safety;

The ways in which operating procedures relating to protection and safety might be erroneous, and the consequences of such errors;

The implications for protection and safety of any modifications;

The implications for protection and safety of security measures or of any modifications to security measures;

Any uncertainties or assumptions and their implications for protection and safety.

3.33. The registrant or licensee shall take into account in the safety assessment:

Factors that could give rise to a substantial release of radioactive material, the measures available to prevent or to control such a release, and the maximum activity of radioactive material that, in the event of a major failure of the containment, could be released to the environment;

Factors that could give rise to a smaller but continuing release of radioactive material, and the measures available to detect and to prevent or to control such a release;

Factors that could give rise to unintended operation of any radiation generator or a loss of shielding, and the measures available to detect and to prevent or to control such occurrences;

The extent to which the use of redundant and diverse safety features that are independent of each other, so that failure of one does not result in failure of any other, is appropriate to restrict the likelihood and magnitude of potential exposures.

3.34. Registrants and licensees shall ensure that the safety assessment is documented and, where appropriate, that it is independently reviewed under the relevant management system.

3.35. Registrants and licensees shall perform additional reviews of the safety assessment as necessary to ensure that the technical specifications or conditions of use continue to be met when:

Significant modifications to the facility or to its operating procedures or maintenanceprocedures are envisaged;

Significant changes occur on the site that could affect the safety of the facility or of activities on the site;

Information on operating experience, or information about accidents and other incidents that could result in exposures, indicates that the current assessment might be invalid;

Any significant changes in activities are envisaged;

Any relevant changes in guidelines or standards have been made or are envisaged.

3.36. If as a result of a safety assessment, or for any other reason, opportunities to improve protection and safety appear to be available and improvement seems desirable, any consequential modifications shall be made cautiously and only after favourable assessment of all the implications for protection and safety. The implementation of all improvements shall be prioritized so as to optimize protection and safety.

Relevant Safety guides:

GSG-19 Monitoring for Protection of the Public and the Environment

GSG-10 Prospective Radiological Environmental Impact Assessment for Facilities and Activities
Requirement 14: Monitoring for verification of compliance
Registrants and licensees and employers shall conduct monitoring to verify compliance with the requirements for protection and safety.

3.37. The regulatory body shall establish requirements that monitoring and measurements be performed to verify compliance with the requirements for protection and safety. The regulatory body shall be responsible for review and approval of the monitoring and measurement programmes of registrants and licensees.

3.38. Registrants and licensees and employers shall ensure that:

Monitoring and measurements of parameters are performed as necessary for verification of compliance with the requirements of these Standards;

Suitable equipment is provided and procedures for verification are implemented;

Equipment is properly maintained, tested and calibrated at appropriate intervals with reference to standards traceable to national or international standards;

Records are maintained of the results of monitoring and verification of compliance, as required by the regulatory body, including records of the tests and calibrations carried out in accordance with these Standards;

The results of monitoring and verification of compliance are shared with the regulatory body as required.

Relevant Safety guides:

GSG-19 Monitoring for Protection of the Public and the Environment

GSG-10 Prospective Radiological Environmental Impact Assessment for Facilities and Activities
Requirement 15: Prevention and mitigation of accidents
Registrants and licensees shall apply good engineering practice and shall take all practicable measures to prevent accidents and to mitigate the consequences of those accidents that do occur.

Good engineering practice

3.39. The registrant or licensee, in cooperation with other responsible parties, shall ensure that the siting, location, design, manufacture, construction, assembly, commissioning, operation, maintenance and decommissioning (or closure) of facilities or parts thereof are based on good engineering practice which shall, as appropriate:

Take account of international and national standards;

Be supported by managerial and organizational features, with the purpose of ensuring protection and safety throughout the lifetime of the facility;

Include adequate safety margins in the design and construction of the facility, and in operations involving the facility, so as to ensure reliable performance in normal operation, and take account of the necessary quality, redundancy and capability for inspection, with emphasis on preventing accidents, mitigating the consequences of those accidents that do occur and restricting any possible future exposures;

Take account of relevant developments concerning technical criteria, as well as the results of any relevant research on protection and safety and feedback of information on lessons learned from experience.

Defence in depth

3.40. Registrants and licensees shall ensure that a multilevel (defence in depth) system of sequential, independent provisions for protection and safety that is commensurate with the likelihood and magnitude of potential exposures is applied to sources for which the registrants and licensees are authorized.

Registrants and licensees shall ensure that if one level of protection were to fail, the subsequent independent level of protection would be available. Such defence in depth shall be applied for the purposes of:

Preventing accidents;

Mitigating the consequences of any accidents that do occur;

Restoring the sources to safe conditions after any such accidents.

Accident prevention

3.41. Registrants and licensees shall ensure that structures, systems and components, including software, that are related to protection and safety for facilities and activities are designed, constructed, commissioned, operated and maintained so as to prevent accidents as far as reasonably practicable.

3.42. The registrant or licensee for any facility or activity shall make suitable arrangements:

To prevent reasonably foreseeable accidents in the facility or the activity;

To mitigate the consequences of those accidents that do occur;

To provide workers with the information, instruction, training and equipment necessary to restrict potential exposures;

To ensure that there are adequate procedures for the control of the facility and for the management of any reasonably foreseeable accidents;

To ensure that safety significant structures, systems and components, including software, and other equipment can be inspected and tested regularly for any degradation that could lead to abnormal conditions or inadequate performance;

To ensure that maintenance, inspection and testing appropriate to the preservation of the provisions for protection and safety can be carried out without undue occupational exposure;

To provide, wherever appropriate, automatic systems for safely shutting off or reducing the release of radiation from facilities in the event that operating conditions are outside the stipulated ranges;

To ensure that abnormal operating conditions that could significantly affect protection and safety are detected by systems that respond quickly enough to allow for corrective action to be taken in a timely manner;

To ensure that all relevant safety documentation is available in the appropriate languages understandable to users.

Emergency preparedness and response

3.43. If the safety assessment indicates that there is a reasonable likelihood of an emergency affecting either workers or members of the public, the registrant or licensee shall prepare an emergency plan for the protection of people and the environment. As part of this emergency plan, the registrant or licensee shall include arrangements for the prompt identification of an emergency, and for determining the appropriate level of the emergency response [15]. In relation to the arrangements for the emergency response at the scene by the registrant or licensee, the emergency plan shall include, in particular:

Provision for individual monitoring and area monitoring, and arrangements for medical treatment;

Arrangements for assessing and mitigating any consequences of an emergency.

3.44. Registrants and licensees shall be responsible for the implementation of their emergency plans and shall be prepared to take any necessary action for effective response. To prevent the occurrence of conditions that could lead to a loss of control over a source or to the escalation of such conditions, registrants and licensees shall, as appropriate:

Develop, maintain and implement procedures to provide the means for preventing loss of control over the source and for regaining control over the source as necessary;

Make available equipment, instrumentation and diagnostic aids that may be needed;

Train and periodically retrain personnel in the procedures to be followed and exercise the procedures.

Relevant Safety guides:

GSG-19 Monitoring for Protection of the Public and the Environment

SSG-8 Radiation Safety of Gamma, Electron and X ray Irradiation Facilities

SSG-11 Radiation Safety in Industrial Radiography

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education
Requirement 16: Investigations and feedback of information on operating experience
Registrants and licensees shall conduct formal investigations of abnormal conditions arising in the operation of facilities or the conduct of activities, and shall disseminate information that is significant for protection and safety.

3.45. Registrants and licensees shall ensure that information on both normal operation and abnormal conditions that are significant for protection and safety is disseminated or made available, as appropriate, to the regulatory body and relevant parties, as specified by the regulatory body. This information would include, for example, details of doses associated with given activities, data on maintenance, descriptions of events and information on corrective actions, and information on operating experience from other relevant facilities and activities.

3.46. Registrants and licensees shall conduct an investigation as specified by the regulatory body in the event that:

A quantity or operating parameter relating to protection and safety exceeds an investigation level or is outside the stipulated range of operating conditions; or Any equipment failure, accident, error, mishap or other unusual event or condition occurs that has the potential for causing a quantity to exceed any relevant limit or operating restriction.

3.47. The registrant or licensee shall conduct an investigation as soon as possible after an event and shall prepare a written record of its causes, or suspected causes, including a verification or determination of any doses received or committed and recommendations for preventing the recurrence of the event and the occurrence of similar events.

3.48. The registrant or licensee shall communicate to the regulatory body and to any other relevant parties, as appropriate, a written report of any formal investigation relating to events as prescribed by the regulatory body, including exposures giving rise to doses exceeding a dose limit. The registrant or licensee shall also immediately report to the regulatory body any event in which a dose limit is exceeded.

Relevant Safety guides:

SSG-19 National Strategy for Regaining Control over Orphan Sources and Improving Control over Vulnerable Sources

SSG-17 Control of Orphan Sources and Other Radioactive Material in the Metal Recycling and Production Industries

SSG-8 Radiation Safety of Gamma, Electron and X ray Irradiation Facilities

SSG-11 Radiation Safety in Industrial Radiography
Requirement 17: Radiation generators and radioactive sources
Registrants and licensees shall ensure the safety of radiation generators and radioactive sources.

3.49. Registrants and licensees who are manufacturers or other suppliers of radiation generators and radioactive sources shall ensure that the following responsibilities are discharged, as applicable:

(a) Supplying a well designed, well manufactured and well constructed radiation generator or radioactive source and device in which the radiation generator or radioactive source is used that:

(i) Provides for protection and safety in accordance with the requirements of these Standards;

(ii) Meets engineering, performance and functional specifications;

(iii) Meets quality standards commensurate with the significance for protection and safety of systems and components, including software;

(iv) Provides clear displays, gauges and instructions on operating consoles in the appropriate language understandable to users.

(b) Ensuring that radiation generators and radioactive sources are tested to demonstrate compliance with the relevant specifications.

(c) Making information available, in the appropriate language understandable to users, on the proper installation and use of the radiation generator or radioactive source and on its associated radiation risks, including performance specifications, instructions for operating and maintenance, and instructions for protection and safety.

(d) Ensuring that the protection provided by shielding and by other protective devices is optimized.

3.50. Where applicable, registrants and licensees shall make suitable arrangements with suppliers of radiation generators and radioactive sources, the regulatory body and relevant parties for the purposes of:

Obtaining information on conditions of use and operating experience that may be important for protection and safety;

Providing feedback and information that may have implications for protection and safety for other users, or that may have implications for the possibility for improvements in protection and safety for radiation generators and radioactive sources.

3.51. When choosing a location to use or to store a radiation generator or radioactive source, registrants and licensees shall take into account:

Factors that could affect the safe management of and control over the radiation generator or radioactive source;

Factors that could affect occupational exposure and public exposure due to the radiation generator or radioactive source;

The feasibility of taking the foregoing factors into account in engineering design.

3.52. In selecting a site for a facility that will contain a large amount of radioactive material and that will have the potential for the release of significant amounts of radioactive material, registrants and licensees shall take into account features that might affect protection and safety, features that might affect the integrity or functioning of the facility, and the feasibility of carrying out off-siteprotective actions if they become necessary.

3.53. Registrants and licensees shall maintain an inventory that includes records of:

The location and description of each radiation generator or radioactive source for which they are responsible;

The activity and form of each radioactive source for which they are responsible.

3.54. Registrants and licensees shall provide the regulatory body as required with appropriate information from their inventory records of radiation generators and radioactive sources.

3.55. Registrants and licensees shall keep radiation generators and radioactive sources under control so as to prevent loss or damage and to prevent any unauthorized person from carrying out any of the activities specified in para. 3.5, by ensuring that:

Control over a radiation generator or radioactive source is relinquished only in compliance with all relevant requirements specified in the registration or licence;

The regulatory body is promptly notified of information regarding a radiation generator or radioactive source that is lost, missing or not under control;

A radiation generator or radioactive source is transferred only if the recipient possesses the necessary authorization;

An inventory, as required in para. 3.53, of radiation generators or radioactive sources is checked periodically to confirm that they are in their assigned locations and are under control.

3.56. Registrants and licensees shall ensure that sealed sources are categorized in accordance with the categorization scheme set out in Schedule II, and in accordance with the requirements of the regulatory body.

3.57. The manufacturer of a radioactive source or a device containing a radioactive source shall ensure that, where practicable, the source itself and its container are marked with the symbol recommended by the International Organization for Standardization [16]³⁰30.

3.58. Registrants and licensees, in cooperation with manufacturers, shall ensure that, where practicable, sealed sources are identifiable and traceable.

3.59. Registrants and licensees shall ensure that when radioactive sources are not in use they are stored in an appropriate manner for protection and safety.

3.60. Registrants and licensees shall ensure that arrangements are made promptly for the safe management of and control over radiation generators and radioactive sources, including appropriate financial provision, once it has been decided to take them out of use.

Relevant Safety guides:

RS-G-1.9 Categorization of Radioactive Sources

SSG-19 National Strategy for Regaining Control over Orphan Sources and Improving Control over Vulnerable Sources

SSG-17 Control of Orphan Sources and Other Radioactive Material in the Metal Recycling and Production Industries

SSG-8 Radiation Safety of Gamma, Electron and X ray Irradiation Facilities

SSG-11 Radiation Safety in Industrial Radiography
Requirement 18: Human imaging using radiation for purposes other than medical diagnosis, medical treatment or biomedical research
The government shall ensure that the use of ionizing radiation for human imaging for purposes other than medical diagnosis, medical treatment or biomedical research is subject to the system of protection and safety.

3.61. The government, if so decided in accordance with paras 3.18, 3.20 and 3.21, shall ensure that the requirements of para. 3.16 for the justification of practices are applied to any type of human imaging procedure in which radiation is used for purposes other than for medical diagnosis or medical treatment or other than as part of a programme of biomedical research. The justification process shall include the consideration of:

The benefits and detriments of implementing the type of human imaging procedure;

The benefits and detriments of not implementing the type of human imaging procedure;

Any legal or ethical issues associated with the introduction of the type of human imaging procedure;

The effectiveness and suitability of the type of human imaging procedure, including the appropriateness of the radiation equipment for the intended use;

The availability of sufficient resources to conduct the human imaging procedure safely throughout the intended period of the practice.

3.62. If it has been determined by means of the process specified in para. 3.61 that a particular practice of human imaging using radiation is justified, then such a practice shall be subject to regulatory control.

3.63. The regulatory body, in cooperation with other relevant authorities, agencies and professional bodies, as appropriate, shall establish the requirements for regulatory control of the practice and for review of the justification.

3.64. For human imaging using radiation, performed by medical personnel using medical radiological equipment, that exposes people to radiation for employment related, legal or health insurance³¹31 purposes without reference to clinical indications:

The government shall ensure, on the basis of consultation between relevant authorities, professional bodies and the regulatory body, that dose constraints are established for such human imaging;

The registrant or licensee shall ensure that the appropriate optimizationrequirements for medical exposure in paras 3.162–3.177 are applied, with dose constraints as required in (a) above used instead of diagnostic reference levels.

3.65. Procedures with inspection imaging devices in which radiation is used to expose persons for the purpose of detection of concealed weapons, contraband or other objects on or within the body shall be considered to give rise to public exposure. Registrants and licensees shall apply the requirements for public exposure in planned exposure situations. In particular, registrants and licensees shall ensure that optimization of protection and safety is subject to any dose constraints for public exposure set by the government or the regulatory body.

3.66. Registrants and licensees shall ensure that all persons who are to undergo procedures with inspection imaging devices in which ionizing radiation is used are informed of the possibility of requesting the use of an alternative inspection technique that does not use ionizing radiation, where available.

3.67. The registrant or licensee shall ensure that any inspection imaging device used for the detection of concealed objects on or within the body, whether it is manufactured in or imported into the State in which it is used, conforms to applicable standards of the International Electrotechnical Commission or the International Organization for Standardization or to equivalent national standards.

Relevant Safety guides:

GSG-5 Justification of Practices, Including Non-Medical Human Imaging

SSG-55 Radiation Safety of X Ray Generators and Other Radiation Sources Used for Inspection Purposes and for Non-medical Human Imaging
Occupational Exposures Scope
3.68. The requirements in respect of occupational exposure in planned exposure situations (paras 3.69–3.116) apply to occupational exposure due to a practice or a source within a practice, as stated in paras 3.1–3.3; and to occupational exposure as required in Section 4 for emergency exposure situations and as required in Section 5 for existing exposure situations. For exposure due to natural sources, these requirements for occupational exposure in planned exposure situations apply, as appropriate, only to the exposure situations specified in para. 3.4(a), and (d).
Requirement 19: Responsibilities of the regulatory body specific to occupational exposure
The government or the regulatory body shall establish and enforce requirements to ensure that protection and safety is optimized, and the regulatory body shall enforce compliance with dose limits for occupational exposure.

3.69. The government or the regulatory body shall establish the responsibilities of employers, registrants and licensees with regard to application of the requirements for occupational exposure in planned exposure situations.

3.70. The government or the regulatory body shall establish and enforce requirements to ensure that protection and safety is optimized for occupational exposure.

3.71. The government or the regulatory body shall establish, and the regulatory body shall enforce compliance with, the dose limits specified in Schedule III for occupational exposure.

3.72. Before authorization of a new or modified practice, the regulatory body shall require, as appropriate, and review supporting documents from the responsible parties that state:

Design criteria and design features relating to the exposure and potential exposure of workers in all operational states and in accident conditions;

Design criteria and design features of the appropriate systems and programmes for monitoring of workers for occupational exposure in all operational states and in accident conditions.

Relevant Safety guides:

GSG-12 Organization, Management and Staffing of the Regulatory Body for Safety

GSG-13 Functions and Processes of the Regulatory Body for Safety

GSG-7 Occupational Radiation Protection

SSG-44 Establishing the Infrastructure for Radiation Safety

You may also wish to read:

Safety Report Series No. 100 Occupational Radiation Protection in the Uranium Mining and Processing Industry
Requirement 20: Requirements for monitoring and recording of occupational exposures
The regulatory body shall establish and enforce requirements for the monitoring and recording of occupational exposures in planned exposure situations.

3.73. The regulatory body shall be responsible, as appropriate, for:

Establishment and enforcement of requirements for the monitoring, recording and control of occupational exposures in planned exposure situations in accordance with the requirements of these Standards;

Review of monitoring programmes of registrants and licensees, which shall be adequate to ensure that the requirements with regard to occupational exposure in planned exposure situations are fulfilled;

Authorization or approval of service providers for individual monitoring and calibration services;

Review of periodic reports on occupational exposure (including results of monitoring programmes and dose assessments) submitted by employers, registrants and licensees;

Provision for maintaining exposure records and results of the assessment of doses from occupational exposure;

Verification of compliance of an authorized practice with the requirements on the control of occupational exposure.

Relevant Safety guides:

GSG-7 Occupational Radiation Protection

GSG-13 Functions and Processes of the Regulatory Body for Safety

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors

You may also wish to read:

Safety Report Series No. 100 Occupational Radiation Protection in the Uranium Mining and Processing Industry
Requirement 21: Responsibilities of employers, registrants and licensees for the protection of workers
Employers, registrants and licensees shall be responsible for the protection of workers against occupational exposure. Employers, registrants and licensees shall ensure that protection and safety is optimized and that the dose limits for occupational exposure are not exceeded.

3.74. For workers who are engaged in activities in which they are or could be subject to occupational exposure in planned exposure situations, employers, registrants and licensees shall be responsible for:

Protection of workers against occupational exposure;

Compliance with other relevant requirements of these Standards.

3.75. Employers who are also registrants or licensees shall have the responsibilities of both employers and registrants or licensees.

3.76. Employers, registrants and licensees shall ensure, for all workers engaged in activities in which they are or could be subject to occupational exposure, that:

Occupational exposure is controlled so that the relevant dose limits for occupational exposure specified in Schedule III are not exceeded;

Protection and safety is optimized in accordance with the requirements of these Standards;

Decisions with regard to measures for protection and safety are recorded and made available to relevant parties, through their representatives where appropriate, as specified by the regulatory body;

Policies, procedures and organizational arrangements for protection and safety are established for implementing the relevant requirements of these Standards, with priority given to design measures and technical measures for controllingoccupational exposure;

Suitable and adequate facilities, equipment and services for protection and safety are provided, the type and extent of which are commensurate with the expected likelihood and magnitude of occupational exposure;

Necessary workers’ health surveillance and health services for workers are provided;

Appropriate monitoring equipment and personal protective equipment is provided and arrangements are made for its proper use, calibration, testing and maintenance;

Suitable and adequate human resources and appropriate training in protection and safety are provided, as well as periodic retraining as required to ensure the necessary level of competence;

Adequate records are maintained in accordance with the requirements of these Standards;

Arrangements are made to facilitate consultation of and cooperation with workers, through their representatives where appropriate, with regard to protection and safety on all measures necessary to achieve the effective application of these Standards;

Necessary conditions for promoting safety culture are provided.

3.77. Employers, registrants and licensees:

Shall involve workers, through their representatives where appropriate, in optimization of protection and safety;

Shall establish and use, as appropriate, constraints as part of optimization of protection and safety.

3.78. Employers, registrants and licensees shall ensure that workers exposed to radiation from sources within a practice that are not required by or directly related to their work have the same level of protection against such exposure as members of the public.

3.79. Employers, registrants and licensees shall take such administrative actions as are necessary to ensure that workers are informed that ensuring protection and safety is an integral part of a general occupational health and safety programme in which they have specific obligations and responsibilities for their own protection and the protection of others against radiation exposure and for the safety of sources.

3.80. Employers, registrants and licensees shall record any report received from a worker that identifies circumstances that could affect compliance with the requirements of these Standards, and shall take appropriate action.

3.81. Nothing in these Standards shall be construed as relieving employers from complying with applicable national and local laws and regulations governing hazards in the workplace.

3.82. Employers, registrants and licensees shall facilitate compliance by workers with the requirements of these Standards.

Relevant Safety guides:

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors
Requirement 22: Compliance by workers
Workers shall fulfil their obligations and carry out their duties for protection and safety.

3.83. Workers:

Shall follow any applicable rules and procedures for protection and safety as specified by the employer, registrant or licensee;

Shall use properly the monitoring equipment and personal protective equipment provided;

Shall cooperate with the employer, registrant or licensee with regard to protection and safety, and programmes for workers’ health surveillance and programmes for dose assessment;

Shall provide to the employer, registrant or licensee such information on their past and present work that is relevant for ensuring effective and comprehensive protection and safety for themselves and others;

Shall abstain from any wilful action that could put themselves or others in situations that would not be in accordance with the requirements of these Standards;

Shall accept such information, instruction and training in protection and safety as will enable them to conduct their work in accordance with the requirements of these Standards.

3.84. A worker who identifies circumstances that could adversely affect protection and safety shall report such circumstances to the employer, registrant or licensee as soon as possible.

Relevant Safety guides:

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors
Requirement 23: Cooperation between employers and registrants and licensees
Employers and registrants and licensees shall cooperate to the extent necessary for compliance by all responsible parties with the requirements for protection and safety.

3.85. If workers are engaged in work that involves or that could involve a source that is not under the control of their employer, the registrant or licensee responsible for the source and the employer shall cooperate to the extent necessary for compliance by both parties with the requirements of these Standards.

3.86. Cooperation between the employer and the registrant or licensee shall include, where appropriate:

The development and use of specific restrictions on exposure and other means of ensuring that the measures for protection and safety for workers who are engaged in work that involves or could involve a source that is not under the control of their employer are at least as good as those for employees of the registrant or licensee;

Specific assessments of the doses received by workers as specified in (a) above;

A clear allocation and documentation of the responsibilities of the employer and those of the registrant or licensee for protection and safety.

3.87. As part of the cooperation between parties, the registrant or licensee responsible for the source or for the exposure as appropriate:

Shall obtain from the employers, including self-employed persons, the previous occupational exposure history of workers as specified in para. 3.103, and any other necessary information;

Shall provide appropriate information to the employer, including any available information relevant for compliance with the requirements of these Standards that the employer requests;

Shall provide both the worker and the employer with the relevant exposure records.

Relevant Safety guides:

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors
Requirement 24: Arrangements under the radiation protection programme
Employers, registrants and licensees shall establish and maintain organizational, procedural and technical arrangements for the designation of controlled areas and supervised areas, for local rules and for monitoring of the workplace, in a radiation protection programme for occupational exposure.

Classification of areas : Controlled areas

3.88. Registrants and licensees shall designate as a controlled area any area³²32 in which specific measures for protection and safety are or could be required for:

Controlling exposures or preventing the spread of contamination in normal operation;

Preventing or limiting the likelihood and magnitude of exposures in anticipated operational occurrences and accident conditions.

3.89. In defining the boundaries of any controlled area, registrants and licensees shall take account of the magnitude of the exposures expected in normal operation, the likelihood and magnitude of exposures in anticipated operational occurrences and in accident conditions, and the type and extent of the procedures required for protection and safety.

3.90. Registrants and licensees:

Shall delineate controlled areas by physical means or, where this is not reasonably practicable, by some other suitable means.

Shall, where a source is only intermittently brought into operation or energized, or is moved from place to place, delineate an appropriate controlled area by means that are appropriate under the prevailing circumstances and shall specify exposure times.

Shall display the symbol recommended by the International Organization for Standardization [16] and shall display instructions at access points to and at appropriate locations within controlled areas.

Shall establish measures for protection and safety, including, as appropriate, physical measures to control the spread of contamination and local rules and procedures for controlled areas.

Shall restrict access to controlled areas by means of administrative procedures such as the use of work permits, and by physical barriers, which could include locks or interlocks, the degree of restriction being commensurate with the likelihood and magnitude of exposures.

Shall provide, as appropriate, at entrances to controlled areas:

(i) Personal protective equipment;

(ii) Equipment for individual monitoring and workplace monitoring;

(iii) Suitable storage for personal clothing.

Shall provide, as appropriate, at exits from controlled areas:

(i) Equipment for monitoring for contamination of skin and clothing;

(ii) Equipment for monitoring for contamination of any objects or material being removed from the area;

(iii) Washing or showering facilities and other personal decontaminationfacilities;

(iv) Suitable storage for contaminated personal protective equipment.

Shall periodically review conditions to assess whether there is any need to modify the measures for protection and safety or the boundaries of controlled areas;

Shall provide appropriate information, instruction and training for persons working in controlled areas.

Classification of areas : Supervised areas

3.91. Registrants and licensees shall designate as a supervised area any area not already designated as a controlled area but for which occupational exposure conditions need to be kept under review, even though specific measures for protection and safety are not normally needed.

3.92. Registrants and licensees, taking into account the nature, likelihood and magnitude of exposures or contamination in the supervised areas:

Shall delineate the supervised areas by appropriate means;

Shall display approved signs, as appropriate, at access points to supervised areas;

Shall periodically review conditions to assess whether there is any need for further measures for protection and safety or any need for changes to the boundaries of supervised areas.

Local rules and procedures and personal protective equipment

3.93. Employers, registrants and licensees shall minimize the need to rely on administrative controls and personal protective equipment for protection and safety by providing well engineered controls and satisfactory working conditions, in accordance with the following hierarchy of preventive measures:

Engineered controls;

Administrative controls;

Personal protective equipment.

3.94. Employers, registrants and licensees, in consultation with workers, or through their representatives where appropriate:

Shall establish in writing local rules and procedures that are necessary for protection and safety for workers and other persons;

Shall include in the local rules and procedures any relevant investigation level or authorized level, and the procedures to be followed in the event that any such level is exceeded;

Shall make the local rules and procedures and the measures for protection and safety known to those workers to whom they apply and to other persons who may be affected by them;

Shall ensure that any work in which workers are or could be subject to occupational exposure is adequately supervised and shall take all reasonable steps to ensure that the rules, procedures, and measures for protection and safety are observed;

Shall designate, as appropriate, a radiation protection officer in accordance with criteria established by the regulatory body.

3.95. Employers, registrants and licensees shall ensure that:

(a) Workers are provided with suitable and adequate personal protective equipment that meets relevant standards or specifications, including as appropriate:

(i) Protective clothing;

(ii) Respiratory protective equipment the characteristics of which are made known to the users;

(iii) Protective aprons, protective gloves and organ shields.

(b) Where appropriate, workers receive adequate instruction in the proper use of respiratory protective equipment, including testing for good fit.

(c) Tasks requiring the use of certain personal protective equipment are assigned only to workers who on the basis of medical advice are capable of safely sustaining the extra effort necessary.

(d) All personal protective equipment, including equipment for use in an emergency, is maintained in proper condition and, if appropriate, is tested at regular intervals.

(e) If the use of personal protective equipment is considered for any given task, account is taken of any additional exposure that could result owing to the additional time taken or the inconvenience, and of any non-radiological risks that might be associated with using personal protective equipment while performing the task.

Monitoring of the workplace

3.96. Registrants and licensees, in cooperation with employers where appropriate, shall establish, maintain and keep under review a programme for workplace monitoring under the supervision of a radiation protection officer or qualified expert.

3.97. The type and frequency of workplace monitoring:

(a) Shall be sufficient to enable:

(i) Evaluation of the radiological conditions in all workplaces;

(ii) Assessment of exposures in controlled areas and supervised areas;

(iii) Review of the classification of controlled areas and supervised areas.

(b) Shall be based on dose rate, activity concentration in air and surface contamination, and their expected fluctuations, and on the likelihood and magnitude of exposures in anticipated operational occurrences and accident conditions.

3.98. Registrants and licensees, in cooperation with employers where appropriate, shall maintain records of the findings of the workplace monitoring programme. The findings of the workplace monitoring programme shall be made available to workers, through their representatives where appropriate.

Relevant Safety guides:

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors

SSG-44 Establishing the Infrastructure for Radiation Safety
Requirement 25: Assessment of occupational exposure and workers’ health surveillance
Employers, registrants and licensees shall be responsible for making arrangements for assessment and recording of occupational exposures and for workers’ health surveillance.

Assessment of occupational exposure

3.99. Employers, as well as self-employed persons, and registrants and licensees shall be responsible for making arrangements for assessment of the occupational exposure of workers, on the basis of individual monitoring where appropriate, and shall ensure that arrangements are made with authorized or approved dosimetry service providers that operate under a quality management system.

3.100. For any worker who usually works in a controlled area, or who occasionally works in a controlled area and may receive a significant dose from occupational exposure, individual monitoring shall be undertaken where appropriate, adequate and feasible. In cases where individual monitoring of the worker is inappropriate, inadequate or not feasible, the occupational exposure shall be assessed on the basis of the results of workplace monitoring and information on the locations and durations of exposure of the worker³³33.

3.101. For any worker who regularly works in a supervised area or who enters a controlled area only occasionally, the occupational exposure shall be assessed on the basis of the results of workplace monitoring or individual monitoring, as appropriate.

3.102. Employers shall ensure that workers who could be subject to exposure due to contamination are identified, including workers who use respiratory protective equipment. Employers shall arrange for appropriate monitoring to the extent necessary to demonstrate the effectiveness of the measures for protection and safety and to assess intakes of radionuclides and the committed effective doses.

Records of occupational exposure

3.103. Employers, registrants and licensees shall maintain records of occupational exposure³⁴34 for every worker for whom assessment of occupational exposure is required in paras 3.99–3.102.

3.104. Records of occupational exposure for each worker shall be maintained during and after the worker’s working life, at least until the former worker attains or would have attained the age of 75 years, and for not less than 30 years after cessation of the work in which the worker was subject to occupational exposure.

3.105. Records of occupational exposure shall include:

Information on the general nature of the work in which the worker was subject to occupational exposure;

Information on dose assessments, exposures and intakes at or above the relevant recording levels specified by the regulatory body and the data upon which the dose assessments were based;

When a worker is or has been exposed while in the employ of more than one employer, information on the dates of employment with each employer and on the doses, exposures and intakes in each such employment;

Records of any assessments made of doses, exposures and intakes due to actions taken in an emergency or due to accidents or other incidents, which shall be distinguished from assessments of doses, exposures and intakes due to normal conditions of work and which shall include references to reports of any relevant investigations.

3.106. Employers, registrants and licensees:

Shall provide workers with access to records of their own occupational exposure;

Shall provide the supervisor of the programme for workers’ health surveillance, the regulatory body and the relevant employer with access to workers’ records of occupational exposure;

Shall facilitate the provision of copies of workers’ exposure records to new employers when workers change employment;

Shall make arrangements for the retention of exposure records for former workers by the employer, registrant or licensee, as appropriate;

Shall, in complying with (a)–(d) above, give due care and attention to maintaining the confidentiality of records.

3.107. If employers, registrants and licensees cease to conduct activities in which workers are subject to occupational exposure, they shall make arrangements for the retention of workers’ records of occupational exposure by the regulatory body or a State registry, or by a relevant employer, registrant or licensee, as appropriate.

Workers’ health surveillance

3.108. Programmes for workers’ health surveillance as required in para. 3.76(f):

Shall be based on the general principles of occupational health [19];

Shall be designed to assess the initial fitness and continuing fitness of workers for their intended tasks.

3.109. If one or more workers are to be engaged in work in which they are or could be exposed to radiation from a source that is not under the control of their employer, the registrant or licensee responsible for the source shall, as a precondition for the engagement of such workers, make with the employer any special arrangements for workers’ health surveillance that are needed to comply with the rules established by the regulatory body or other relevant authority.

Relevant Safety guides:

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors

GSG-7 Occupational Radiation Protection

You may also wish to read:

Safety Report Series No. 100 Occupational Radiation Protection in the Uranium Mining and Processing Industry
Requirement 26: Information, instruction and training
Employers, registrants and licensees shall provide workers with adequate information, instruction and training for protection and safety.

3.110. Employers, in cooperation with registrants and licensees:

Shall provide all workers with adequate information on health risks due to their occupational exposure in normal operation, anticipated operational occurrences and accident conditions, adequate instruction and training and periodic retraining in protection and safety, and adequate information on the significance of their actions for protection and safety;

Shall provide those workers who could be involved in or affected by the response to an emergency with appropriate information, and adequate instruction and training and periodic retraining, for protection and safety;

Shall maintain records of the training provided to individual workers.

Relevant Safety guides:

SSG-86 Radiation Protection Programmes for Transport Radioactive Material

SSG-87 Radiation Safety in the Use of Radiation Sources in Research and Education

SSG-40 Radiation Protection and Radioactive Waste Management in the Operation of Nuclear Power Plants

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors
Requirement 27: Conditions of service
Employers, registrants and licensees shall not offer benefits as substitutes for measures for protection and safety.

3.111. The conditions of service of workers shall be independent of whether they are or could be subject to occupational exposure. Special compensatory arrangements, or preferential consideration with respect to salary, special insurance coverage, working hours, length of vacation, additional holidays or retirement benefits, shall neither be granted nor be used as substitutes for measures for protection and safety in accordance with the requirements of these Standards.

3.112. Employers shall make all reasonable efforts to provide workers with suitable alternative employment in circumstances for which it has been determined, either by the regulatory body or in the framework of the programme for workers’ health surveillance in accordance with the requirements of these Standards, that workers, for health reasons, may no longer continue in employment in which they are or could be subject to occupational exposure.
Requirement 28: Special arrangements for protection and safety for female workers and for persons under 18 years of age undergoing training
Employers, registrants and licensees shall make special arrangements for female workers, as necessary, for protection of the embryo or fetus and breastfed infants. Employers, registrants and licensees shall make special arrangements for protection and safety for persons under 18 years of age who are undergoing training.

3.113. Employers, in cooperation with registrants and licensees, shall provide female workers who are liable to enter controlled areas or supervised areas or who may undertake emergency duties with appropriate information on:

The risk to the embryo or fetus due to exposure of a pregnant woman;

The importance for a female worker of notifying her employer as soon as possible if she suspects that she is pregnant³⁵35 or if she is breast-feeding;

The risk of health effects for a breastfed infant due to ingestion of radioactive substances.

3.114. Notification of the employer by a female worker if she suspects that she is pregnant or if she is breast-feeding shall not be considered a reason to exclude the female worker from work. The employer of a female worker, who has been notified of her suspected pregnancy or that she is breast-feeding, shall adapt the working conditions in respect of occupational exposure so as to ensure that the embryo or fetus or the breastfed infant is afforded the same broad level of protection as is required for members of the public.

3.115. Employers, registrants and licensees shall ensure that no person under the age of 16 years is or could be subject to occupational exposure.

3.116. Employers, registrants and licensees shall ensure that persons under the age of 18 years are allowed access to a controlled area only under supervision and only for the purpose of training for employment in which they are or could be subject to occupational exposure or for the purpose of studies in which sources are used.
Public Exposures Scope
3.117. The requirements in respect of public exposure in planned exposure situations (paras 3.118–3.144) apply to public exposure due to a practice or a source within a practice, as referred to in paras 3.1–3.3. For exposure due to natural sources, such requirements apply only to the types of public exposure specified in para. 3.4(a) and (b).
Requirement 29: Responsibilities of the government and the regulatory body specific to public exposure
The government or the regulatory body shall establish the responsibilities of relevant parties that are specific to public exposure, shall establish and enforce requirements for optimization, and shall establish, and the regulatory body shall enforce compliance with, dose limits for public exposure.

3.118. The government or the regulatory body shall establish the responsibilities of registrants and licensees, of suppliers, and of providers of consumer products³⁶36 in relation to the application of requirements for public exposure in planned exposure situations.

3.119. The government or the regulatory body shall establish and enforce requirements for the optimization of protection and safety for situations in which individuals are or could be subject to public exposure.

3.120. The government or the regulatory body shall establish or approve constraints on dose and constraints on risk to be used in the optimization of protection and safety for members of the public. When establishing or approving constraints in respect of a source within a practice, the government or the regulatory body shall take into account, as appropriate:

The characteristics of the source and of the practice that are of relevance for public exposure;

Good practice in the operation of similar sources;

Dose contributions from other authorized practices or from possible future authorized practices³⁷37, estimated at the design and planning stage, so that the total dose to members of the public is not expected to exceed the dose limit at any time after the start of operation of the source;

The views of interested parties.

3.121. The government or the regulatory body shall establish, and the regulatory body shall enforce compliance with, the dose limits specified in Schedule III for public exposure.

3.122. Before authorization of a new or modified practice, the regulatory body shall require the submission of, and shall review, the safety assessments (paras 3.29–3.36) and other design related documents from the responsible parties that address the optimization of protection and safety, the design criteria and the design features relating to the assessment of exposure and potential exposure of members of the public.

3.123. The regulatory body shall establish or approve operational limits and conditions relating to public exposure, including authorized limits for discharges.

These operational limits and conditions:

Shall be used by registrants and licensees as the criteria for demonstration of compliance after the commencement of operation of a source;

Shall correspond to doses below the dose limits with account taken of the results of optimization of protection and safety;

Shall reflect good practice in the operation of similar facilities or activities;

Shall allow for operational flexibility;

Shall take into account the results of the prospective assessment for radiological environmental impacts that is undertaken in accordance with requirements of the regulatory body (see paras 3.9(e) and 3.15(d)).

3.124. When a source within a practice could causepublic exposure outside the territory or other area under the jurisdiction or control of the State in which the source is located, the government or the regulatory body:

Shall ensure that the assessment for radiological impacts includes those impacts outside the territory or other area under the jurisdiction or control of the State;

Shall, to the extent possible, establish requirements for the control of discharges;

Shall arrange with the affected State the means for the exchange of information and consultations, as appropriate.

Relevant Safety guides:

GSG-19 Monitoring for Protection of the Public and the Environment

GSG-13 Functions and Processes of the Regulatory Body for Safety

GSG-9 Regulatory Control of Radioactive Discharges to the Environment
Requirement 30: Responsibilities of relevant parties specific to public exposure
Relevant parties shall apply the system of protection and safety to protect members of the public against exposure.

General considerations

3.125. Registrants and licensees, in cooperation with suppliers and with providers of consumer products, shall apply the requirements of these Standards and shall verify and demonstrate compliance with them, as specified by the regulatory body, in relation to any public exposure delivered by a source for which they have responsibility.

3.126. Registrants and licensees, in cooperation with suppliers, in applying the principle of optimization of protection and safety in the design, planning, operation and decommissioning of a source (or for closure and the post-closure period for wastedisposal facilities), shall take into account:

Possible changes in any conditions that could affect exposure of members of the public, such as changes in the characteristics and use of the source,

changes in environmental dispersion conditions, changes in exposure pathways or changes in values of parameters used for the determination of the representative person;

Good practice in the operation of similar sources or the conduct of similar practices;

Possible buildup and accumulation in the environment of radioactive substances from discharges during the lifetime of the source;

Uncertainties in the assessment of doses, especially uncertainties in contributions to doses if the source and the representative person are separated in space or in time.

3.127. Registrants and licensees, for sources under their responsibility, shall establish, implement and maintain:

(a) Policies, procedures and organizational arrangements for protection and safety in relation to public exposure, in accordance with the requirements of these Standards.

(b) Measures for ensuring:

(i) Optimization of protection and safety;

(ii) Limitation of exposure of members of the public from such sources, in accordance with the authorization.

(c) Measures for ensuring the safety of such sources.

(d) Provision for suitable and adequate resources (including facilities, equipment and services) for the protection and safety of members of the public, commensurate with the likelihood and magnitude of exposures.

(e) Programmes for appropriate training of personnel having functions relevant to protection and safety of members of the public, as well as periodic retraining as required, to ensure the necessary level of competence.

(f) Provision for appropriate monitoring equipment, monitoring programmes and methods for assessing public exposure.

(g) Adequate records of monitoring programmes.

(h) Emergency plans, emergency procedures and emergency arrangements, in accordance with the nature and magnitude of the radiation risks associated with the sources.

Visitors

3.128. Registrants and licensees, in cooperation with employers where appropriate:

Shall apply the relevant requirements of these Standards in respect of public exposure for visitors to a controlled area or a supervised area;

Shall ensure that visitors are accompanied in any controlled area by a person who knows the measures for protection and safety for the controlled area;

Shall provide adequate information and instructions to visitors before they enter a controlled area or a supervised area, so as to provide for protection and safety for visitors and for other individuals who could be affected by their actions;

Shall ensure that adequate control is maintained over the entry of visitors to a controlled area or a supervised area, including the use of signs for such areas.

External exposure and contamination in areas accessible to members of the public

3.129. Registrants and licensees shall ensure that if a source can give rise to external exposure of members of the public:

The floor plans and arrangements of equipment for all new installations utilizing such sources, as well as all significant modifications to existing installations, are subject, as appropriate, to review and approval by the regulatory body prior to commissioning;

Shielding and other measures for protection and safety, including access control, are provided as appropriate for restricting public exposure, in particular at open sites such as for some applications of industrial radiography.

3.130. Registrants and licensees shall ensure, as appropriate, that:

Specific provisions for confinement are established for the design and operation of a source that could cause the spread of contamination in areas that are accessible to members of the public;

Measures for protection and safety are implemented for restricting public exposure due to contamination in areas within a facility that are accessible to members of the public.

Relevant Safety guides:

GSG-12 Organization, Management and Staffing of the Regulatory Body for Safety

GSG-13 Functions and Processes of the Regulatory Body for Safety

GSG-9 Regulatory Control of Radioactive Discharges to the Environment

GSG-10 Prospective Radiological Environmental Impact Assessment for Facilities and Activities

GSG-19 Monitoring for Protection of the Public and the Environment
Requirement 31: Radioactive waste and discharges
Relevant parties shall ensure that radioactive waste and discharges of radioactive material to the environment are managed in accordance with the authorization.

Radioactive waste

3.131. Registrants and licensees, in cooperation with suppliers, as appropriate:

Shall ensure that any radioactive waste generated is kept to the minimum practicable in terms of both activity and volume;

Shall ensure that radioactive waste is managed in accordance with the requirements of these Standards and the requirements of other applicable IAEA standards, and in accordance with the relevant authorization;

Shall ensure that there is separate processing of radioactive waste of different types, where warranted by differences in factors such as radionuclide content, half-life, activity concentration, volume, and physical and chemical properties, taking into account the available options for storage and disposal of radioactive waste, without precluding the mixing of radioactive waste for purposes of protection and safety;

Shall ensure that activities for the predisposal management of and for the disposal of radioactive waste are conducted in accordance with the requirements of applicable IAEA standards³⁸38, and in accordance with the authorization;

Shall maintain an inventory of all radioactive waste that is generated, stored, transferred or disposed of;

Shall develop and implement a strategy for radioactive waste management and shall include appropriate evidence that protection and safety is optimized.

Discharges

3.132. Registrants and licensees, in cooperation with suppliers, in applying for an authorization for discharges, as appropriate:

Shall determine the characteristics and activity of the material to be discharged, and the possible points and methods of discharge;

Shall determine by an appropriate pre-operational study all significant exposure pathways by which discharged radionuclides could give rise to exposure of members of the public;

Shall assess the doses to the representative person due to the planned discharges;

Shall consider the radiological environmental impacts in an integrated manner with features of the system of protection and safety, as required by the regulatory body;

Shall submit to the regulatory body the findings of (a)–(d) above as an input to the establishment by the regulatory body, in accordance with para. 3.123, of authorized limits on discharges and conditions for their implementation.

3.133. Registrants and licensees shall ensure that operational limits and conditions relating to public exposure are met in accordance with paras 3.123 and 3.124.

3.134. Registrants and licensees shall review and modify their dischargecontrol measures, as appropriate and in agreement with the regulatory body, taking into account:

Operating experience;

Any changes in exposure pathways or in the characteristics of the representative person that could affect the assessment of doses due to the discharges.

Relevant Safety guides:

GSG-13 Functions and Processes of the Regulatory Body for Safety

GSG-9 Regulatory Control of Radioactive Discharges to the Environment

GSG-10 Prospective Radiological Environmental Impact Assessment for Facilities and Activities

GSG-19 Monitoring for Protection of the Public and the Environment
Requirement 32: Monitoring and reporting
The regulatory body and relevant parties shall ensure that programmes for source monitoring and environmental monitoring are in place and that the results from the monitoring are recorded and are made available.

3.135. The regulatory body shall be responsible, as appropriate, for:

(a) Review and approval of monitoring programmes of registrants and licensees, which shall be sufficient for:

(i) Verifying compliance with the requirements of these Standards in respect of public exposure in planned exposure situations;

(ii) Assessing doses from public exposure.

(b) Review of periodic reports on public exposure (including results of monitoring programmes and dose assessments) submitted by registrants and licensees.

(c) Making provision for an independent monitoring programme.

(d) Assessment of the total public exposure due to authorized sources and practices in the State on the basis of monitoring data provided by registrants and licensees and with the use of data from independent monitoring and assessments.

(e) Making provision for maintaining records of discharges, results of monitoring programmes and results of assessments of public exposure.

(f) Verification of compliance of an authorized practice with the requirements of these Standards for the control of public exposure.

3.136. The regulatory body shall publish or shall make available on request, as appropriate, results from source monitoring and environmental monitoring programmes and assessments of doses from public exposure.

3.137. Registrants and licensees shall, as appropriate:

(a) Establish and implement monitoring programmes to ensure that public exposure due to sources under their responsibility is adequately assessed and that the assessment is sufficient to verify and demonstrate compliance with the authorization. These programmes shall include monitoring of the following, as appropriate:

(i) External exposure due to such sources;

(ii) Discharges;

(iii) Radioactivity in the environment;

(iv) Other parameters important for the assessment of public exposure.

(b) Maintain appropriate records of the results of the monitoring programmes and estimated doses to members of the public.

(c) Report or make available to the regulatory body the results of the monitoring programme at approved intervals, including, as applicable, the levels and composition of discharges, dose rates at the site boundary and in premises open to members of the public, results of environmental monitoring and retrospective assessments of doses to the representative person.

(d) Report promptly to the regulatory body any levels exceeding the operational limits and conditions relating to public exposure, including authorized limits on discharges, in accordance with reporting criteria established by the regulatory body.

(e) Report promptly to the regulatory body any significant increase in dose rate or concentrations of radionuclides in the environment that could be attributed to the authorized practice, in accordance with reporting criteria established by the regulatory body.

(f) Establish and maintain a capability to conduct monitoring in an emergency in the event of unexpected increases in radiation levels or in concentrations of radionuclides in the environment due to an accident or other unusual event attributed to the authorized source or facility.

(g) Verify the adequacy of the assumptions made for the assessment of public exposure and the assessment for radiological environmental impacts.

(h) Publish or make available on request, as appropriate, results from source monitoring and environmental monitoring programmes and assessments of doses from public exposure.

Relevant Safety guides:

GSG-9 Regulatory Control of Radioactive Discharges to the Environment

GSG-19 Monitoring for Protection of the Public and the Environment
Requirement 33: Consumer products
Providers of consumer products shall ensure that consumer products are not made available to the public unless their use by members of the public has been justified, and either their use has been exempted or their provision to the public has been authorized.

3.138. Providers of consumer products shall ensure that consumer products are not made available to the public unless the justification of their use by members of the public has been approved by the government or the regulatory body, and either their use has been exempted on the basis of the criteria specified in Schedule I or their provision to the public has been authorized.

3.139. Upon receipt of a request for authorization to provide consumer products to the public, the regulatory body:

Shall require the provider of the consumer product to provide documents to demonstrate compliance with the requirements in paras 3.138–3.144;

Shall verify the assessments and the selection of parameters presented in the request for authorization;

Shall determine whether the end use of the consumer product can be exempted;

Shall authorize the provision to the public of the consumer product, where appropriate, subject to specific conditions of authorization.

3.140. Providers of consumer products:

Shall comply with the conditions of the authorization to provide consumer products to the public;

Shall ensure that consumer products comply with the requirements of these Standards;

Shall plan for appropriate arrangements for the servicing, maintenance, recycling or disposal of consumer products.

3.141. The design and manufacture of consumer products, with regard to features that could affect exposure during normal handling, transport and use, as well as in the event of mishandling, misuse, accident or disposal, shall be subject to the optimization of protection and safety. In this regard, designers, manufacturers and other providers of consumer products shall take into account the following:

The various radionuclides that could be used in consumer products and their radiation types, energies, activities and half-lives;

The chemical and physical forms of the radionuclides that could be used in consumer products and their significance for protection and safety in normal conditions and abnormal conditions;

The containment and shielding of radioactive substances in consumer products and access to these radioactive substances in normal conditions and abnormal conditions;

The need for servicing or repair of consumer products and ways in which this could be done;

Relevant experience with similar consumer products.

3.142. Providers of consumer products shall ensure that:

(a) Where practicable, a legible label is firmly affixed to a visible surface of each consumer product that:

(i) States that the consumer product contains radioactive substances and identifies the radionuclides and their activities;

(ii) States that the provision of the consumer product to the public has been authorized by the regulatory body;

(iii) Provides information on required or recommended options for recycling or disposal.

(b) The information specified in (a) above is also printed legibly on the retail packaging of the consumer product.

3.143. Providers of consumer products shall provide clear and appropriate information and instructions with each consumer product on:

Correct installation, use and maintenance of the consumer product;

Servicing and repair;

The radionuclides and their activities at a specified date;

Dose rates in normal operation and during servicing and repair;

Required or recommended options for recycling or disposal.

3.144. Providers of consumer products shall provide the consumer product retailers with appropriate information on safety and instructions on their transport and storage.

Relevant Safety guides:

GSG-13 Functions and Processes of the Regulatory Body for Safety

SSG-36 Radiation Safety for Consumer Products
Medical Exposures Scope
3.145. The requirements in respect of medical exposure in planned exposure situations (paras 3.146–3.185) apply to all medical exposures³⁹39, including intended, unintended and accidental exposures.

3.146. Dose limits do not apply to medical exposures.
Requirement 34: Responsibilities of the government specific to medical exposure
The government shall ensure that relevant parties are authorized to assume their roles and responsibilities, and that diagnostic reference levels, dose constraints, and criteria and guidelines for the release of patients are established.

3.147. The government, in accordance with paras 2.13–2.28, shall ensure with regard to medical exposures that, as a result of consultation between the health authority, relevant professional bodies and the regulatory body, the relevant parties identified in paras 2.40 and 2.41 are authorized to assume their roles and responsibilities, and shall ensure that they are notified of their duties in relation to protection and safety for individuals undergoing medical exposures.

3.148. The government shall ensure, as part of the responsibilities specified in para. 2.15, that as a result of consultation between the health authority, relevant professional bodies and the regulatory body, a set of diagnostic reference levels is established for medical exposures incurred in medical imaging, including image guided interventional procedures. In setting such diagnostic reference levels, account shall be taken of the need for adequate image quality, to enable the requirements of para. 3.169 to be fulfilled. Such diagnostic reference levels shall be based, as far as possible, on wide scale surveys or on published values that are appropriate for the local circumstances.

3.149. The government shall ensure that, as a result of consultation between the health authority, relevant professional bodies and the regulatory body, the following are established:

(a) Dose constraints, to enable the requirements of paras 3.173 and 3.174, respectively, to be fulfilled for:

(i) Exposures of carers and comforters⁴⁰40;

(ii) Exposures due to diagnostic investigations of volunteers participating in a programme of biomedical research.

(b) Criteria and guidelines for the release of patients who have undergone therapeutic radiological procedures using unsealed sources or patients who still retain implanted sealed sources.

See also:

GSR Part 1 (Rev. 1) , Governmental, Legal and Regulatory Framework for Safety,

as well as

SSG-46 Radiological Protection and Safety in Medical Uses of Ionizing Radiation
Requirement 35: Responsibilities of the regulatory body specific to medical exposure
The regulatory body shall require that health professionals with responsibilities for medical exposure are specialized in the appropriate area and that they fulfil the requirements for education, training and competence in the relevant specialty.

3.150. The regulatory body shall ensure that the authorization for medical exposures to be performed at a particular medical radiation facility allows personnel (radiological medical practitioners, medical physicists, medical radiation technologists and any other health professionals with specific duties in relation to the radiation protection of patients) to assume the responsibilities specified in these Standards only if they:

Are specialized⁴¹41 in the appropriate area⁴²42;

Meet the respective requirements for education, training and competence in radiation protection, in accordance with para. 2.32;

Are named in a list maintained up to date by the registrant or licensee.

See also:

SSG-46 Radiological Protection and Safety in Medical Uses of Ionizing Radiation
Requirement 36: Responsibilities of registrants and licensees specific to medical exposure
Registrants and licensees shall ensure that no person incurs a medical exposure unless there has been an appropriate referral, responsibility has been assumed for ensuring protection and safety, and the person subject to exposure has been informed as appropriate of the expected benefits and risks.

3.151. Registrants and licensees shall ensure that no patient, whether symptomatic or asymptomatic, undergoes a medical exposure unless:

It is a radiological procedure that has been requested by a referring medical practitioner and information on the clinical context has been provided, or it is part of an approved health screening programme;

The medical exposure has been justified by means of consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate, or it is part of an approved health screening programme;

A radiological medical practitioner has assumed responsibility for protection and safety in the planning and delivery of the medical exposure as specified in para. 3.154(a);

The patient or the patient’s legal authorized representative has been informed as appropriate of the expected diagnostic or therapeutic benefits of the radiological procedure as well as the radiation risks.

3.152. Registrants and licensees shall ensure that no individual incurs a medical exposure as part of a programme of biomedical research unless the exposure has been approved by an ethics committee (or other institutional body that has been assigned functions similar to those of an ethics committee by the relevant authority) as required in para. 3.161 and a radiological medical practitioner has assumed responsibility as specified in para. 3.154(a). Registrants and licensees shall ensure that the requirements specified in para. 3.174 are fulfilled for the optimization of protection and safety for persons subject to exposure as part of a programme of biomedical research.

3.153. Registrants and licensees shall ensure that no individual incurs a medical exposure as a carer or comforter unless he or she has received, and has indicated an understanding of, relevant information on radiation protection and information on the radiation risks prior to providing care and comfort to an individual undergoing a radiological procedure. Registrants and licensees shall ensure that the requirements specified in para. 3.173 are fulfilled for the optimization of protection and safety for any radiological procedure in which an individual acts as a carer or comforter.

3.154. Registrants and licensees shall ensure that:

The radiological medical practitioner performing or overseeing the radiological procedure has assumed responsibility for ensuring overall protection and safety for patients in the planning and delivery of the medical exposure, including the justification of the radiological procedure as required in paras 3.155–3.161 and the optimization of protection and safety, in cooperation with the medical physicist and the medical radiation technologist as required in paras 3.162–3.177;

Radiological medical practitioners, medical physicists, medical radiation technologists and other health professionals with specific duties in relation to protection and safety for patients in a given radiological procedure are specialized in the appropriate area;

Sufficient medical personnel and paramedical personnel are available as specified by the health authority;

For therapeutic radiological procedures, the requirements of these Standards for calibration, dosimetry and quality assurance, including the acceptance and commissioning of medical radiological equipment, as specified in paras 3.167, 3.168(c), 3.170 and 3.171, are fulfilled by or under the supervision of a medical physicist;

For diagnostic radiological procedures and image guided interventional procedures, the requirements of these Standards for medical imaging, calibration, dosimetry and quality assurance, including the acceptance and commissioning of medical radiological equipment, as specified in

paras 3.167, 3.168(a) and (b), 3.169, 3.170 and 3.171, are fulfilled by or under the oversight of or with the documented advice of a medical physicist, whose degree of involvement is determined by the complexity of the radiological procedures and the associated radiation risks;

Any delegation of responsibilities by a principal party is documented.

See also:

SSG-46 Radiological Protection and Safety in Medical Uses of Ionizing Radiation
Requirement 37: Justification of medical exposures
Relevant parties shall ensure that medical exposures are justified.

3.155. Medical exposures shall be justified by weighing the diagnostic or therapeutic benefits⁴³43 that they are expected to yield against the radiation detriment that they might cause, with account taken of the benefits and the risks of available alternative techniques that do not involve medical exposure.

3.156. Generic justification of a radiological procedure shall be carried out by the health authority in conjunction with appropriate professional bodies, and shall be reviewed from time to time, with account taken of advances in knowledge and technological developments.

3.157. The justification of medical exposure for an individual patient shall be carried out by means of consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate, with account taken, in particular for patients who are pregnant or breast-feeding or are paediatric, of:

The appropriateness of the request;

The urgency of the radiological procedure;

The characteristics of the medical exposure;

The characteristics of the individual patient;

Relevant information from the patient’s previous radiological procedures.

3.158. Relevant national or international referral guidelines shall be taken into account for the justification of the medical exposure of an individual patient in a radiological procedure.

3.159. Justification for radiological procedures to be performed as part of a health screening programme for asymptomatic populations shall be carried out by the health authority in conjunction with appropriate professional bodies.

3.160. Any radiological procedure on an asymptomatic individual that is intended to be performed for the early detection of disease, but not as part of an approved health screening programme, shall require specific justification for that individual by the radiological medical practitioner and the referring medical practitioner, in accordance with the guidelines of relevant professional bodies or the health authority. As part of this process, the individual shall be informed in advance of the expected benefits, risks and limitations of the radiological procedure.

3.161. The medical exposure of volunteers as part of a programme of biomedical research is deemed to be not justified unless:

It is in accordance with the provisions of the Helsinki Declaration [20] and takes into account the guidelines published by the Council for International Organizations of Medical Sciences [21], together with the recommendations of the ICRP [22];

It is subject to approval by an ethics committee (or other institutional body that has been assigned functions similar to those of an ethics committee by the relevant authority), subject to any dose constraints that may be specified (as required in paras 3.149(a)(ii) and 3.174), and subject to applicable national regulations and local regulations.

See also:

SSG-46 Radiological Protection and Safety in Medical Uses of Ionizing Radiation
Requirement 38: Optimization of protection and safety
Registrants and licensees and radiological medical practitioners shall ensure that protection and safety is optimized for each medical exposure.

Design considerations

3.162. In addition to ensuring that the responsibilities stated in para. 3.49 are discharged, as applicable, registrants and licensees, in cooperation with suppliers, shall ensure that medical radiological equipment and software that could influence the delivery of medical exposure are used only if they conform to the applicable standards of the International Electrotechnical Commission and the International Organization for Standardization or to national standards adopted by the regulatory body.

Operational considerations

3.163. For diagnostic radiological procedures and image guided interventional procedures, the radiological medical practitioner, in cooperation with the medical radiation technologist and the medical physicist, and if appropriate with the radiopharmacist or radiochemist, shall ensure that the following are used:

Appropriate medical radiological equipment and software, and, for nuclear medicine, appropriate radiopharmaceuticals;

Appropriate techniques and parameters to deliver a medical exposure of the patient that is the minimum necessary to fulfil the clinical purpose of the radiological procedure, with account taken of relevant norms of acceptable image quality established by relevant professional bodies and of relevant diagnostic reference levels established in accordance with paras 3.148 and 3.169.

3.164. For therapeutic radiological procedures, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, shall ensure that for each patient the exposure of volumes other than the planning target volume is kept as low as reasonably achievable consistent with delivery of the prescribed dose to the planning target volume within the required tolerances.

3.165. For therapeutic radiological procedures in which radiopharmaceuticals are administered, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, and if appropriate with the radiopharmacist or radiochemist, shall ensure that for each patient the appropriate radiopharmaceutical with the appropriate activity is selected and administered, so that the radioactivity is primarily localized in the organ(s) of interest, while the radioactivity in the rest of the body is kept as low as reasonably achievable.

3.166. Registrants and licensees shall ensure that the particular aspects of medical exposures are considered in the optimization process for:

Paediatric patients subject to medical exposure;

Individuals subject to medical exposure as part of an approved health screening programme;

Volunteers subject to medical exposure as part of a programme of biomedical research;

Relatively high doses⁴⁴44 to the patient;

Exposure of the embryo or fetus, in particular for radiological procedures in which the abdomen or pelvis of the pregnant female patient is exposed to the useful radiation beam or could otherwise receive a significant dose;

Exposure of a breastfed infant as a result of a female patient having undergone a radiological procedure with radiopharmaceuticals.

Calibration

3.167. In accordance with para. 3.154(d) and (e), the medical physicist shall ensure that:

All sources giving rise to medical exposure are calibrated in terms of appropriate quantities using internationally accepted or nationally accepted protocols;

Calibrations are carried out at the time of commissioning a unit prior to clinical use, after any maintenanceprocedure that could affect the dosimetry and at intervals approved by the regulatory body;

Calibrations of radiation therapy units are subject to independent verification⁴⁵45 prior to clinical use;

Calibration of all dosimeters used for dosimetry of patients and for the calibration of sources is traceable to a standards dosimetry laboratory.

Dosimetry of patients

3.168. Registrants and licensees shall ensure that dosimetry of patients is performed and documented by or under the supervision of a medical physicist, using calibrated dosimeters and following internationally accepted or nationally accepted protocols, including dosimetry to determine the following:

For diagnostic radiological procedures, typical doses to patients for common procedures;

For image guided interventional procedures, typical doses to patients;

For therapeutic radiological procedures, absorbed doses to the planning target volume for each patient treated with external beam therapy and/or brachytherapy and absorbed doses to relevant tissues or organs as determined by the radiological medical practitioner;

For therapeutic radiological procedures with unsealed sources, typical absorbed doses to patients.

Diagnostic reference levels

3.169. Registrants and licensees shall ensure that:

(a) Local assessments, on the basis of the measurements required in para. 3.168, are made at approved intervals for those radiological procedures for which diagnostic reference levels have been established (para. 3.148).

(b) A review is conducted to determine whether the optimization of protection and safety for patients is adequate, or whether corrective action is required if, for a given radiological procedure:

(i) Typical doses or activities exceed the relevant diagnostic reference level; or

(ii) Typical doses or activities fall substantially below the relevant diagnostic reference level and the exposures do not provide useful diagnostic information or do not yield the expected medical benefit to the patient.

Quality assurance for medical exposures

3.170. Registrants and licensees, in applying the requirements of these Standards in respect of management systems, shall establish a comprehensive programme of quality assurance for medical exposures with the active participation of medical physicists, radiological medical practitioners, medical radiation technologists and, for complex nuclear medicine facilities, radiopharmacists and radiochemists, and in conjunction with other health professionals as appropriate. Principles established by the World Health Organization, the Pan American Health Organization and relevant professional bodies shall be taken into account.

3.171. Registrants and licensees shall ensure that programmes of quality assurance for medical exposure include, as appropriate to the medical radiation facility:

(a) Measurements of the physical parameters of medical radiological equipment made by, or under the supervision of, a medical physicist:

(i) At the time of acceptance and commissioning of the equipment prior to its clinical use on patients;

(ii) Periodically thereafter;

(iii) After any major maintenanceprocedure that could affect protection and safety of patients;

(iv) After any installation of new software or modification of existing software that could affect protection and safety of patients.

(b) Implementation of corrective actions if measured values of the physical parameters mentioned in (a) above are outside established tolerance limits.

(c) Verification of the appropriate physical and clinical factors used in radiological procedures.

(d) Maintaining records of relevant procedures and results.

(e) Periodic checks of the calibration and conditions of operation of dosimetry equipment and monitoring equipment.

3.172. Registrants and licensees shall ensure that regular and independent audits are made of the programme of quality assurance for medical exposures, and that their frequency is in accordance with the complexity of the radiological procedures being performed and the associated risks.

Dose constraints

3.173. Registrants and licensees shall ensure that relevant dose constraints (para. 3.149(a)(i)) are used in the optimization of protection and safety in any radiological procedure in which an individual acts as a carer or comforter.

3.174. Registrants and licensees shall ensure that dose constraints specified or approved by the ethics committee (or other institutional body that has been assigned functions similar to those of an ethics committee by the relevant authority) on a case by case basis as part of a proposal for biomedical research (para. 3.161) are used in the optimization of protection and safety for persons subject to exposure as part of a programme of biomedical research.

See also:

SSG-46 Radiological Protection and Safety in Medical Uses of Ionizing Radiation
Requirement 39: Pregnant or breast-feeding female patients
Registrants and licensees shall ensure that there are arrangements in place for appropriate radiation protection in cases where a female patient is or might be pregnant or is breast-feeding.

3.175. Registrants and licensees shall ensure that signs in appropriate languages are placed in public places, waiting rooms for patients, cubicles and other appropriate places, and that other means of communication are also used as appropriate⁴⁶46, to request female patients who are to undergo a radiological procedure to notify the radiological medical practitioner, medical radiation technologist or other personnel in the event that:

She is or might be pregnant;

She is breast-feeding and the scheduled radiological procedure includes the administration of a radiopharmaceutical.

3.176. Registrants and licensees shall ensure that there are procedures in place for ascertaining the pregnancy status of a female patient of reproductive capacity before the performance of any radiological procedure that could result in a significant dose to the embryo or fetus, so that this information can be considered in the justification for the radiological procedure (paras 3.155 and 3.156) and in the optimization of protection and safety (para. 3.166).

3.177. Registrants and licensees shall ensure that there are arrangements in place for establishing that a female patient is not currently breast-feeding before the performance of any radiological procedure involving the administration of a radiopharmaceutical that could result in a significant dose to a breastfed infant, so that this information can be considered in the justification for the radiological procedure (paras 3.155 and 3.157) and in the optimization of protection and safety (para. 3.166).

See also:

SSG-46 Radiological Protection and Safety in Medical Uses of Ionizing Radiation
Requirement 40: Release of patients after radionuclide therapy
Registrants and licensees shall ensure that there are arrangements in place to ensure appropriate radiation protection for members of the public and for family members before a patient is released following radionuclide therapy.

3.178. The radiological medical practitioner shall ensure that no patient who has undergone a therapeutic radiological procedure with a sealed source or an unsealed source is discharged from a medical radiation facility until it has been established by either a medical physicist or the facility’s radiation protection officer that:

(a) The activity of radionuclides in the patient is such that doses that could be received by members of the public and family members would be in compliance with the requirements set by the relevant authorities (para. 3.149(b)); and

(b) The patient or the legal guardian of the patient is provided with:

(i) Written instructions for keeping doses to persons in contact with or in the vicinity of the patientas low as reasonably achievable and for avoiding the spread of contamination;

(ii) Information on the radiation risks.

See also:

SSG-46 Radiological Protection and Safety in Medical Uses of Ionizing Radiation
Requirement 41: Unintended and accidental medical exposures
Registrants and licensees shall ensure that all practicable measures are taken to minimize the likelihood of unintended or accidental medical exposures. Registrants and licensees shall promptly investigate unintended or accidental medical exposures and, if appropriate, shall implement corrective actions.

3.179. Registrants and licensees, in accordance with the relevant requirements of paras 2.51, 3.41–3.42 and 3.49–3.50, shall ensure that all practicable measures are taken to minimize the likelihood of unintended or accidental medical exposures arising from flaws in design and operational failures of medical radiological equipment, from failures of and errors in software, or as a result of human error.

Investigation of unintended and accidental medical exposures

3.180. Registrants and licensees shall promptly investigate any of the following unintended or accidental medical exposures:

Any medical treatment delivered to the wrong individual or to the wrong tissue or organ of the patient, or using the wrong radiopharmaceutical, or with an activity, a dose or dose fractionation differing substantially from (over or under) the values prescribed by the radiological medical practitioner, or that could lead to unduly severe secondary effects;

Any diagnostic radiological procedure or image guided interventional procedure in which the wrong individual or the wrong tissue or organ of the patient is subject to exposure;

Any exposure for diagnostic purposes that is substantially greater than was intended;

Any exposure arising from an image guided interventional procedure that is substantially greater than was intended;

Any inadvertent exposure of the embryo or fetus in the course of performing a radiological procedure;

Any failure of medical radiological equipment, failure of software or system failure, or accident, error, mishap or other unusual occurrence with the potential for subjecting the patient to a medical exposure that is substantially different from what was intended.

3.181. Registrants and licensees shall, with regard to any unintended or accidental medical exposures investigated as required in para. 3.180:

Calculate or estimate the doses received and the dose distribution within the patient;

Indicate the corrective actions required to prevent the recurrence of such an unintended or accidental medical exposure;

Implement all the corrective actions that are under their own responsibility;

Produce and keep, as soon as possible after the investigation or as otherwise required by the regulatory body, a written record that states the cause of the unintended or accidental medical exposure and includes the information specified in (a)–(c) above, as relevant, and any other information as required by the regulatory body; and for significant unintended or accidental medical exposures or as otherwise required by the regulatory body, submit this written record, as soon as possible, to the regulatory body, and to the relevant health authority if appropriate;

Ensure that the appropriate radiological medical practitioner informs the referring medical practitioner and the patient or the patient’s legal authorized representative of the unintended or accidental medical exposure.

See also:

SSG-46 Radiological Protection and Safety in Medical Uses of Ionizing Radiation
Requirement 42: Reviews and records
Registrants and licensees shall ensure that radiological reviews are performed periodically at medical radiation facilities and that records are maintained.

Radiological reviews

3.182. Registrants and licensees shall ensure that radiological reviews are performed periodically by the radiological medical practitioners at the medical radiation facility, in cooperation with the medical radiation technologists and the medical physicists. The radiological review shall include an investigation and critical review of the current practical application of the radiation protection principles of justification and optimization for the radiological procedures that are performed in the medical radiation facility.

Records

3.183. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following personnel records:

Records of any delegation of responsibilities by a principal party (as required in para. 3.154(f));

Records of training of personnel in radiation protection (as required in para. 3.150(b)).

3.184. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following records of calibration, dosimetry and quality assurance:

Records of the results of the calibrations and periodic checks of the relevant physical and clinical parameters selected during treatment of patients;

Records of dosimetry of patients, as required in para. 3.168;

Records of local assessments and reviews made with regard to diagnostic reference levels, as required in para. 3.169;

Records associated with the quality assurance programme, as required in para. 3.171(d).

3.185. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following records for medical exposure:

For diagnostic radiology, information necessary for retrospective assessment of doses, including the number of exposures and the duration of fluoroscopic radiological procedures;

For image guided interventional procedures, information necessary for retrospective assessment of doses, including the duration of the fluoroscopic component and the number of images acquired;

For nuclear medicine, the types of radiopharmaceutical administered and their activity;

For external beam radiation therapy or brachytherapy, a description of the planning target volume, the absorbed dose to the centre of the planning target volume, and the maximum and minimum absorbed doses delivered

to the planning target volume, or equivalent alternative information on absorbed doses to the planning target volume, and the absorbed doses to relevant tissues or organs as determined by the radiological medical practitioner; and in addition, for external beam radiation therapy, the dose fractionation and the overall treatment time;

Exposure records for volunteers subject to medical exposure as part of a programme of biomedical research;

Reports on investigations of unintended and accidental medical exposures (as required in para. 3.181(d)).

See also:

SSG-46 Radiological Protection and Safety in Medical Uses of Ionizing Radiation
4. Emergency Exposure Situations Scope
4.1. The requirements for emergency exposure situations established in Section 4 apply to activities undertaken in preparedness for and in response to a nuclear or radiological emergency.
Generic Requirements Requirement 43: Emergency management system
The government shall ensure that an integrated and coordinated emergencymanagement system is established and maintained.

4.2. The government shall ensure that an emergencymanagement system is established and maintained on the territories and within the jurisdiction of the State for the purposes of emergency response to protect human life, health and the environment in the event of a nuclear or radiological emergency.

4.3. The emergencymanagement system shall be designed to be commensurate with the results of a hazard assessment [15] and to enable an effective emergency response to reasonably foreseeable events (including very low probability events) in connection with facilities or activities.

4.4. The emergencymanagement system shall be integrated, to the extent practicable, into an all-hazards emergencymanagement system.

4.5. The emergencymanagement system shall provide for essential elements at the scene, and at the local, national and international level, as appropriate, including the following [15]:

Hazard assessment;

Development and exercising of emergency plans and emergency procedures;

Clear allocation of responsibilities to persons and organizations having roles in the arrangements for emergency preparedness and response;

Arrangements for efficient and effective cooperation and coordination among organizations;

Reliable communication, including public information;

Optimized protection strategies for the implementation and the termination of measures for the protection of members of the public who could be subject to exposure in an emergency, including relevant considerations for protection of the environment;

Arrangements for the protection of emergency workers;

Education and training, including training in radiation protection, of all persons involved in emergency response and exercising of emergency plans and emergency procedures;

Preparations for the transition from emergency exposure situation to existing exposure situation;

Arrangements for the medical response and the public health response in an emergency;

Provision for individual monitoring and environmental monitoring and for dose assessment;

Involvement of relevant parties and interested parties.

4.6. The government shall ensure the coordination of its emergency arrangements and capabilities with the relevant international emergency arrangements.

See also GSR Part 7 on Preparedness and Response for a Nuclear or Radioalogical Emergency

Relevant Safety guides:

GS-G-2.1 Arrangements for Preparedness for a Nuclear or Radiological Emergency

GSG-2 Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency

GSG-19 Monitoring for Protection of the Public and the Environment

SSG-44 Establishing the Infrastructure for Radiation Safety
Public Exposure Requirement 44: Preparedness and response for an emergency
The government shall ensure that protection strategies are developed, justified and optimized at the planning stage, and that emergency response is undertaken by their timely implementation.

4.7. The government shall ensure that protection strategies are developed, justified and optimized at the planning stage, by using scenarios based on the hazard assessment, for avoiding deterministic effects and reducing the likelihood of stochastic effects due to public exposure.

4.8. Development of a protection strategy shall include, but shall not be limited to, the following three successive steps:

A reference level expressed in terms of residual dose shall be set, typically an effective dose in the range of 20–100 mSv, that includes dose contributions via all exposure pathways. The protection strategy shall include planning for residual doses to be as low as reasonably achievable below the reference level, and the strategy shall be optimized.

On the basis of the outcome of the optimization of the protection strategy, using the reference level, generic criteria for particular protective actions and other response actions, expressed in terms of projected dose or of dose that has been received, shall be developed. If the numerical values of the generic criteria⁴⁷47 are exceeded, those protective actions and other response actions, either individually or in combination, shall be implemented.

Once the protection strategy has been optimized and a set of generic criteria has been developed, pre-established operational criteria for initiating the different parts of an emergency plan, primarily for the initial phase, shall be derived from the generic criteria. Operational criteria, such as on-scene conditions, operational intervention levels and emergency action levels, shall be expressed in terms of parameters or observable conditions. Arrangements shall be established in advance to revise these operational criteria, as appropriate, in an emergency, with account taken of the prevailing conditions as they evolve.

4.9. Each protective action shall be justified in the context of the protection strategy.

4.10. The government shall ensure that in making arrangements for emergency preparedness and response it is taken into consideration that emergencies are dynamic, that decisions taken early in the emergency response may influence subsequent actions, and that different geographical areas may have different prevailing conditions and there may be different requirements for the response.

4.11. The government shall ensure that the response in an emergency exposure situation is undertaken by the timely implementation of arrangements for emergency response, including but not limited to:

Promptly taking protective actions and other response actions to avoid severe deterministic effects on the basis of observed conditions and, if possible, before any exposure occurs. Dose levels required to be used as generic criteria for preventing severe deterministic effects are given in Table IV.1 of Schedule IV (p. 372);

Assessing the effectiveness of the protective actions and other response actions taken and modifying them as appropriate;

Comparing residual doses with the applicable reference level, giving priority to those groups for whom residual doses exceed the reference level;

Implementing further protection strategies as necessary, on the basis of prevailing conditions and available information.

See also GSR Part 7on Preparedness and Response for a Nuclear or Radioalogical Emergency

Relevant safety guides:

SSG-40 Predisposal Management of Radioactive Waste from Nuclear Power Plants and Research Reactors

SSG-85 Radiation Protection and Radioactive Waste Management in the Design and Operation of Research Reactors

SSG-8 Radiation Safety of Gamma, Electron and X ray Irradiation Facilities

SSG-11 Radiation Safety in Industrial Radiography

GS-G-2.1 Arrangements for Preparedness for a Nuclear or Radiological Emergency

GSG-2 Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency
Exposure of Emergency Workers Requirement 45: Arrangements for controlling the exposure of emergency workers
The government shall establish a programme for managing, controlling and recording the doses received in an emergency by emergency workers.

4.12. The government shall establish a programme for managing, controlling and recording the doses received in an emergency by emergency workers, which shall be implemented by response organizations and employers.

4.13. The response organization and employers responsible for ensuring compliance with the requirements in paras 4.14–4.19 shall be specified in the emergency plan.

4.14. In an emergency exposure situation, the relevant requirements for occupational exposure in planned exposure situations (paras 3.69–3.116) shall be applied for emergency workers, in accordance with a graded approach, except as required in para. 4.15.

4.15. Response organizations and employers shall ensure that no emergency worker is subject to an exposure in an emergency in excess of 50 mSv other than:

For the purposes of saving life or preventing serious injury;

When undertaking actions to prevent severe deterministic effects and actions to prevent the development of catastrophic conditions that could significantly affect people and the environment; or When undertaking actions to avert a large collective dose.

4.16. In the exceptional circumstances specified in para. 4.15, response organizations and employers shall make all reasonable efforts to keep doses to emergency workers below the values set out in Table IV.2 of Schedule IV (p. 373).

In addition, emergency workers undertaking actions as a result of which their doses could approach or exceed the values set out in Table IV.2 of Schedule IV shall do so only when the expected benefits to others would clearly outweigh the risks to the emergency workers.

4.17. Response organizations and employers shall ensure that emergency workers who undertake actions in which the doses received might exceed 50 mSv do so voluntarily⁴⁸48; that they have been clearly and comprehensively informed in advance of the associated health risks, as well as of available measures for protection and safety; and that they are, to the extent possible, trained in the actions that they may be required to take.

4.18. Response organizations and employers shall take all reasonable steps to assess and record the doses received in an emergency by emergency workers. Information on the doses received and information concerning the associated health risks shall be communicated to the workers involved.

4.19. Workers who receive doses in an emergency exposure situation shall not normally be precluded from incurring further occupational exposure. However, qualified medical advice shall be obtained before any further occupational exposure if such a worker has received a dose exceeding 200 mSv or at the request of the worker.

See also GSR Part 7on Preparedness and Response for a Nuclear or Radioalogical Emergency

Relevant Safety guides:

GSG-2 Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency

GSG-7 Occupational Radiation Protection
Transition from an Emergency Situation to an Existing Exposure Situation Requirement 46: Arrangements for the transition from an emergency exposure situation to an existing exposure situation
The government shall ensure that arrangements are in place and are implemented as appropriate for the transition from an emergency exposure situation to an existing exposure situation.

4.20. The government shall ensure that, as part of its overall emergency preparedness, arrangements are in place for the transition from an emergency exposure situation to an existing exposure situation. The arrangements shall take into account that different geographical areas may undergo the transition at different times. The responsible authority shall take the decision to make the transition to an existing exposure situation. The transition shall be made in a coordinated and orderly manner, by making any necessary transfer of responsibilities between organizations, with the involvement of relevant authorities and interested parties.

4.21. Workers undertaking work such as repairs to plant and buildings or activities for radioactive waste management, or undertaking remedial actions for the decontamination of the site and surrounding areas, shall be subject to the relevant requirements for occupational exposure in planned exposure situations stated in Section 3.

See also GSR Part 7on Preparedness and Response for a Nuclear or Radioalogical Emergency

GSG-11 Arrangements for the Termination of a Nuclear or Radiological Emergency
5. Existing Exposure Situations Scope
5.1. The requirements for existing exposure situations in Section 5 apply to:

(a) Exposure due to contamination of areas by residual radioactive material deriving from:

(i) Past activities that were never subject to regulatory control or that were subject to regulatory control but not in accordance with the requirements of these Standards;

(ii) A nuclear or radiological emergency, after an emergency has been declared to be ended (as required in para. 4.20).

(b) Exposure due to commodities, including food, feed, drinking water and construction materials, that incorporate radionuclides deriving from residual radioactive material as stated in para. 5.1(a).

(c) Exposure due to natural sources, including:

(i) ²²²Rn and its progeny and ²²⁰Rn and its progeny, in workplaces other than those workplaces for which exposure due to other radionuclides in the uranium decay chain or the thorium decay chain is controlled as a planned exposure situation, in dwellings and in other buildings with high occupancy factors for members of the public;

(ii) Radionuclides of natural origin, regardless of activity concentration, in commodities, including food, feed, drinking water, agricultural fertilizer and soil amendments, and construction materials, and residual radioactive material in the environment;

(iii) Materials, other than those stated in (c)(ii) above, in which the activity concentration of no radionuclide in either the uranium decay chain or the thorium decay chain exceeds 1 Bq/g and the activity concentration of ⁴⁰K does not exceed 10 Bq/g;

(iv) Exposure of aircrew and space crew to cosmic radiation.
Generic Requirements Requirement 47: Responsibilities of the government specific to existing exposure situations
The government shall ensure that existing exposure situations that have been identified are evaluated to determine which occupational exposures and public exposures are of concern from the point of view of radiation protection.

5.2. The government shall ensure that, when an existing exposure situation is identified, responsibilities for protection and safety are assigned and appropriate reference levels are established.

5.3. The government shall include in the legal and regulatory framework for protection and safety (see Section 2) provision for the management of existing exposure situations. The government, in the legal and regulatory framework, as appropriate:

Shall specify the exposure situations that are included in the scope of existing exposure situations;⁴⁹49

Shall specify the general principles underlying the protection strategies developed to reduce exposure when remedial actions and protective actions have been determined to be justified;⁵⁰50

Shall assign responsibilities for the establishment and implementation of protection strategies to the regulatory body and to other relevant authorities⁵¹51 and, as appropriate, to registrants, licensees and other parties involved in the implementation of remedial actions and protective actions;

Shall provide for the involvement of interested parties in decisions regarding the development and implementation of protection strategies, as appropriate.

5.4. The regulatory body or other relevant authority assigned to establish a protection strategy for an existing exposure situation shall ensure that it specifies:

The objectives to be achieved by means of the protection strategy;

Appropriate reference levels.

5.5. The regulatory body or other relevant authority shall implement the protection strategy, including:

Arranging for evaluation of the available remedial actions and protective actions for achieving the objectives, and for evaluation of the efficiency of the actions planned and implemented;

Ensuring that information is available to individuals subject to exposure on potential health risks and on the means available for reducing their exposures and the associated risks.

Relevant Safety guides:

GSG-15 Remediation Strategy and Process for Areas Affected by Past Activities or Events
Public Exposure Scope
5.6. The requirements in respect of public exposure in existing exposure situations (paras 5.7–5.23) apply to any public exposure arising from the situations specified in para. 5.1.
Requirement 48: Justification for protective actions and optimization of protection and safety
The government and the regulatory body or other relevant authority shall ensure that remedial actions and protective actions are justified and that protection and safety is optimized.

5.7. The government and the regulatory body or other relevant authority shall ensure that the protection strategy for the management of existing exposure situations, established in accordance with paras 5.2 and 5.4, is commensurate with the radiation risks associated with the existing exposure situation; and that remedial actions or protective actions are expected to yield sufficient benefits to outweigh the detriments associated with taking them, including detriments in the form of radiation risks.⁵²52

5.8. The regulatory body or other relevant authority and other parties responsible for remedial actions or protective actions shall ensure that the form, scale and duration of such actions are optimized. While this optimization process is intended to provide optimized protection for all individuals subject to exposure, priority shall be given to those groups for whom the dose exceeds the reference level. All reasonable steps shall be taken to prevent doses from remaining above the reference levels. Reference levels shall typically be expressed as an annual effective dose to the representative person in the range of 1–20 mSv or other corresponding quantity, the actual value depending on the feasibility of controlling the situation and on experience in managing similar situations in the past.

5.9. The regulatory body or other relevant authority shall periodically review the reference levels to ensure that they remain appropriate in the light of the prevailing circumstances.

Relevant Safety guides:

GSG-15 Remediation Strategy and Process for Areas Affected by Past Activities or Events
Requirement 49: Responsibilities for remediation of areas with residual radioactive material
The government shall ensure that provision is made for identifying those persons or organizations responsible for areas with residual radioactive material; for establishing and implementing remediation programmes and post-remediation control measures, if appropriate; and for putting in place an appropriate strategy for radioactive waste management.

5.10. For the remediation of areas with residual radioactive material deriving from past activities or from a nuclear or radiological emergency (para. 5.1(a)), the government shall ensure that provision is made in the framework for protection and safety for:

The identification of those persons or organizations responsible for the contamination of areas and those responsible for financing the remediation programme, and the determination of appropriate arrangements for alternative sources of funding if such persons or organizations are no longer present or are unable to meet their liabilities;

The designation of persons or organizations responsible for planning, implementing and verifying the results of remedial actions;

The establishment of any restrictions on the use of or access to the areas concerned before, during and, if necessary, after remediation;

An appropriate system for maintaining, retrieval and amendment of records that cover the nature and the extent of contamination; the decisions made before, during and after remediation; and information on verification of the results of remedial actions, including the results of all monitoring programmes after completion of the remedial actions.

5.11. The government shall ensure that a strategy for radioactive waste management is put in place to deal with any waste arising from the remedial actions and that provision for such a strategy is made in the framework for protection and safety.

5.12. The persons or organizations responsible for the planning, implementation and verification of remedial actions shall, as appropriate, ensure that:

(a) A remedial action plan, supported by a safety assessment, is prepared and is submitted to the regulatory body or other relevant authority for approval.

(b) The remedial action plan is aimed at the timely and progressive reduction of the radiation risks and eventually, if possible, at the removal of restrictions on the use of or access to the area.

(c) Any additional doses received by members of the public as a result of the remedial actions are justified on the basis of the resulting net benefit, including consideration of the consequent reduction of the annual dose.

(d) In the choice of the optimized remediation option:

(i) Radiological impacts on people and the environment are considered together with non-radiological impacts on people and the environment, and with technical, societal and economic factors;

(ii) The costs of the transport and management of radioactive waste, the radiation exposure of and health risks to the workers managing the radioactive waste, and any subsequent public exposure associated with its disposal are all taken into account.

(e) A mechanism for public information is in place and interested parties are involved in the planning, implementation and verification of the remedial actions, including any monitoring following remediation.

(f) A monitoring programme is established and implemented.

(g) A system for maintaining adequate records relating to the existing exposure situation and to actions taken for protection and safety is in place.

(h) Procedures are in place for reporting to the regulatory body or other relevant authority on any abnormal conditions relevant to protection and safety.

5.13. The regulatory body, in accordance with para. 2.29, or other relevant authority shall take responsibility, in particular for:

Review of the safety assessment submitted by the responsible person or organization, approval of the remedial action plan and of any subsequent changes to the remedial action plan, and granting of any necessary authorization;

Establishment of criteria and methods for assessing safety;

Review of work procedures, monitoring programmes and records;

Review and approval of significant changes to procedures or equipment that may have radiological environmental impacts or that may alter the exposure conditions for workers taking remedial actions or for members of the public;

Where necessary, establishment of regulatory requirements for control measures following remediation.

5.14. The person or organization responsible for carrying out the remedial actions:

Shall ensure that the work, including management of the radioactive waste arising, is conducted in accordance with the remedial action plan;

Shall take responsibility for all aspects of protection and safety, including the conduct of a safety assessment;

Shall monitor the area regularly during the remediation so as to verify levels of contamination, to verify compliance with the requirements for radioactive waste management, and to enable any unexpected levels of radiation to be detected and the remedial action plan to be modified accordingly, subject to approval by the regulatory body or other relevant authority;

Shall perform a radiological survey after completion of remedial actions to demonstrate that the end point conditions, as established in the remedial action plan, have been met;

Shall prepare and retain a final remediation report and shall submit a copy to the regulatory body or other relevant authority.

5.15. After the remedial actions have been completed, the regulatory body or other relevant authority:

(a) Shall review, amend as necessary and formalize the type, extent and duration of any post-remediation control measures already identified in the remedial action plan, with due consideration of the residual radiation risks.

(b) Shall identify the person or organization responsible for any post-remediation control measures.

(c) Shall, where necessary, impose specific restrictions for the remediated area to control:

(i) Access by unauthorized persons;

(ii) Removal of radioactive material or use of such material, including its use in commodities;

(iii) Future use of the area, including the use of water resources and its use for the production of food or feed, and the consumption of food from the area.

(d) Shall periodically review conditions in the remediated area and, if appropriate, shall amend or remove any restrictions.

5.16. The person or organization responsible for post-remediation control measures shall establish and maintain, for as long as required by the regulatory body or other relevant authority, an appropriate programme, including any necessary provision for monitoring, to verify the long term effectiveness of the completed remedial actions for areas in which controls are required after remediation.

5.17. For those areas with long lasting residual radioactive material, in which the government has decided to allow habitation and the resumption of social and economic activities, the government, in consultation with interested parties, shall ensure that arrangements are in place, as necessary, for the continuing control of exposure with the aim of establishing conditions for sustainable living, including:

Establishment of reference levels for protection and safety that are consistent with day to day life;

Establishment of an infrastructure to support continuing ‘self-help protective actions’ in the affected areas, such as by the provision of information and advice, and by monitoring.

5.18. The conditions prevailing after the completion of remedial actions, if the regulatory body or other relevant authority has imposed no restrictions or controls, shall be considered to constitute the background conditions for any new facilities and activities or for habitation on the land.

Relevant Safety guides:

GSG-15 Remediation Strategy and Process for Areas Affected by Past Activities or Events

GSG-19 Monitoring for Protection of the Public and the Environment
Requirement 50: Public exposure due to radon indoors
The government shall provide information on levels of radon indoors and the associated health risks and, if appropriate, shall establish and implement an action plan for controlling public exposure due to radon indoors.

5.19. As part of its responsibilities, as required in para. 5.3, the government shall ensure that:

Information is gathered on activity concentrations of radon in dwellings and other buildings with high occupancy factors for members of the public⁵³53 through appropriate means, such as representative radon surveys;

Relevant information on exposure due to radon and the associated health risks, including the increased risks relating to smoking, is provided to the public and other interested parties.

5.20. Where activity concentrations of radon that are of concern for public health are identified on the basis of the information gathered as required in para. 5.19(a), the government shall ensure that an action plan is established comprising coordinated actions to reduce activity concentrations of radon in existing buildings and in future buildings, which includes⁵⁴54:

Establishing an appropriate reference level for ²²²Rn for dwellings and other buildings with high occupancy factors for members of the public, with account taken of the prevailing social and economic circumstances, that in general will not exceed an annual average activity concentration due to ²²²Rn of 300 Bq/m³⁵⁵55;

Reducing activity concentrations of ²²²Rn and consequent exposures to levels at which protection is optimized;

Giving priority to actions to reduce activity concentrations of ²²²Rn in those situations for which such action is likely to be most effective⁵⁶56;

Including in building codes appropriate preventive measures and corrective actions to prevent the ingress of ²²²Rn and to facilitate further actions wherever necessary.

5.21. The government shall assign responsibility for:

Establishing and implementing the action plan for controllingpublic exposure due to ²²²Rn indoors;

Determining the circumstances under which actions are to be mandatory or are to be voluntary, with account taken of legal requirements and of the prevailing social and economic circumstances.

Relevant Safety guides:

SSG-32 Protection of the Public against Exposure Indoors due to Radon and Other Natural Sources of Radiation

You may also wish to read:

IAEA-TECDOC-1951, Protection against Exposure Due to Radon Indoors and Gamma Radiation from Construction Materials — Methods of Prevention and Mitigation

IAEA Safety Report Series No. 98, Design and Conduct of Indoor Radon Surveys
Requirement 51: Exposure due to radionuclides in commodities
The regulatory body or other relevant authority shall establish reference levels for exposure due to radionuclides in commodities.

5.22. The regulatory body or other relevant authority shall establish specific reference levels for exposure due to radionuclides in commodities such as construction materials, food and feed, and in drinking water, each of which shall typically be expressed as, or be based on, an annual effective dose to the representative person that generally does not exceed a value of about 1 mSv.

5.23. The regulatory body or other relevant authority shall consider the guideline levels for radionuclides in food traded internationally that could contain radioactive substances as a result of a nuclear or radiological emergency, which have been published by the Joint Food and Agriculture Organization of the United Nations/World Health Organization Codex Alimentarius Commission [23]. The regulatory body or other relevant authority shall consider the guideline levels for radionuclides contained in drinking water that have been published by the World Health Organization [24].

Relevant safety guides:

GSG-17 Application of the Concept of Exemption

GSG-18 Application of the Concept of Clearance

SSG-32 Protection of the Public against Exposure Indoors due to Radon and Other Natural Sources of Radiation

You may also wish to read:

IAEA-TECDOC-2011 Exposure Due to Radionuclides in Food Other Than During a Nuclear or Radiological Emergency

IAEA-TECDOC-1788 Criteria for Radionuclide Activity Concentrations for Food and Drinking Water

Safety Report Series No. 114 Exposure due to Radionuclides in Food Other then During a Nuclear or Radiological Emergency, Part 1: Technical Material

Safety Report Series No. 117 Regulatort Control of Exposure due to Radionuclides in Building Materials and Construction Materials
Occupational Exposure Scope
5.24. The requirements in respect of occupational exposure in existing exposure situations (paras 5.25–5.33) apply to any occupational exposure arising from the situations specified in para. 5.1.
Requirement 52: Exposure in workplaces
The regulatory body shall establish and enforce requirements for the protection of workers in existing exposure situations.

5.25. The requirements in respect of public exposure stated in paras 5.7–5.9 shall be applied for protection and safety for workers in existing exposure situations, other than in those specific situations identified in paras 5.26–5.33.

Remediation of areas with residual radioactive material

5.26. Employers shall ensure that the exposure of workers undertaking remedial actions is controlled in accordance with the relevant requirements on occupational exposure in planned exposure situations as established in Section 3.

Exposure due to radon in workplaces

5.27. The regulatory body or other relevant authority shall establish a strategy for protection against exposure due to ²²²Rn in workplaces, including the establishment of an appropriate reference level for ²²²Rn. The reference level for ²²²Rn shall be set at a value that does not exceed an annual average activity concentration of ²²²Rn of 1000 Bq/m³, with account taken of the prevailing social and economic circumstances.⁵⁷57 5.28. Employers shall ensure that activity concentrations of ²²²Rn in workplaces are as low as reasonably achievable below the reference level established in accordance with para. 5.27, and shall ensure that protection is optimized.

5.29. If, despite all reasonable efforts by the employer to reduce activity concentrations of radon, the activity concentration of ²²²Rn in workplaces remains above the reference level established in accordance with para. 5.27, the relevant requirements for occupational exposure in planned exposure situations as stated in Section 3 shall apply.

Exposure of aircrew and space crew due to cosmic radiation

5.30. The regulatory body or other relevant authority shall determine whether assessment of the exposure of aircrew due to cosmic radiation is warranted.

5.31. Where such assessment is deemed to be warranted, the regulatory body or other relevant authority shall establish a framework which shall include a reference level of dose and a methodology for the assessment and recording of doses received by aircrew from occupational exposure to cosmic radiation.

5.32. In accordance with para. 5.31:

(a) Where the doses of aircrew are likely to exceed the reference level, employers of aircrew:

(i) Shall assess and keep records of doses;

(ii) Shall make records of doses available to aircrew.

(b) Employers:

(i) Shall inform female aircrew of the risk to the embryo or fetus due to exposure to cosmic radiation and of the need for early notification of pregnancy;

(ii) Shall apply the requirements of para. 3.114 in respect of notification of pregnancy.

5.33. The regulatory body or other relevant authority shall establish, where appropriate, a framework for radiation protection that applies to individuals in space based activities that is appropriate for the exceptional conditions of space.

While the requirements of these Standards in respect of dose limits do not apply to individuals in space based activities, all reasonable efforts shall be made to optimize protection for individuals in space based activities by restricting the doses received by such individuals while not unduly limiting the extent of such activities.

Relevant Safety guides:

SSG-32 Protection of the Public against Exposure Indoors due to Radon and Other Natural Sources of Radiation

GSG-7 Occupational Radiation Protection

You may also wish to read:

Safety Report Series No. 100 Occupational Radiation Protection in the Uranium Mining and Processing Industry

Appendix I - Schedule I : Exemption and Clearance
Criteria for Exemption
I.1. The general criteria for exemption of a practice or a source within a practice from some or all of the requirements of these Standards are that:

Radiation risks arising from the practice or from a source within the practice are sufficiently low as not to warrant regulatory control, with no appreciable likelihood of situations arising that could lead to a failure to meet the general criterion for exemption; or

Regulatory control of the practice or the source would yield no net benefit, in that no reasonable measures for regulatory control would achieve a worthwhile return in terms of reduction of individual doses or of health risks.

I.2. A practice or a source within a practice may be exempted without further consideration from some or all of the requirements of these Standards under the terms of para. I.1(a) provided that under all reasonably foreseeable circumstances the effective dose expected to be incurred by any individual (normally evaluated on the basis of a safety assessment) owing to the exempt practice or the exempt source within the practice is of the order of 10 μSv or less in a year. To take into account low probability scenarios, a different criterion could be used, namely that the effective dose expected to be incurred by any individual for such low probability scenarios does not exceed 1 mSv in a year.

I.3. Under the criteria set out in paras I.1 and I.2, the following sources within justified practices are automatically exempted without further consideration from the requirements of these Standards, including requirements for notification, registration or licensing:

Material in a moderate amount⁵⁸58 for which either the total activity of an individual radionuclide present on the premises at any one time or the activity concentration as used in the practice does not exceed the applicable exemption level given in Table I.1 (p. 111)⁵⁹59.

Material in bulk amount⁵⁸ for which the activity concentration of a given radionuclide of artificial origin used in the practice does not exceed the relevant value given in Table I.2 (p. 124)⁵⁹.

Radiation generators of a type approved by the regulatory body, or in the form of an electronic tube, such as a cathode ray tube for the display of visual images, provided that:

They do not in normal operating conditions cause an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding 1 μSv/h at a distance of 0.1 m from any accessible surface of the equipment; or

The maximum energy of the radiation generated is no greater than 5 keV.

I.4. For radionuclides of natural origin, exemption of bulk amounts of material is necessarily considered on a case by case basis⁶⁰60 by using a dose criterion of the order of 1 mSv in a year, commensurate with typical doses due to natural background levels of radiation.

I.5. The IAEA Regulations for the Safe Transport of Radioactive Material [12] (the IAEA Transport Regulations) do not apply to exempt material or exempt consignments; that is, they do not apply to material in transport for which the activity concentration of the material (for exempt material) or the total activity of radionuclides in the consignment (for an exempt consignment) does not exceed the relevant ‘basic radionuclide value’ given in the IAEA Transport Regulations for exemption from the requirements of the IAEA Transport Regulations⁶¹61. Usually, such basic radionuclide values are numerically equal to the corresponding exempt activity concentrations or exempt activities given in Table I.1 (p. 111).

I.6. Exemptions may be granted subject to conditions specified by the regulatory body, such as conditions relating to the physical or chemical form of the radioactive material, and to its use or the means of its disposal. In particular, such an exemption may be granted for equipment containing radioactive material that is not otherwise automatically exempted without further consideration from some or all of the requirements of these Standards under para. I.3(a) provided that:

The equipment containing radioactive material is of a type approved by the regulatory body.

The radioactive material:

Is in the form of a sealed source that effectively prevents any contact with the radioactive material and prevents its leakage; or

Is in the form of an unsealed source in a small amount such as sources used for radioimmunoassay.

In normal operating conditions, the equipment does not cause an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding 1 μSv/h at a distance of 0.1 m from any accessible surface of the equipment.

Necessary conditions for disposal of the equipment have been specified by the regulatory body.

I.7. For exemption of radioactive material containing more than one radionuclide, on the basis of the levels given in Tables I.1 (p. 111) and I.2 (p. 124), the condition for exemption from some or all of the requirements of these Standards is that the sum of the individual radionuclide activities or activity concentrations, as appropriate, is less than the derived exemption level for the mixture (X_m), determined as follows:

(I.1)

where

f(i) is the fraction of activity or activity concentration, as appropriate, of radionuclide i in the mixture;

X(i) is the applicable level for radionuclide i as given in Table I.1 (p. 111) or Table I.2 (p. 124);

and n is the number of radionuclides present.

I.8. Radioactive material arising from authorized discharges is exempt from any requirements for notification, registration or licensing unless otherwise specified by the regulatory body.

I.9. The values provided in Tables I.1 and I.2 are not intended to be applied to the control of discharges or to the control of residual radioactive material in the environment.
Criteria for Clearance
I.10. The general criteria for clearance are that:

Radiation risks arising from the cleared material are sufficiently low as not to warrant regulatory control, and there is no appreciable likelihood of occurrence for scenarios that could lead to a failure to meet the general criterion for clearance; or

Continued regulatory control of the material would yield no net benefit, in that no reasonable control measures would achieve a worthwhile return in terms of reduction of individual doses or reduction of health risks.

I.11. Material may be cleared without further consideration under the terms of para. I.10(a) provided that in reasonably foreseeable circumstances the effective dose expected to be incurred by any individual owing to the cleared material is of the order of 10 μSv or less in a year. To take into account low probability scenarios, a different criterion can be used, namely that the effective dose expected to be incurred by any individual for such low probability scenarios does not exceed 1 mSv in a year.

I.12. Radioactive material within a notified practice or an authorized practice may be cleared without further consideration provided that:

The activity concentration of an individual radionuclide of artificial origin in solid form does not exceed the relevant level given in Table I.2 (p. 124)⁶²62; or

The activity concentrations of radionuclides of natural origin do not exceed the relevant level given in Table I.3 (p. 128)⁶³63; or

For radionuclides of natural origin in residues that might be recycled into construction materials⁶⁴64, or the disposal of which is liable to cause the contamination of drinking water supplies, the activity concentration in the residues does not exceed specific values derived so as to meet a dose criterion of the order of 1 mSv in a year, which is commensurate with typical doses due to natural background levels of radiation.

I.13. Clearance may be granted by the regulatory body for specific situations, on the basis of the criteria of paras I.10 and I.11, with account taken of the physical or chemical form of the radioactive material, and its use or the means of its disposal⁶⁵65. Such clearance levels may be specified in terms of activity concentration per unit mass or activity concentration per unit surface area.

I.14. For clearance of radioactive material containing more than one radionuclide of artificial origin, on the basis of the levels given in Table I.2 (p. 124), the condition for clearance is that the sum of the activity concentrations for individual radionuclides is less than the derived clearance level for the mixture (Xm), determined as follows:

(I.2)

where

where f(i) is the fraction of activity concentration of radionuclide i in the mixture;

X(i) is the applicable level for radionuclide i as given in Table I.2;

and n is the number of radionuclides present.

I.15. For clearance of bulk quantities of material containing a mixture of radionuclides of natural origin and radionuclides of artificial origin, the conditions given in paras I.12(b) and I.14 both have to be satisfied.

See the Table I.1. here, pages 111 to 123

See the Table I.2. here, pages 124 to 128

See the Table I.3. here, page 128

Appendix II - Schedule II: Categories for sealed sources used in common practices

II.1. Table II.1 shows categories for sealed sources used in common practices, and Table II.2 shows the activity corresponding to a dangerous source (D value) for selected radionuclides.

Table II.1. Categories for sealed sources used in common practices .

Category

Ratio of activity in the source to activity that is considered dangerous^a (A/D)

Example of sources^b and practices

1

Radioisotope thermoelectric generators;

Irradiators;

Teletherapy sources;

Fixed, multibeam teletherapy (‘gamma knife’) sources

2

Industrial gamma radiography sources;

High/medium dose rate brachytherapy sources

3

Fixed industrial gauges incorporating

high activitysources;

Well logging gauges

Low dose rate brachytherapy sources

(except eye plaques and permanent implants);

4

Industrial gauges not incorporating high

activity sources;

Bone densitometers;

Static eliminators

5

and level for exemption^c

Low dose rate brachytherapy eye plaques and

permanent implant sources;

X ray fluorescence devices;

Electron capture devices;

Mossbauer spectrometry sources;

Positron emission tomography check sources

^a A is the activity of the radionuclide in a source and D is the activity of that radionuclide that is regarded as dangerous. A dangerous source is defined as one that could, if not under control, give rise to exposure sufficient to causesevere deterministic effects. Values of D for selected radionuclides are given in Table II.2 on the basis of the quantity of radioactive material that could give rise to severe deterministic effects for given exposurescenarios and for given dose criteria. This column of the table can, thus, be used to determine the category of a source, purely on the basis of the value of A/D. This may be appropriate if, for example: the practice is not known or is not listed; if sources have a short half-life and/or are unsealed; or if sources are aggregated.

^b Factors other than A/D have been taken into consideration in assigning these sources to a particular category [28].

^c Levels for exemption are given in Schedule I.

Table II.2. Activity ^a corresponding to a dangerous source ( D value ^b ) for selected radionuclides

Radionuclide

D value (TBq)

Am-241

6 x 10^-2

Am-241/Be

6 x 10^-2

Au-198

2 x 10^-1

Cd-109

2 x 10¹

Cf-252

2 x 10^-2

Cm-244

5 x 10^-2

Co-57

7 x 10^-1

Co-60

3 x 10^-2

Cs-137

1 x 10^-1

Fe-55

8 x 10²

Gd-153

1 x 10⁰

Ge-68

7 x 10^-2

H-3

2 x 10³

I-125

2 x 10^-1

I-131

2 x 10^-1

Ir-192

8 x 10^-2

Kr-85

3 x 10¹

Mo-99

3 x 10^-1

Ni-63

3 x 10^-1

P-32

6 x 10¹

Pd-103

9 x 10¹

Pm-147

4 x 10¹

Po-210

6 x 10^-2

Pu-238

6 x 10^-2

Pu-239/Be

6 x 10^-2

Ra-226

4 x 10^-2

Ru-106 (Rh-106)

3 x 10^-1

Se-75

2 x 10^-1

Sr-90 (Y-90)

1 x 10⁰

Tc-99m

7 x 10^-1

Tl-204

2 x 10¹

Tm-170

2 x 10¹

Yb-169

3 x 10^-1

^a Since this table does not state which dose criteria were used, these D values cannot be used ‘in reverse’ to derive possible doses from exposure due to sources of known activity.

^b Full details of the derivation of the D values and D values for additional radionuclides are provided in Ref. [29].

Appendix III - Schedule III: Dose limits for planned exposure situations
Occupational exposure
III.1. For occupational exposure of workers over the age of 18 years, the dose limits are:

An effective dose of 20 mSv per year averaged over five consecutive years⁶⁶66 (100 mSv in 5 years) and of 50 mSv in any single year;

An equivalent dose to the lens of the eye of 20 mSv per year averaged over five consecutive years (100 mSv in 5 years) and of 50 mSv in any single year;

An equivalent dose to the extremities (hands and feet) or to the skin⁶⁷67 of 500 mSv in a year.

Additional restrictions apply to occupational exposure for a female worker who has notified pregnancy or is breast-feeding (para. 3.114).

III.2. For occupational exposure of apprentices of 16 to 18 years of age who are being trained for employment involving radiation and for exposure of students of age 16 to 18 who use sources in the course of their studies, the dose limits are:

An effective dose of 6 mSv in a year;

An equivalent dose to the lens of the eye of 20 mSv in a year;

An equivalent dose to the extremities (hands and feet) or to the skin⁶⁷ of 150 mSv in a year.

Public exposure
III.3. For public exposure, the dose limits are:

An effective dose of 1 mSv in a year;

In special circumstances⁶⁸68, a higher value of effective dose in a single year could apply, provided that the average effective dose over five consecutive years does not exceed 1 mSv per year;

An equivalent dose to the lens of the eye of 15 mSv in a year;

An equivalent dose to the skin of 50 mSv in a year.

Verification of compliance with dose limits
III.4. The effective doselimits specified in this schedule apply to the sum of the relevant doses from external exposure in the specified period and the relevant committed doses from intakes in the same period; the period for calculating the committed dose shall normally be 50 years for intakes by adults and shall be up to age 70 years for intakes by children.

III.5. For occupational exposure, the personal dose equivalentHp(10)⁶⁹69 may be used as an approximation of the effective dose from external exposure to penetrating radiation.

III.6. Values of the effective dose per unit air kerma free-in-air and per unit particle fluence are given in Tables III.1A–III.1D [30].

III.7. Doses per unit intake (dose coefficients) for the estimation of the committed effective dose for ingestion and inhalation of radionuclides are given in Tables III.2A–III.2H (p. 137) [37, 38].

See the Table III.1.A. here, page 134

See the Table III.1.B. here, page 134

See the Table III.1.C. here, page 135

See the Table III.1.D. here, page 136

See the Table III.2.A. here, pages 137 to 207

See the Table III.2.B. here, pages 208 to 211

See the Table III.2.C. here, pages 212 to 223

See the Table III.2.D. here, pages 224 to 268

See the Table III.2.E. here, pages 269 to 357

See the Table III.2.F. here, pages 358 to 361

See the Table III.2.G. here, pages 362 to 369

See the Table III.2.H. here, page 370

Appendix IV - Schedule IV: Criteria for use in emergency preparedness and response

IV.1. Table IV.1 gives generic criteria for doses received within a short period of time for which protective actions and other response actions are expected to be undertaken under any circumstances to avoid or to minimize severe deterministic effects.

IV.2. Table IV.2 gives guidance values for restricting exposure of emergency workers.
TABLE IV.1. GENERIC CRITERIA FOR DOSES RECEIVED WITHIN A SHORT PERIOD OF TIME FOR WHICH PROTECTIVE ACTIONS AND OTHER RESPONSE ACTIONS ARE EXPECTED TO BE UNDERTAKEN UNDER ANY CIRCUMSTANCES TO AVOID OR TO MINIMIZE SEVERE DETERMINISTIC EFFECTS

Acute external exposure (<10 h)

AD _{red marrow}^a

1 Gy

If the dose is projected:

- Take precautionary urgent protective actions immediately (even under difficult conditions) to keep doses below the generic criteria

- Provide public information and warnings

- Carry out urgent decontamination

AD _fetus

0.1 Gy

AD _tissue^b

25 Gy at 0.5 cm

AD _skin^c

10 Gy to 100 cm²

Acute internal exposure due to an acute intake

(Δ = 30 d)^d

AD(Δ)_{red marrow}

0.2 Gy for radionuclides with atomic number Z ≥ 90^e

2 Gy for radionuclides with atomic number Z ≤ 89^e

If the dose has been received:

- Perform immediate medical examination, consultation and indicated medical treatment

- Carry out contaminationcontrol

- Carry out immediate decorporationf (if applicable)

- Carry out registration for longer term medical follow-up

- Provide comprehensive psychological counselling

AD(Δ)_thyroid

2 Gy

AD(Δ)_lung^g

30 Gy

AD(Δ)_colon

20 Gy

AD(Δ′)_fetus^h

0.1 Gy

^a AD_{red marrow} represents the average relative biological effectiveness (RBE) weighted absorbed dose to internal tissues or organs (e.g. red marrow, lung, small intestine, gonads, thyroid) and to the lens of the eye from exposure in a uniform field of strongly penetrating radiation.

^b Dose delivered to 100 cm² at a depth of 0.5 cm under the body surface in tissue due to close contact with a radioactive source (e.g. source carried in the hand or pocket).

^c The dose is to the 100 cm² dermis (skin structures at a depth of 40 mg/cm² (or 0.4 mm) below the surface).

^d AD(Δ) is the RBE weighted absorbed dose delivered over a period of time Δ by the intake (I₀₅) that will result in a severe deterministic effect in 5% of exposed individuals. This dose is calculated as described in appendix I of Ref. [29].

^e Different generic criteria are used to take account of the significant difference in RBE weighted absorbed dose from exposure at the intake threshold values specific for these two groups of radionuclides.

^f Decorporation is the action of the biological processes, facilitated by chemical or biological agents, by means of which incorporated radionuclides are removed from the human body. The generic criterion for decorporation is based on the projected dose without decorporation.

^g For the purposes of these generic criteria, ‘lung’ means the alveolar-interstitial region of the respiratory tract.

^h For this particular case, ‘Δ′’ means the period of in utero development of the embryo and fetus.
TABLE IV.2. GUIDANCE VALUES FOR RESTRICTING EXPOSURE OF EMERGENCY WORKERS

Tasks

Guidance value^a

Life saving actions

Hp(10)^b < 500 mSv

This value may be exceeded under circumstances in which the expected benefits to others clearly outweigh the emergency worker’s own health risks, and the emergency worker volunteers to take the action and understands and accepts these health risks

Actions to prevent severe deterministic effects and actions to prevent the development of catastrophic conditions that could significantly affect people and the environment

Hp(10) < 500 mSv

Actions to avert a large collective dose

Hp(10) < 100 mSv

^a These values apply only for the dose from external exposure to strongly penetrating radiation. Doses from external exposure to weakly penetrating radiation and from intake or skin contamination need to be prevented by all possible means. If this is not feasible, the effective dose and the equivalent dose to a tissue or organ that are received have to be limited to minimize the health risk to the individual in line with the risk associated with the guidance values given here.

^b Hp(10) is the personal dose equivalentHp(d) where d = 10 mm.
References
References are to editions that are current as of the time of publication of these Standards. New editions that supersede these editions may be adopted under national legislation. In the event that the publications referenced here are superseded, please refer to the most recent editions. See also: http://www-ns.iaea.org/standards/

EUROPEAN ATOMIC ENERGY COMMUNITY, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANIZATION, INTERNATIONAL MARITIME ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, IAEA, Vienna (2006).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, The 2007 Recommendations of the International Commission on Radiological Protection, Publication 103, Elsevier (2007).

UNITED NATIONS, Effects of Ionizing Radiation. Vol. I: Report to the General Assembly, Scientific Annexes A and B; Vol. II: Scientific Annexes C, D and E, United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), UNSCEAR 2006 Report, E.08.IX.6 (2008) and E.09.IX.5 (2009), UN, New York.

UNITED NATIONS, Sources and Effects of Ionizing Radiation (Report to the General Assembly), Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), UN, New York (2000).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Lung Cancer Risk from Radon and Progeny and Statement on Radon, ICRP Publication 115, Elsevier (2010).

WORLD HEALTH ORGANIZATION, WHO Handbook on Indoor Radon: A Public Health Perspective, WHO, Geneva (2009).

INTERNATIONAL COMMISSION ON RADIATION UNITS AND MEASUREMENTS, Quantities and Units in Radiation Protection Dosimetry (Report 51), ICRU, Bethesda, MD (1993).

INTERNATIONAL ATOMIC ENERGY AGENCY, Governmental, Legal and Regulatory Framework for Safety, IAEA Safety Standards Series No. GSR Part 1, IAEA, Vienna (2010).

INTERNATIONAL ATOMIC ENERGY AGENCY, Decommissioning of Facilities, IAEA Safety Standards Series No. GSR Part 6, IAEA, Vienna (2014).

INTERNATIONAL ATOMIC ENERGY AGENCY, Predisposal Management of Radioactive Waste, IAEA Safety Standards Series No. GSR Part 5, IAEA, Vienna (2009).

INTERNATIONAL ATOMIC ENERGY AGENCY, Disposal of Radioactive Waste, IAEA Safety Standards Series No. SSR-5, IAEA, Vienna (2011).

INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material, 2012 Edition, IAEA Safety Standards Series No. SSR-6, IAEA, Vienna (2012).

INTERNATIONAL ATOMIC ENERGY AGENCY, The Management System for Facilities and Activities, IAEA Safety Standards Series No. GS-R-3, IAEA, Vienna (2006).

INTERNATIONAL ATOMIC ENERGY AGENCY, Safety Assessment for Facilities and Activities, IAEA Safety Standards Series No. GSR Part 4, IAEA, Vienna (2009).

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS OFFICE FOR THE CO-ORDINATION OF HUMANITARIAN AFFAIRS, WORLD HEALTH ORGANIZATION, Preparedness and Response for a Nuclear or Radiological Emergency, IAEA Safety Standards Series No. GS-R-2, IAEA, Vienna (2002).

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Basic Ionizing Radiation Symbol, ISO 361, ISO, Geneva (1975).

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Ionizing-radiation Warning — Supplementary Symbol, ISO 21482, ISO, Geneva (2007).

Council Directive 96/29 Euratom of 13 May 1996, Laying Down Basic Safety Standards for the Protection of Health of Workers and the General Public against the Dangers Arising from Ionizing Radiation, Official Journal of the European Communities No. L 159, Office for Official Publications of the European Communities, Luxembourg (1996).

INTERNATIONAL LABOUR ORGANIZATION, Technical and Ethical Guidelines for Workers’ Health Surveillance; Occupational Safety and Health Series 72, ILO, Geneva (1998).

WORLD MEDICAL ASSOCIATION, 18th World Medical Assembly, Helsinki, 1974, as amended by the 59th World Medical Assembly, Seoul, 2008.

COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES, WORLD HEALTH ORGANIZATION, International Ethical Guidelines for Biomedical Research Involving Human Subjects, CIOMS, Geneva (2002).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Radiological Protection in Biomedical Research, ICRP Publication 62, Pergamon Press, Oxford and New York (1991).

JOINT FAO/WHO FOOD STANDARDS PROGRAMME, CODEX ALIMENTARIUS COMMISSION, Codex General Standard for Contaminants and Toxins in Foods, Schedule 1 — Radionuclides, CODEX STAN 193-1995, CAC, Rome (2006).

WORLD HEALTH ORGANIZATION, Guidelines for Drinking-water Quality — 4th edn, WHO, Geneva (2011).

EUROPEAN COMMISSION, Principles and Methods for Establishing Concentrations and Quantities (Exemption Values) below which Reporting Is not Required in the European Directive, Radiation Protection 65, Office for Official Publications of the European Communities, Luxembourg (1993).

NATIONAL RADIOLOGICAL PROTECTION BOARD, Exempt Concentrations and Quantities for Radionuclides not Included in the European Basic Safety Standards Directive (MOBBS, S.F., HARVEY, M.P.), NRPB–R306, Chilton (1998).

INTERNATIONAL ATOMIC ENERGY AGENCY, Derivation of Activity Concentration Values for Exclusion, Exemption and Clearance, Safety Reports Series No. 44, IAEA, Vienna (2005).

INTERNATIONAL ATOMIC ENERGY AGENCY, Categorization of Radioactive Sources, IAEA Safety Standards Series No. RS-G-1.9, IAEA, Vienna (2005).

INTERNATIONAL ATOMIC ENERGY AGENCY, Dangerous Quantities of Radioactive Material (D-values), Emergency Preparedness and Response, EPR-D-VALUES 2006, IAEA, Vienna (2006).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Conversion Coefficients for Use in Radiological Protection against External Radiation, ICRP Publication 74, Pergamon Press, Oxford and New York (1997).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Age-dependent Doses to Members of the Public from Intake of Radionuclides — Part 1, Publication 56, Pergamon Press, Oxford and New York (1990).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Age-dependent Doses to Members of the Public from Intake of Radionuclides — Part 2 Ingestion Dose Coefficients, Publication 67, Pergamon Press, Oxford and New York (1992).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Age-dependent Doses to Members of the Public from Intake of Radionuclides — Part 4 Inhalation Dose Coefficients, Publication 71, Pergamon Press, Oxford and New York (1995).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Limits for Intakes of Radionuclides by Workers, Publication 30 (Suppl. B to Part 3), Pergamon Press, Oxford and New York (1982).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Age-dependent Doses to Members of the Public from Intake of Radionuclides — Part 3 Ingestion Dose Coefficients, Publication 69, Pergamon Press, Oxford and New York (1995).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Dose Coefficients for Intakes of Radionuclides by Workers, Publication 68, Pergamon Press, Oxford and New York (1994).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Compendium of Dose Coefficients Based on ICRP Publication 60, ICRP Publication 119, Elsevier (2012).

INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Individual Monitoring for Internal Exposure of Workers, Publication 78, Pergamon Press, Oxford and New York (1998).

[8] GSR Part 1 is now revised and issued as GSR Part 1 (Rev .1) Governmental, Legal and Regulatory Framework for Safety

[12] SSR-6 has been revised twice and is now superseded by SSR-6 (Rev. 2) Regulations for the Safe Transport of Radioactive Material, 2025 Edition

[13] GS-R-3 is now superseded by GSR Part 2 on Leadership and Management for Safety

[14] GSR Part 4 is now revised and issued as GSR Part 4 (Rev. 1) Safety Assessment of Facilities and Activities

[15] GS-R-2 is now superseded by GSR Part 7 on Preparedness and Response for a Nuclear or Radiological Emergency

Annex I - Generic criteria for protective actions and other response actions to reduce the risk of stochastic effects

A-1. Table A–1 provides a set of generic criteria (expressed in terms of projected dose and dose that has been received) for use in the protection strategy that are compatible with reference levels (expressed in terms of residual dose) within a range of 20–100 mSv, and provides details of specific protective actions and other response actions in different time frames.

A-2. For the thyroid, iodine thyroid blocking is an urgent protective action that is prescribed: (i) if exposure due to radioactive iodine is involved, (ii) before or shortly after a release of radioactive iodine and (iii) within a short period after an intake of radioactive iodine.

A-3. In the absence of national guidance, the generic criteria could be used as a basis for the development of criteria at the national level. In exceptional situations, the use of higher values for the generic criteria may be necessary, such as when no replacement food or water is available.
TABLE A–1. GENERIC CRITERIA FOR PROTECTIVE ACTIONS AND OTHER RESPONSE ACTIONS IN AN EMERGENCY TO REDUCE THE RISK OF STOCHASTIC EFFECTS

Generic criteria

Examples of protective actions and

other response actions

Projected dose that exceeds the following generic criteria : Take urgent protective actions and other response actions

H _thyroid

50 mSv in the first 7 days

Iodine thyroid blocking

E

100 mSv in the first 7 days

Sheltering; evacuation; decontamination;

restrictions on food, milk and drinking water;

contamination control; reassurance of the public

H _fetus

100 mSv in the first 7 days

Projected dose that exceeds the following generic criteria : Take early protective actions and other response actions

E

100 mSv in the first year

Temporary relocation; decontamination; restrictions on food, milk and drinking water; reassurance of the public

H _fetus

100 mSv for the full period of in utero development

Dose that has been received and that exceeds the following generic criteria : Take longer term medical actions to detect and to effectively treat radiation induced health effects

E

100 mSv in a month

Health screening based on equivalent doses to

specific radiosensitive organs (as a basis for medical follow-up); counselling

H _fetus

100 mSv for the full period of in utero development

Counselling to allow informed decisions to be made

in individual circumstances

7. Definitions
The definitions are available here as of page 381 or in the electronic IAEA Nuclear Safety and Security Glossary.
Table Of Contents
Table Of Contents
Table Of Contents 1. Introduction
1. Introduction #
TOC \z \h 1. Introduction PAGE # Background
Background #
Background PAGE # The system of protection and safety
The system of protection and safety #
The system of protection and safety PAGE # Types of exposure situation
Types of exposure situation #
Types of exposure situation PAGE # Dose constraints and reference levels
Dose constraints and reference levels #
Dose constraints and reference levels PAGE # Protection of the environment
Protection of the environment #
Protection of the environment PAGE # Interfaces between safety and security
Interfaces between safety and security #
Interfaces between safety and security PAGE # Objective
Objective #
Objective PAGE # Scope
Scope #
Scope PAGE # Structure
Structure #
Structure PAGE # 2. General Requirements for Protection and Safety
2. General Requirements for Protection and Safety #
2. General Requirements for Protection and Safety PAGE # Definitions
Definitions #
Definitions PAGE # Interpretation
Interpretation #
Interpretation PAGE # Resolution of Conflicts
Resolution of Conflicts #
Resolution of Conflicts PAGE # Entry into Force
Entry into Force #
Entry into Force PAGE # Application of the Principles of Radiation Protection
Application of the Principles of Radiation Protection #
Application of the Principles of Radiation Protection PAGE # Requirement 1: Application of the principles of radiation protection
Requirement 1: Application of the principles of radiation protection #
Requirement 1: Application of the principles of radiation protection PAGE # Responsibilities of the Government
Responsibilities of the Government #
Responsibilities of the Government PAGE # Requirement 2: Establishment of a legal and regulatory framework
Requirement 2: Establishment of a legal and regulatory framework #
Requirement 2: Establishment of a legal and regulatory framework PAGE # Responsibilities of the Regulatory Body
Responsibilities of the Regulatory Body #
Responsibilities of the Regulatory Body PAGE # Requirement 3: Responsibilities of the regulatory body
Requirement 3: Responsibilities of the regulatory body #
Requirement 3: Responsibilities of the regulatory body PAGE # Responsibilities for Protection and Safety
Responsibilities for Protection and Safety #
Responsibilities for Protection and Safety PAGE # Requirement 4: Responsibilities for Protection and Safety
Requirement 4: Responsibilities for Protection and Safety #
Requirement 4: Responsibilities for Protection and Safety PAGE # Management Requirements
Management Requirements #
Management Requirements PAGE # Requirement 5: Management for protection and safety
Requirement 5: Management for protection and safety #
Requirement 5: Management for protection and safety PAGE # Protection and safety elements of the management system
Protection and safety elements of the management system #
Protection and safety elements of the management system PAGE # Safety Culture
Safety Culture #
Safety Culture PAGE # Human factors
Human factors #
Human factors PAGE # 3. Planned Exposure Situations
3. Planned Exposure Situations #
3. Planned Exposure Situations PAGE # Scope
Scope #
Scope PAGE # Generic Requirements
Generic Requirements #
Generic Requirements PAGE # Requirement 6: Graded approach
Requirement 6: Graded approach #
Requirement 6: Graded approach PAGE # Requirement 7: Notification and authorization
Requirement 7: Notification and authorization #
Requirement 7: Notification and authorization PAGE # Requirement 8: Exemption and clearance
Requirement 8: Exemption and clearance #
Requirement 8: Exemption and clearance PAGE # Requirement 9: Responsibilities of registrants and licensees in planned exposure situations
Requirement 9: Responsibilities of registrants and licensees in planned exposure situations #
Requirement 9: Responsibilities of registrants and licensees in planned exposure situations PAGE # Requirement 10: Justification of practices
Requirement 10: Justification of practices #
Requirement 10: Justification of practices PAGE # Requirement 11: Optimization of protection and safety
Requirement 11: Optimization of protection and safety #
Requirement 11: Optimization of protection and safety PAGE # Requirement 12: Dose limits
Requirement 12: Dose limits #
Requirement 12: Dose limits PAGE # Requirement 13: Safety assessment
Requirement 13: Safety assessment #
Requirement 13: Safety assessment PAGE # Requirement 14: Monitoring for verification of compliance
Requirement 14: Monitoring for verification of compliance #
Requirement 14: Monitoring for verification of compliance PAGE # Requirement 15: Prevention and mitigation of accidents
Requirement 15: Prevention and mitigation of accidents #
Requirement 15: Prevention and mitigation of accidents PAGE # Requirement 16: Investigations and feedback of information on operating experience
Requirement 16: Investigations and feedback of information on operating experience #
Requirement 16: Investigations and feedback of information on operating experience
PAGE # Requirement 17: Radiation generators and radioactive sources
Requirement 17: Radiation generators and radioactive sources #
Requirement 17: Radiation generators and radioactive sources PAGE # Requirement 18: Human imaging using radiation for purposes other than medical diagnosis, medical treatment or biomedical research
Requirement 18: Human imaging using radiation for purposes other than medical diagnosis, medical treatment or biomedical research #
Requirement 18: Human imaging using radiation for purposes other than medical diagnosis, medical treatment or biomedical research PAGE # Occupational Exposures
Occupational Exposures #
Occupational Exposures PAGE # Scope
Scope #
Scope PAGE # Requirement 19: Responsibilities of the regulatory body specific to occupational exposure
Requirement 19: Responsibilities of the regulatory body specific to occupational exposure #
Requirement 19: Responsibilities of the regulatory body specific to occupational exposure PAGE # Requirement 20: Requirements for monitoring and recording of occupational exposures
Requirement 20: Requirements for monitoring and recording of occupational exposures #
Requirement 20: Requirements for monitoring and recording of occupational exposures PAGE # Requirement 21: Responsibilities of employers, registrants and licensees for the protection of workers
Requirement 21: Responsibilities of employers, registrants and licensees for the protection of workers #
Requirement 21: Responsibilities of employers, registrants and licensees for the protection of workers PAGE # Requirement 22: Compliance by workers
Requirement 22: Compliance by workers #
Requirement 22: Compliance by workers PAGE # Requirement 23: Cooperation between employers and registrants and licensees
Requirement 23: Cooperation between employers and registrants and licensees #
Requirement 23: Cooperation between employers and registrants and licensees
PAGE # Requirement 24: Arrangements under the radiation protection programme
Requirement 24: Arrangements under the radiation protection programme #
Requirement 24: Arrangements under the radiation protection programme
PAGE # Requirement 25: Assessment of occupational exposure and workers’ health surveillance
Requirement 25: Assessment of occupational exposure and workers’ health surveillance #
Requirement 25: Assessment of occupational exposure and workers’ health surveillance PAGE # Requirement 26: Information, instruction and training
Requirement 26: Information, instruction and training #
Requirement 26: Information, instruction and training PAGE # Requirement 27: Conditions of service
Requirement 27: Conditions of service #
Requirement 27: Conditions of service PAGE # Requirement 28: Special arrangements for protection and safety for female workers and for persons under 18 years of age undergoing training
Requirement 28: Special arrangements for protection and safety for female workers and for persons under 18 years of age undergoing training #
Requirement 28: Special arrangements for protection and safety for female workers and for persons under 18 years of age undergoing training PAGE # Public Exposures
Public Exposures #
Public Exposures PAGE # Scope
Scope #
Scope PAGE # Requirement 29: Responsibilities of the government and the regulatory body specific to public exposure
Requirement 29: Responsibilities of the government and the regulatory body specific to public exposure #
Requirement 29: Responsibilities of the government and the regulatory body specific to public exposure PAGE # Requirement 30: Responsibilities of relevant parties specific to public exposure
Requirement 30: Responsibilities of relevant parties specific to public exposure #
Requirement 30: Responsibilities of relevant parties specific to public exposure
PAGE # Requirement 31: Radioactive waste and discharges
Requirement 31: Radioactive waste and discharges #
Requirement 31: Radioactive waste and discharges PAGE # Requirement 32: Monitoring and reporting
Requirement 32: Monitoring and reporting #
Requirement 32: Monitoring and reporting PAGE # Requirement 33: Consumer products
Requirement 33: Consumer products #
Requirement 33: Consumer products PAGE # Medical Exposures
Medical Exposures #
Medical Exposures PAGE # Scope
Scope #
Scope PAGE # Requirement 34: Responsibilities of the government specific to medical exposure
Requirement 34: Responsibilities of the government specific to medical exposure #
Requirement 34: Responsibilities of the government specific to medical exposure
PAGE # Requirement 35: Responsibilities of the regulatory body specific to medical exposure
Requirement 35: Responsibilities of the regulatory body specific to medical exposure #
Requirement 35: Responsibilities of the regulatory body specific to medical exposure
PAGE # Requirement 36: Responsibilities of registrants and licensees specific to medical exposure
Requirement 36: Responsibilities of registrants and licensees specific to medical exposure #
Requirement 36: Responsibilities of registrants and licensees specific to medical exposure PAGE # Requirement 37: Justification of medical exposures
Requirement 37: Justification of medical exposures #
Requirement 37: Justification of medical exposures PAGE # Requirement 38: Optimization of protection and safety
Requirement 38: Optimization of protection and safety #
Requirement 38: Optimization of protection and safety PAGE # Requirement 39: Pregnant or breast-feeding female patients
Requirement 39: Pregnant or breast-feeding female patients #
Requirement 39: Pregnant or breast-feeding female patients PAGE # Requirement 40: Release of patients after radionuclide therapy
Requirement 40: Release of patients after radionuclide therapy #
Requirement 40: Release of patients after radionuclide therapy PAGE # Requirement 41: Unintended and accidental medical exposures
Requirement 41: Unintended and accidental medical exposures #
Requirement 41: Unintended and accidental medical exposures PAGE # Requirement 42: Reviews and records
Requirement 42: Reviews and records #
Requirement 42: Reviews and records PAGE # 4. Emergency Exposure Situations
4. Emergency Exposure Situations #
4. Emergency Exposure Situations PAGE # Scope
Scope #
Scope PAGE # Generic Requirements
Generic Requirements #
Generic Requirements PAGE # Requirement 43: Emergency management system
Requirement 43: Emergency management system #
Requirement 43: Emergency management system PAGE # Public Exposure
Public Exposure #
Public Exposure PAGE # Requirement 44: Preparedness and response for an emergency
Requirement 44: Preparedness and response for an emergency #
Requirement 44: Preparedness and response for an emergency PAGE # Exposure of Emergency Workers
Exposure of Emergency Workers #
Exposure of Emergency Workers PAGE # Requirement 45: Arrangements for controlling the exposure of emergency workers
Requirement 45: Arrangements for controlling the exposure of emergency workers #
Requirement 45: Arrangements for controlling the exposure of emergency workers
PAGE # Transition from an Emergency Situation to an Existing Exposure Situation
Transition from an Emergency Situation to an Existing Exposure Situation #
Transition from an Emergency Situation to an Existing Exposure Situation PAGE # Requirement 46: Arrangements for the transition from an emergency exposure situation to an existing exposure situation
Requirement 46: Arrangements for the transition from an emergency exposure situation to an existing exposure situation #
Requirement 46: Arrangements for the transition from an emergency exposure situation to an existing exposure situation PAGE # 5. Existing Exposure Situations
5. Existing Exposure Situations #
5. Existing Exposure Situations PAGE # Scope
Scope #
Scope PAGE # Generic Requirements
Generic Requirements #
Generic Requirements PAGE # Requirement 47: Responsibilities of the government specific to existing exposure situations
Requirement 47: Responsibilities of the government specific to existing exposure situations #
Requirement 47: Responsibilities of the government specific to existing exposure situations PAGE # Public Exposure
Public Exposure #
Public Exposure PAGE # Scope
Scope #
Scope PAGE # Requirement 48: Justification for protective actions and optimization of protection and safety
Requirement 48: Justification for protective actions and optimization of protection and safety #
Requirement 48: Justification for protective actions and optimization of protection and safety PAGE # Requirement 49: Responsibilities for remediation of areas with residual radioactive material
Requirement 49: Responsibilities for remediation of areas with residual radioactive material #
Requirement 49: Responsibilities for remediation of areas with residual radioactive material PAGE # Requirement 50: Public exposure due to radon indoors
Requirement 50: Public exposure due to radon indoors #
Requirement 50: Public exposure due to radon indoors PAGE # Requirement 51: Exposure due to radionuclides in commodities
Requirement 51: Exposure due to radionuclides in commodities #
Requirement 51: Exposure due to radionuclides in commodities PAGE # Occupational Exposure
Occupational Exposure #
Occupational Exposure PAGE # Scope
Scope #
Scope PAGE # Requirement 52: Exposure in workplaces
Requirement 52: Exposure in workplaces #
Requirement 52: Exposure in workplaces PAGE # Appendix I ‐ Schedule I : Exemption and Clearance
Appendix I ‐ Schedule I : Exemption and Clearance #
Appendix I ‐ Schedule I : Exemption and Clearance PAGE # Criteria for Exemption
Criteria for Exemption #
Criteria for Exemption PAGE # Criteria for Clearance
Criteria for Clearance #
Criteria for Clearance PAGE # Appendix II ‐ Schedule II: Categories for sealed sources used in common practices
Appendix II ‐ Schedule II: Categories for sealed sources used in common practices #
Appendix II ‐ Schedule II: Categories for sealed sources used in common practices PAGE # Appendix III ‐ Schedule III: Dose limits for planned exposure situations
Appendix III ‐ Schedule III: Dose limits for planned exposure situations #
Appendix III ‐ Schedule III: Dose limits for planned exposure situations PAGE # Occupational exposure
Occupational exposure #
Occupational exposure PAGE # Public exposure
Public exposure #
Public exposure PAGE # Verification of compliance with dose limits
Verification of compliance with dose limits #
Verification of compliance with dose limits PAGE # Appendix IV ‐ Schedule IV: Criteria for use in emergency preparedness and response
Appendix IV ‐ Schedule IV: Criteria for use in emergency preparedness and response #
Appendix IV ‐ Schedule IV: Criteria for use in emergency preparedness and response PAGE # TABLE IV.1. GENERIC CRITERIA FOR DOSES RECEIVED WITHIN A SHORT PERIOD OF TIME FOR WHICH PROTECTIVE ACTIONS AND OTHER RESPONSE ACTIONS ARE EXPECTED TO BE UNDERTAKEN UNDER ANY CIRCUMSTANCES TO AVOID OR TO MINIMIZE SEVERE DETERMINISTIC EFFECTS
TABLE IV.1. GENERIC CRITERIA FOR DOSES RECEIVED WITHIN A SHORT PERIOD OF TIME FOR WHICH PROTECTIVE ACTIONS AND OTHER RESPONSE ACTIONS ARE EXPECTED TO BE UNDERTAKEN UNDER ANY CIRCUMSTANCES TO AVOID OR TO MINIMIZE SEVERE DETERMINISTIC EFFECTS #
TABLE IV.1. GENERIC CRITERIA FOR DOSES RECEIVED WITHIN A SHORT PERIOD OF TIME FOR WHICH PROTECTIVE ACTIONS AND OTHER RESPONSE ACTIONS ARE EXPECTED TO BE UNDERTAKEN UNDER ANY CIRCUMSTANCES TO AVOID OR TO MINIMIZE SEVERE DETERMINISTIC EFFECTS PAGE # TABLE IV.2. GUIDANCE VALUES FOR RESTRICTING EXPOSURE OF EMERGENCY WORKERS
TABLE IV.2. GUIDANCE VALUES FOR RESTRICTING EXPOSURE OF EMERGENCY WORKERS #
TABLE IV.2. GUIDANCE VALUES FOR RESTRICTING EXPOSURE OF EMERGENCY WORKERS PAGE # References
References #
References PAGE # Annex I ‐ Generic criteria for protective actions and other response actions to reduce the risk of stochastic effects
Annex I ‐ Generic criteria for protective actions and other response actions to reduce the risk of stochastic effects #
Annex I ‐ Generic criteria for protective actions and other response actions to reduce the risk of stochastic effects PAGE # TABLE A–1. GENERIC CRITERIA FOR PROTECTIVE ACTIONS AND OTHER RESPONSE ACTIONS IN AN EMERGENCY TO REDUCE THE RISK OF STOCHASTIC EFFECTS
TABLE A–1. GENERIC CRITERIA FOR PROTECTIVE ACTIONS AND OTHER RESPONSE ACTIONS IN AN EMERGENCY TO REDUCE THE RISK OF STOCHASTIC EFFECTS #
TABLE A–1. GENERIC CRITERIA FOR PROTECTIVE ACTIONS AND OTHER RESPONSE ACTIONS IN AN EMERGENCY TO REDUCE THE RISK OF STOCHASTIC EFFECTS PAGE # 7. Definitions
7. Definitions #
7. Definitions PAGE #
1 ¹ FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANISATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, WORLD HEALTH ORGANIZATION, International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, IAEA Safety Series No. 115, IAEA, Vienna (1996).

2 ²The term ‘radiation’ in the context of these Standards means ionizing radiation.

3 ³Obligations expressed as ‘must’ statements in Section 1 are quoted from the Fundamental Safety Principles [1].

4 ⁴ FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANISATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, WORLD HEALTH ORGANIZATION, International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, IAEA Safety Series No. 115, IAEA, Vienna (1996).

5 ⁵The term ‘radiation risks’ is used in a general sense to refer to:

— Detrimental health effects of radiationexposure (including the likelihood of such effects occurring).

— Any other safety related risks (including those to the environment) that might arise as a direct consequence of:

Exposure to radiation;

The presence of radioactive material (including radioactive waste) or its release to the environment;

A loss of control over a nuclear reactor core, nuclear chain reaction, radioactive source or any other source of radiation.

6 ⁶The term ‘facilities and activities’ is a general term encompassing any human activity that may cause people to be exposed to radiation risks arising from naturally occurring or artificial sources. The term ‘facilities’ includes: nuclearfacilities; irradiation installations; some mining and raw material processingfacilities such as uranium mines; radioactive waste management facilities; and any other places where radioactive material is produced, processed, used, handled, stored or disposed of — or where radiation generators are installed — on such a scale that consideration of protection and safety is required. The term ‘activities’ includes: the production, use, import and export of radiation sources for industrial, research and medical purposes; the transport of radioactive material; the decommissioning of facilities; radioactive waste managementactivities such as the discharge of effluents; and some aspects of the remediation of sites affected by residues from past activities.

7 ⁷According to UNSCEAR [4], the worldwide average annual radiationdose from exposure due to naturally occurring radiation sources, including radon, is 2.4 mSv. In any large population, about 65% would be expected to have annual doses of between 1 and 3 mSv. About 25% of the population would be expected to have annual doses of less than 1 mSv, and about 10% would be expected to have annual doses greater than 3 mSv.

8 ⁸It is generally accepted, for example, that it is not feasible to control⁴⁰K in the body or cosmic radiation at the surface of the Earth.

9 ⁹‘Protection and safety is optimized’ means that optimization of protection and safety has been applied and the result of that process has been implemented.

10 ¹⁰States have different legal structures, and, therefore, the term ‘government’ as used in the IAEA safety standards is to be understood in a broad sense, and is accordingly interchangeable here with the term ‘State’.

11 ¹¹ Requirements on the governmental, legal and regulatory framework for safety of facilities and activities are established in Ref. [8].

12 ¹²‘Formal recognition’ means documented acknowledgement by the relevant authority that a person has the qualifications and expertise required for the responsibilities that he or she will bear in the conduct of the authorized activity.

13 ¹³Additional measures are taken for security in the transport of radioactive material. The IAEA issues guidance on security in the transport of radioactive material in the IAEA Nuclear Security Series of publications.

14 ¹⁴The regulatory body specifies which sources are to be included in the registers and inventories, with due consideration given to the associated risks.

15 ¹⁵Requirements on the management system for facilities and activities are established in Ref. [13].

16 ¹⁶For example, a sterilization gamma irradiation unit is a source for the practice of radiation preservation of food. An X ray unit may be a source for the practice of radiodiagnosis. A nuclear power plant is part of the practice of generating electricity by nuclear fission, and may be regarded as a single source (e.g. with respect to discharges) or as a collection of sources (e.g. for purposes of occupational radiation protection). A complex or multiple installation situated at one location or site may, as appropriate, be considered a single source for the purposes of application of these Standards.

17 ¹⁷A situation of exposure due to radionuclides of natural origin in food, feed, drinking water, agricultural fertilizer and soil amendments, construction materials and residual radioactive material in the environment is treated as an existing exposure situation regardless of the activity concentrations of the radionuclides concerned.

18 ¹⁸With regard to material being transported in accordance with the IAEA Transport Regulations [12], the requirements of these Standards for notification and authorization are fulfilled by means of compliance with the requirements of the IAEA Transport Regulations.

19 ¹⁹Typical practices that are suitable for registration are those for which: (i) safety can largely be ensured by the design of the facilities and equipment; (ii) the operating procedures are simple to follow; (iii) the training requirements for safety are minimal; and (iv) there is a history of few problems relating to safety in operations. Registration is best suited to those practices for which operations do not vary significantly.

20 ²⁰Such provision may involve several governmental authorities not necessarily having direct responsibility for protection and safety, such as ministries of health, justice, immigration and security.

21 ²¹This provision for the justification of any type of practice includes practices for which notification alone is sufficient.

22 ²²Particular requirements for the justification of medical exposure are specified in paras 3.155–3.161.

23 ²³This requirement is not intended to prohibit those practices that may involve the short term activation of commodities or products, for which there is no increase in radioactivity in the commodity or product as made available.

24 ²⁴Such purposes for performing human imaging using radiation include: assessment of fitness for employment (prior to employment or periodically during employment); assessment of physiological suitability for a career or a sport; assessment of athletes before a selection or transfer; determination of age for legal purposes; obtaining evidence for legal purposes; detection of drugs concealed within the body; immigration or emigration requirements; pre-insurance checks; and obtaining evidence for the purposes of a compensation claim.

25 ²⁵For occupational exposure, the relevant dose constraint is on individual doses to workers, established and used by registrants and licensees to set the range of options in optimizing protection and safety for the source. For public exposure, the relevant dose constraint is a source related value established or approved by the government or the regulatory body, with account taken of the doses from planned operations of all sources under control. The dose constraint for each particular source is intended, among other things, to ensure that the sum of doses from planned operations for all sources under control remains within the dose limit.

26 ²⁶ Requirements for the optimization of medical exposure are specified in paras 3.162–3.177.

27 ²⁷ Dose limits do not apply to medical exposures.

28 ²⁸ Requirements on safety assessment for facilities and activities are established in Ref. [14].

29 ²⁹A generic safety assessment is usually sufficient for types of source with a high degree of uniformity in design. A specific safety assessment is usually required in other cases; however, the specific safety assessment need not include those aspects covered by a generic safety assessment, if a generic safety assessment has been conducted for the type of source.

30 ³⁰For categories 1, 2 and 3 sealed sources as defined in Schedule II, the manufacturer may consider placement near the source, preferably on the shield or near the point of access to the source, of the supplementary symbol specified in Ref. [17]. The supplementary symbol is not placed on the external surfaces of transportpackages, freight containers or conveyances or on building access doors.

31 ³¹Such purposes for performing human imaging using radiation include: assessment of fitness for employment (prior to employment or periodically during employment); assessment of physiological suitability for a career or a sport; assessment of athletes before a selection or transfer; determination of age for legal purposes; obtaining evidence for legal purposes; detection of drugs concealed within the body; immigration or emigration requirements; pre-insurance checks; and obtaining evidence for the purposes of a compensation claim.

32 ³²The transport of radioactive material is regulated in accordance with the IAEA Transport Regulations [12].

33 ³³The distinction between types of worker in paras 3.100 and 3.101 for the purposes of monitoring has similarities to the distinction between category A and category B workers in European Union legislation [18].

34 ³⁴Records of occupational exposure are also referred to as ‘exposure records’ or ‘dose records’.

35 ³⁵ Notification of an employer of a suspected pregnancy or of breast-feeding cannot be made a requirement on a female worker in these Standards. However, it is necessary that all female workers understand the importance of making such notifications so that their working conditions may be modified accordingly.

36 ³⁶The term ‘providers of consumer products’ includes the designers, manufacturers, producers, constructors, installers, distributors, sellers, and importers and exporters of consumer products.

37 ³⁷ Dose contributions from possible future authorized practices have to be anticipated in an assessment made on the basis of realistic assumptions.

38 ³⁸ Requirements for the predisposal management of radioactive waste are established in Ref. [10] and requirements for the disposal of radioactive waste are established in Ref. [11].

39 ³⁹ Requirements on human imaging using radiation for purposes other than medical diagnosis, medical treatment or biomedical research (and, hence, not within the scope of medical exposure) are stated in paras 3.61–3.67.

40 ⁴⁰The selection of constraints for carers and comforters is a complex process in which a number of factors have to be taken into account, such as the age of the individual and for a woman the possibility of her being pregnant.

41 ⁴¹‘Specialized’ means specialized as acknowledged by the relevant professional body, health authority or appropriate organization.

42 ⁴²‘The appropriate area’ means, in the first instance, diagnostic radiology, image guided interventional procedures, or radiation therapy or nuclear medicine (diagnostic radiological procedures, therapeutic radiological procedures or both). The area of specialization is often likely to be narrower, however, in particular with regard to the radiological medical practitioner. Examples are dental, chiropractic or podiatric specialists in the case of diagnostic radiology, and cardiologists, urologists or neurologists in the case of image guided interventional procedures.

43 ⁴³The diagnostic or therapeutic benefit that medical exposures are expected to yield may not necessarily be to the person exposed. For patients, this is clearly the case, but for exposures in biomedical research the benefit is expected to be for biomedical sciences and for future health care. Similarly, the benefit for carers and comforters might be, for example, the successful performance of a diagnostic procedure on a child.

44 ⁴⁴The term ‘relatively high dose’ is intended to apply in a given context. Clearly, doses from therapeutic radiological procedures are included in ‘relatively high doses’, as are image guided interventional procedures. In medical imaging, ‘relatively high doses’ would include doses from exposures in computed tomography and in radiological procedures in nuclear medicine with higher doses.

45 ⁴⁵‘Independent verification’ ideally means verification by a different, independent medical physicist using different dosimetry equipment. However, other options, such as verification by a second medical physicist or verification using a second set of equipment, or even using a form of verification by postal thermoluminescence dosimetry, could be acceptable. In checking for compliance, the regulatory body needs to be aware of the limitations on local resources.

46 ⁴⁶‘Other means of communication’ include explicitly asking female patients whether they are or might be pregnant or whether they are breast-feeding.

47 ⁴⁷Table A–1 in the Annex (p. 380) provides a set of generic criteria for use in the protection strategy that are compatible with reference levels within a range of 20–100 mSv, and provides further details for specific actions in different time frames.

48 ⁴⁸The voluntary basis for actions to be taken by emergency workers is usually covered in emergency arrangements.

49 ⁴⁹In the case of exposure due to radon, the types of situation that are included in the scope of existing exposure situations will include exposure in workplaces for which the exposure due to radon is not required by or directly related to the work and for which annual average activity concentrations due to ²²²Rn might be expected not to exceed the reference level established in accordance with para. 5.27.

50 ⁵⁰Such actions include remedial actions such as the removal or reduction of the source giving rise to the exposure, as well as other longer term protective actions such as restriction of the use of construction materials, restriction of the consumption of foodstuffs and restriction of land use or of access to land or buildings.

51 ⁵¹In existing exposure situations that do not fall under the jurisdiction of the regulatory body, another relevant authority such as a health authority may have authority for implementing measures for protection and safety

52 ⁵²The implementation of remedial actions (remediation) does not imply the elimination of all radioactivity or all traces of radioactive substances. The optimization process may lead to extensive remediation but not necessarily to the restoration of previous conditions.

53 ⁵³Buildings with high occupancy factors for members of the public include kindergartens, schools and hospitals.

54 ⁵⁴Guidance on the preparation of an action plan for radon is provided in Ref. [6], for example.

55 ⁵⁵On the assumption of an equilibrium factor for ²²²Rn of 0.4 and an annual occupancy of 7000 h, the value of activity concentration due to ²²²Rn of 300 Bq/m³ corresponds to an annual effective dose of the order of 10 mSv.

56 ⁵⁶Examples of giving priority to reducing activity concentrations of ²²²Rn in those situations for which such action is likely to be most effective include (i) specifying the levels of activity concentrations of ²²²Rn in dwellings and other buildings with high occupancy factors at which protection can be considered optimized; (ii) identifying radon prone areas; (iii) identifying characteristics of buildings that are likely to give rise to elevated activity concentrations of ²²²Rn; and (iv) identifying and requiring preventive measures for radon in future buildings that can be introduced at relatively low cost.

57 ⁵⁷On the assumption of an equilibrium factor for ²²²Rn of 0.4 and an annual occupancy of 2000 h, the value of activity concentration due to 222Rn of 1000 Bq/m³ corresponds to an annual effective dose of the order of 10 mSv.

58 ⁵⁸The exemption values (activity concentrations) presented in Table I.1 have been calculated on the basis of scenarios involving a moderate amount of material: “The calculated values apply to practices involving small scale usage of activity where the quantities involved are at the most of the order of a tonne” (see Ref. [25]). The regulatory body will need to establish the amounts for which the concentration values in Table I.1 may be applied, bearing in mind that for many radionuclides, in particular those for which there is no corresponding value given in Table I.2 (p. 124), a restriction on the amount is not meaningful.

59 ⁵⁹The exemption levels set out in Table I.1 (p. 111) and the exemption and clearance levels set out in Table I.2 are subject to the following considerations: (a) they were derived using a conservative model based on (i) the criteria of paras I.2 and I.11, respectively, and a series of limiting (bounding) scenarios for use and disposal (see Refs [25, 26] in the case of Table I.1 and Ref. [27] in the case of Table I.2); (b) if there is more than one radionuclide, the derived exemption level or derived clearance level for the mixture is determined as specified in paras I.7 and I.14.

60 ⁶⁰Material containing radionuclides of natural origin at an activity concentration of less than 1 Bq/g for any radionuclide in the uranium decay chain or the thorium decay chain and of less than 10 Bq/g for ⁴⁰K is not subject to the requirements in Section 3 for planned exposure situations (para. 3.4(a)); hence, the concept of exemption from the requirements of these Standards does not apply for such material.

61 ⁶¹For the purposes of material in transport, ‘exemption’ means exemption from the requirements of the IAEA Transport Regulations [12].

62 ⁶²The exemption levels set out in Table I.1 (p. 111) and the exemption and clearance levels set out in Table I.2 are subject to the following considerations: (a) they were derived using a conservative model based on (i) the criteria of paras I.2 and I.11, respectively, and a series of limiting (bounding) scenarios for use and disposal (see Refs [25, 26] in the case of Table I.1 and Ref. [27] in the case of Table I.2); (b) if there is more than one radionuclide, the derived exemption level or derived clearance level for the mixture is determined as specified in paras I.7 and I.14.

63 ⁶³These values of activity concentration may also be applied for the clearance of materials arising from practices subject to the clearance criteria given in para. I.11, pending establishment of radionuclide specific values for the radionuclides of natural origin given in Table I.3.

64 ⁶⁴ Regulatory control of construction materials incorporating radionuclides is addressed in Section 5 as an existing exposure situation.

65 ⁶⁵For example, specific clearance levels may be developed for metals, for rubble from buildings and waste for disposal in landfill sites.

66 ⁶⁶The start of the averaging period shall be coincident with the first day of the relevant annual period after the date of entry into force of these Standards, with no retrospective averaging.

67 ⁶⁷The equivalent doselimits for the skin apply to the average dose over 1 cm2 of the most highly irradiated area of the skin. The dose to the skin also contributes to the effective dose, this contribution being the average dose to the entire skin multiplied by the tissue weighting factor for the skin.

68 ⁶⁸For example, in authorized, justified and planned operational conditions that lead to transitory increases in exposures.

69 ⁶⁹ Hp(10) is the personal dose equivalentHp(d) where d = 10 mm.

Definition

That which is established or required by the Fundamental Safety Principles (IAEA Safety Fundamentals) [EUROPEAN ATOMIC ENERGY COMMUNITY, INTERNATIONAL ATOMIC ENERGY AGENCY, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL LABOUR ORGANIZATION, INTERNATIONAL MARITIME ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, IAEA, Vienna (2006).] or IAEA Safety Requirements publications or by (national or international) laws or regulations.

Scope notes

Caution: In IAEA publications, requirement (and ‘required’ and other words deriving from the verb ‘to require’) should be used in this sense only. Care should be taken to avoid confusion: the use of ‘requirement’ in the more general sense of something that is necessary should be avoided.

Requirements, including numbered ‘overarching’ requirements, are expressed as ‘shall’ statements. Reported (quoted) requirements, e.g. in a Safety Guide, are reported using a formulation such as ‘it is required to…’.

Definition

Standards issued pursuant to Article III(A)(6)⁸ of the Statute of the IAEA [Statute of the International Atomic Energy Agency, IAEA, Vienna (1990).].

⁸ “[The Agency is authorized…] To establish or adopt, in consultation and, where appropriate, in collaboration with the competent organs of the United Nations and with the specialized agencies concerned, standards of safety for protection of health and minimization of danger to life and property (including such standards for labour conditions)…”

Scope notes

a. Requirements, regulations, standards, rules, codes of practice or recommendations established to protect people and the environment against ionizing radiation and to minimize danger to life and property.

b. Safety standards issued since 1997 in the IAEA Safety Standards Series are designated as Safety Fundamentals, Safety Requirements or Safety Guides.

c. Some safety standards issued prior to 1997 in the (defunct) Safety Series were designated Safety Standards, Codes, Regulations or Rules.

d. Furthermore, some publications issued in the (defunct) Safety Series were not safety standards, notably those designated Safety Practices or Procedures and Data.

e. Other IAEA publications, such as Safety Reports and TECDOCs (most of which are issued pursuant to Article VIII of the Statute), are not safety standards.

Definition

Caution: When used in IAEA publications, the term radiation usually refers to ionizing radiation only. The IAEA has no statutory responsibilities in relation to non-ionizing radiation.

Scope notes

Ionizing radiation can be divided into low linear energy transfer radiation and high linear energy transfer radiation (as a guide to its relative biological effectiveness), or into strongly penetrating radiation and weakly penetrating radiation (as an indication of its ability to penetrate shielding or the human body).

Definition

The protection of people against exposure to ionizing radiation or exposure due to radioactive material and the safety of sources, including the means for achieving this, and the means for preventing accidents and for mitigating the consequences of accidents if they do occur.

Scope notes

a. Safety is primarily concerned with maintaining control over sources, whereas (radiation) protection is primarily concerned with controlling exposure to radiation and its effects.

b. Clearly the two are closely connected: radiation protection (or radiological protection) is very much simpler if the source in question is under control, so safety necessarily contributes towards protection.

c. Sources come in many different types, and hence safety may be termed the safety of nuclear installations, radiation safety, the safety of radioactive waste management or safety in the transport of radioactive material, but protection (in this sense) is primarily concerned with protecting people against exposure, whatever the source, and so is always radiation protection.

d. For the purposes of the IAEA safety standards, protection and safety includes the protection of people against ionizing radiation and safety; it does not include non-radiation-related aspects of safety.

e. Protection and safety is concerned with both radiation risks under normal circumstances and radiation risks as a consequence of incidents, as well as with other possible direct consequences of a loss of control over a nuclear reactor core, nuclear chain reaction, radioactive source or any other source of radiation.

f. Safety measures include actions to prevent incidents and arrangements put in place to mitigate their consequences if they were to occur.

Definition

The protection of people from harmful effects of exposure to ionizing radiation, and the means for achieving this.

Scope notes

a. The International Commission on Radiological Protection and others use the term radiological protection, which is synonymous.

b. The accepted understanding of the term radiation protection is restricted to protection of people. Suggestions to extend the definition to include the protection of non-human species or the protection of the environment are controversial.

Definition

For the purposes of radiation protection, radiation capable of producing ion pairs in biological material(s).

Definition

The achievement of proper operating conditions, prevention of accidents and mitigation of accident consequences, resulting in protection of workers, the public and the environment from undue radiation risks.

Scope notes

a. Often abbreviated to safety in IAEA publications on nuclear safety. Safety means nuclear safety unless otherwise stated, in particular when other types of safety (e.g. fire safety, conventional industrial safety) are also being discussed. See protection and safety for a discussion of the relationship between nuclear safety and radiation protection.

b. There is not an exact distinction between the general terms safety and security. In general, security is concerned with intentional actions by people that could cause or threaten harm to other people; safety is concerned with the broader issue of harmful consequences to people (and to the environment) arising from exposure to radiation, whatever the cause.

c. The interaction between arrangements for security and arrangements for safety depends on the context. Areas in which arrangements for safety and arrangements for security interact include, for example: the regulatory infrastructure; engineering provisions in the design and construction of nuclear installations and other facilities; controls on access to nuclear installations and other facilities; the categorization of radioactive sources; source design; the security of the management of radioactive sources and radioactive material; the recovery of sources that are not under regulatory control; emergency response plans; and radioactive waste management.

d. See protection and safety for a discussion of the relationship between nuclear safety and radiation protection.

Definition

Any substance, whether processed, semi-processed or raw, that is intended for human consumption.

Scope notes

This includes foodstuffs and drink (other than fresh water), chewing gum and substances used in the preparation or processing of food; it does not include cosmetics, tobacco or drugs. Consumption in this context refers to ingestion.

Definition

The phenomenon whereby atoms undergo spontaneous random disintegration, usually accompanied by the emission of radiation.

Scope notes

Caution: In IAEA publications, radioactivity should be used only to refer to the phenomenon.

Caution: To refer to the physical quantity or to an amount of a radioactive substance, use activity.

Definition

A naturally occurring source of radiation, such as the sun and stars (sources of cosmic radiation) and rocks and soil (terrestrial sources of radiation), or any other material whose radioactivity is for all intents and purposes due only to radionuclides of natural origin, such as products or residues from the processing of minerals; but excluding radioactive material for use in a nuclear installation and radioactive waste generated in a nuclear installation.

Scope notes

Examples of natural sources include naturally occurring radioactive material (NORM) associated with the processing of raw materials (e.g. feedstocks, intermediate products, final products, co-products, waste).

Definition

The conditions under which people, animals and plants live or develop and which sustain all life and development; especially such conditions as affected by human activities.

Scope notes

See also protection of the environment

Definition

1. Material designated in national law or by a regulatory body as being subject to regulatory control because of its radioactivity.

Scope notes

a. Some publications in the Nuclear Security Series extend the definition, for the avoidance of doubt, to indicate that “In the absence of such a designation by a State, any material for which protection is required by the current version of the International Basic Safety Standards” [Objective and Essential Elements of a State’s Nuclear Security Regime, IAEA Nuclear Security Series No. 20, IAEA, Vienna (2013)].

b. Caution: This is the ‘regulatory’ meaning of radioactive (2), and should not be confused with the ‘scientific’ meaning of radioactive (1): ‘exhibiting radioactivity; emitting or relating to the emission of ionizing radiation or particles’.

c. Caution: The ‘scientific’ meaning of radioactive (1) — as in radioactive substance — refers only to the presence of radioactivity, and gives no indication of the magnitude of the hazard involved.

d. Caution: The term radioactive substance is also used to indicate that the ‘scientific’ meaning of radioactive (see radioactive (1)) is intended, rather than the ‘regulatory’ meaning of radioactive (see radioactive (2)) suggested by the term radioactive material.

e. Caution: However, in some States the term radioactive substance is used for the ‘regulatory’ purpose. It is therefore essential that any such distinctions in meaning are clarified.

f.Caution: In some Nuclear Security Series publications (e.g. Refs [Nuclear Security Recommendations on Physical Protection of Nuclear Material and Nuclear Facilities, INFCIRC/225/Revision 5, IAEA Nuclear Security Series No. 13, IAEA, Vienna (2011), Nuclear Security Recommendations on Radioactive Material and Associated Facilities, IAEA Nuclear Security Series No. 14, IAEA, Vienna (2011)]) it is stated or implied that radioactive substance is synonymous with radioactive material, in order to confirm consistency with the 2005 CPPNM Amendment [Amendment to the Convention on the Physical Protection of Nuclear Material, INFCIRC/274/Rev. 1/Mod. 1 (Corrected), IAEA, Vienna (2021).]. In contexts related to the CPPNM Amendment, the terms are synonymous, but in general they may have different meanings.

g. In regulatory terminology in some States, radioactive material ceases to be radioactive material when it becomes radioactive waste; the term radioactive substance is used to cover both, that is radioactive substance includes radioactive material and radioactive waste.

h. Caution:Radioactive material should be used in the singular unless reference is expressly being made to the presence of various types of radioactive material.

Definition

Strictly: relating to a nucleus; relating to or using energy released in nuclear fission or fusion. (adjective)

Scope notes

a. Caution: The adjective ‘nuclear’ is used in many phrases to modify a noun that it cannot logically modify. It must be borne in mind that the meaning of such phrases may be unclear (as opposed to nuclear).

b. Caution: The phrases may therefore need to be explained, and their usage may be open to misunderstanding, misrepresentation or mistranslation.

c. Caution: Such phrases include: nuclear accident; nuclear community; nuclear emergency; nuclear facility; nuclear fuel; nuclearincident; nuclear installation; nuclear material; nuclear medicine; (a) nuclear power; nuclear safety; and nuclear security.

Definition

Detrimental health effects of exposure to radiation (including the likelihood of such effects occurring), and any other safety related risks (including those to the environment) that might arise as a direct consequence of:
- (a) Exposure to radiation;
- (b) The presence of radioactive material (including radioactive waste) or its release to the environment;
- (c) A loss of control over a nuclear reactor core, nuclear chain reaction, radioactive source or any other source of radiation. (From [EUROPEAN ATOMIC ENERGY COMMUNITY, INTERNATIONAL ATOMIC ENERGY AGENCY, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL LABOUR ORGANIZATION, INTERNATIONAL MARITIME ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, IAEA, Vienna (2006).].)

Scope notes

For the purposes of the IAEA safety standards, it is assumed that there is no threshold level of radiation dose below which there are no associated radiation risks.

Safety Requirements and Safety Guides specify the radiation exposures and other radiation risks to which they refer.

Definition

1. The state or condition of being subject to irradiation.

Scope notes

Caution: Exposure should not be used as a synonym for dose. Dose is a measure of the effects of exposure.

Exposure to ionizing radiation can be broadly divided into categories of exposure (see categories of exposure) according to the status of the individual(s) exposed; into exposure situations according to the circumstances of the exposure; and according to the source of the exposure.

Definition

A radiation induced health effect for which generally a threshold level of dose exists above which the severity of the effect is greater for a higher dose.

Scope notes

a. The level of the threshold dose is characteristic of the particular health effect but may also depend, to a limited extent, on the exposed individual.

b. Examples of deterministic effects include erythema, damage to the haemopoietic system and acute radiation syndrome (radiation sickness).

c. Deterministic effects are also referred to as (harmful) tissue reactions.

d. The term non-stochastic effect is used in some older publications, but is now superseded.

e. Contrasting term: stochastic effect.

Definition

1. A measure of the energy deposited by radiation in a target.

Scope notes

For definitions of the most important such measures, see dose quantities and dose concepts.

Definition

A radiation induced health effect that occurs in a descendant of the exposed person.

Scope notes

a. The less precise term genetic effect is also used, but hereditary effect is preferred.

b. Hereditary effects are usually stochastic effects.

c. Contrasting term: somatic effect.

Definition

A radiation induced health effect, the probability of occurrence of which is greater for a higher radiationdose and the severity of which (if it occurs) is independent of dose.

Scope notes

Contrasting term: deterministic effect.

Stochastic effects may be somatic effects or hereditary effects and generally occur without a threshold level of dose. Examples include solid cancers and leukaemia.

Definition

The lifetime risk or radiation detriment assumed to result from exposure to unit equivalent dose or effective dose.

Definition

3. The probability of a specified health effect occurring in a person or group as a result of exposure to radiation.

Scope notes

a. The health effect(s) in question must be stated — for example, risk of fatal cancer, risk of serious

b. Commonly expressed as the product of the probability that exposure will occur and the probability that the exposure, assuming that it occurs, will cause the specified health effect.

c. The latter probability is sometimes termed the conditional risk.

Definition

The SI unit of equivalent dose and effective dose, equal to 1 J/kg.

Definition

This term encompasses several sub-terms such as deterministic effect, stochastic effect, somatic effect, hereditary effect, late effect

Definition

The process by means of which systems and components of facilities and activities, having been constructed, are made operational and verified to be in accordance with the design and to have met the required performance criteria.

Scope notes

Commissioning may include both non-nuclear and/or non-radioactive and nuclear and/or radioactive testing.

The terms siting, design, construction, commissioning, operation and decommissioning are normally used to delineate the six major stages of the lifetime of an authorized facility and of the associated licensing process. In the special case of disposal facilities for radioactive waste, decommissioning is replaced in this sequence by closure.

Definition

These include: nuclear facilities; irradiation installations; some mining and raw material processing facilities such as uranium mines; radioactive waste management facilities; and any other places where radioactive material is produced, processed, used, handled, stored or disposed of — or where radiation generators are installed — on such a scale that consideration of protection and safety is required.

Scope notes

‘Facilities’ includes:
(a) Nuclear power plants;
(b) Other reactors (such as research reactors and critical assemblies);
(c) Enrichment facilities and nuclear fuel fabrication facilities;
(d) Conversion facilities used to generate uranium hexafluoride (UF₆);
(e) Storage facilities and reprocessing plants for irradiated fuel;
(f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of;
(g) Any other places where radioactive materials are produced, processed, used, handled or stored;
(h) Irradiation installations for medical, industrial, research and other purposes, and any places where radiation generators are installed;
(i)Facilities where the mining and processing of radioactive ores (such as ores of uranium and thorium) are carried out

Definition

2. These include: the production, use, import and export of radiation sources for industrial, research and medical purposes; the transport of radioactive material; the decommissioning of facilities; radioactive waste management activities such as the discharge of effluents; and some aspects of the remediation of sites affected by residues from past activities.

Scope notes

The intention is to include any human activity that introduces additional sources of radiation or additional exposure pathways, or that modifies the network of exposure pathways from existing sources, so as to increase the exposure or the likelihood of exposure of people or the number of people exposed.

‘Activities’ includes:
(a) The production, use, import and export of radiation sources for medical, industrial, research and other purposes;
(b) The transport of radioactive material;
(c) The decommissioning of facilities and the closure of repositories for radioactive waste;
(d) The close-out of facilities where the mining and processing of radioactive ores was carried out;
(e) Activities for radioactive waste management such as the discharge of effluents;
(f) The remediation of sites affected by residues from past activities

Definition

1. For legal and regulatory purposes, waste that contains, or is contaminated with, radionuclides at activity concentrations greater than clearance levels as established by the regulatory body.

Scope notes

a. In effect, radioactive material in gaseous, liquid or solid form for which no further use is foreseen.

b. Caution: It should be recognized that this definition is purely for regulatory purposes, and that material with activity concentrations equal to or less than clearance levels is radioactive from a physical viewpoint, although the associated radiological hazards are considered negligible. See radioactive, radioactive material, radioactive substance.

c. Waste should be used in the singular unless reference is expressly being made to the presence of various types of waste.

Definition

The action or process of setting free or being set free, or of allowing or being allowed to move or flow freely.

Scope notes

Caution: Release is used in both a physical ‘scientific’ sense (see discharge (1)) and a ‘regulatory’ sense (see clearance), as well as in the usual sense of, for example, a release of energy.

Definition

1. A source containing radioactive material that is used as a source of radiation.

Definition

1. Anything that may cause radiation exposure — such as by emitting ionizing radiation or by releasing radioactive substances or radioactive material — and can be treated as a single entity for purposes of protection and safety.

Scope notes

b. A complex or multiple installation situated at one location or site may, as appropriate, be considered a single source for the purposes of application of safety standards.

a. For example, materials emitting radon are sources in the environment; a sterilization gamma irradiation unit is a source for the practice of irradiation preservation of food and sterilization of other products; an X ray unit may be a source for the practice of radiodiagnosis; a nuclear power plant is part of the practice of generating electricity by nuclear fission, and may be regarded as a source (e.g. with respect to discharges to the environment) or as a collection of sources (e.g. for purposes of occupational radiation protection purposes).

<h2>Definition</h2>1. A multiattribute quantity expressing hazard, danger or chance of harmful or injurious consequences associated with exposures or potential exposures. It relates to quantities such as the probability that specific deleterious consequences may arise and the magnitude and character of such consequences.<h2>Scope notes</h2><ul><li>In mathematical terms, this can be expressed generally as a set of triplets, <img src="/PoolParty/OpenConfigPathResourceProvider/frontendroot?fileName=custom/iaea-safety-glossary/images/docimg/formula-risk.jpg" style= "vertical-align: middle" style= "vertical-align: middle" alt="formula" height="30">, where Sis an identification or description of a scenario i, pis the probability of that scenario and Xis a measure of the consequence of the scenario. The concept of risk is sometimes also considered to include uncertainty in the probabilities pof the scenarios.</li></ul>

Definition

Any organization, corporation, partnership, firm, association, trust, estate, public or private institution, group, political or administrative entity, or other persons designated in accordance with national legislation who or which has responsibility and authority for any action having implications for protection and safety.

Scope notes

Supersedes the term [legal person], which is contrasted in legal texts with ‘natural person’, meaning an individual.

Definition

A general term encompassing nuclear facilities, uses of all sources of ionizing radiation, all radioactive waste management activities, transport of radioactive material and other practices or circumstances in which people may be subject to exposure to radiation from naturally occurring or artificial sources.

Scope notes

a. The term facilities and activities is intended to provide an alternative to the terminology of sources and practices (or interventions) to refer to general categories of situations.

b. For example, a practice may involve many different facilities and/or activities, whereas the general definition (1) of source is too broad in some cases: a facility or activity might constitute a source, or might involve the use of many sources, depending upon the interpretation used.

c. The term facilities and activities is very general, and includes those for which little or no regulatory control may be necessary or achievable: the more specific terms authorized facility and authorized activity should be used to distinguish those facilities and activities for which any form of authorization has been given.

d. In the Fundamental Safety Principles (IAEA Safety Fundamentals), the term ‘facilities and activities — existing and new — utilized for peaceful purposes’ is abbreviated for convenience to facilities and activities as a general term encompassing any human activity that may cause people to be exposed to radiation risks arising from naturally occurring or artificial sources (see EUROPEAN ATOMIC ENERGY COMMUNITY, INTERNATIONAL ATOMIC ENERGY AGENCY, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL LABOUR ORGANIZATION, INTERNATIONAL MARITIME ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, IAEA, Vienna (2006), para. 1.9).

f. Facilities and activities are listed as follows in [INTERNATIONAL ATOMIC ENERGY AGENCY, Safety Assessment for Facilities and Activities, IAEA Safety Standards Series No. GSR Part 4 (Rev. 1), IAEA, Vienna (2015)]:
‘Facilities’ includes:
(a) Nuclear power plants;
(b) Other reactors (such as research reactors and critical assemblies);
(c) Enrichment facilities and nuclear fuel fabrication facilities;
(d) Conversion facilities used to generate uranium hexafluoride (UF₆);
(e) Storage facilities and reprocessing plants for irradiated fuel;
(f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of;
(g) Any other places where radioactive materials are produced, processed, used, handled or stored;
(h) Irradiation installations for medical, industrial, research and other purposes, and any places where radiation generators are installed;
(i)Facilities where the mining and processing of radioactive ores (such as ores of uranium and thorium) are carried out
‘Activities’ includes:
(a) The production, use, import and export of radiation sources for medical, industrial, research and other purposes;
(b) The transport of radioactive material;
(c) The decommissioning of facilities and the closure of repositories for radioactive waste;
(d) The close-out of facilities where the mining and processing of radioactive ores was carried out;
(e) Activities for radioactive waste management such as the discharge of effluents;
(f) The remediation of sites affected by residues from past activities

e. For safeguards purposes, see the definition of facility in the Safeguards Glossary [IAEA Safeguards Glossary (2022 Edition), IAEA, Vienna].

Definition

1. An authority or a system of authorities designated by the government of a State as having legal authority for conducting the regulatory process, including issuing authorizations, and thereby regulating the nuclear, radiation, radioactive waste and transportsafety.

Scope notes

a. The regulatory body is generally a national entity, established and empowered by law, whose organization, management, functions, processes, responsibilities and competences are subject to the requirements of IAEA safety standards.

b. The national competent authority for the regulation of radioactive materialtransport (see INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018)) is included in this description, as is the regulatory body for protection and safety.

c. Caution: Supersedes the term regulatory authority, which should not be used.

Definition

1. The process of determining for a planned exposure situation whether a practice is, overall, beneficial; that is, whether the expected benefits to individuals and to society from introducing or continuing the practice outweigh the harm (including radiation detriment) resulting from the practice.

Definition

2. The management of the radiation dose to the patient commensurate with the medical purpose.

Scope notes

a. For medical exposures of patients.

b. ‘Optimization of protection and safety has been implemented’ means that optimization of protection and safety has been applied and the results of that process have been implemented.

c. Caution: This is not the same as optimization of the process or practice concerned. An explicit term such as optimization of protection and safety should be used.

d. Caution: The acronym ALARA should not be used to mean optimization of protection and safety.

Definition

1. Any unintended event, including operating errors, equipment failures and other mishaps, the consequences or potential consequences of which are not negligible from the point of view of protection and safety.

Scope notes

Caution: In the 2008 INES Manual (INTERNATIONAL ATOMIC ENERGY AGENCY, INES: The International Nuclear and Radiological Event Scale User’s Manual, 2008 Edition, IAEA, Vienna (2013)), there was a fundamental mismatch between the terminology used in safety standards and the designations used in INES. In short, events that would be considered accidents according to the safety standards definition may be accidents or incidents (i.e. not accidents) in INES terminology. This was not a serious day to day problem because the two areas are quite separate and have quite different purposes. However, it was a potential cause of confusion in communication with the news media and the public.

Definition

The capability to take actions that will effectively mitigate the consequences of an emergency for human life, health, property and the environment.

Definition

Any unintended event, including operating errors, equipment failures, initiating events, accident precursors, near misses or other mishaps, or unauthorized act, malicious or non-malicious, the consequences or potential consequences of which are not negligible from the point of view of protection and safety.

Scope notes

b. Caution: The word incident is sometimes used, in INES 2008 Manual [INTERNATIONAL ATOMIC ENERGY AGENCY, INES: The International Nuclear and Radiological Event Scale User’s Manual, 2008 Edition, IAEA, Vienna (2013).], to describe events that are, in effect, minor accidents, i.e. that are distinguished from accidents only in terms of being less severe.

c. Caution: This is a distinction with little basis in general usage, in which an incident can be minor or major, just as an accident can; however, unlike an accident, an incident can be caused intentionally.

d. The definition of incident given was derived on the basis of the entries for accident and event and the explanation of the term incident given in SF-1 [EUROPEAN ATOMIC ENERGY COMMUNITY, INTERNATIONAL ATOMIC ENERGY AGENCY, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL LABOUR ORGANIZATION, INTERNATIONAL MARITIME ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, IAEA, Vienna (2006).].

a. See also event and International Nuclear and Radiological Event Scale.

Definition

1. An action for the purposes of avoiding or reducing doses that might otherwise be received in an emergency exposure situation or an existing exposure situation.

Scope notes

This is related to radiation protection (see protection (1), and protection and safety).

Definition

2. The process of determining for an emergency exposure situation or an existing exposure situation whether a proposed protective action or remedial action is likely, overall, to be beneficial; that is, whether the expected benefits to individuals and to society (including the reduction in radiation detriment) from introducing or continuing the protective action or remedial action outweigh the cost of such action and any harm or damage caused by the action.

Definition

The value of the effective dose or the equivalent dose to individuals in planned exposure situations that is not to be exceeded.

Definition

This term encompasses several sub-terms, such as direct cause, latent weakness, observed cause and root cause

Definition

2. Radioactive material used as a source of radiation.

Scope notes

Such as those sources used for medical applications or in industrial instruments. These are, of course, sources as defined in (1), but this usage in (2) is less general.

Definition

A structure or an installation that houses a particle accelerator, X ray apparatus or large radioactive source and that can produce high radiation fields.

Scope notes

Irradiation installations include installations for external beam radiation therapy, installations for sterilization or preservation of commercial products and some installations for industrial radiography.

Definition

1. Facility specifically designed to handle, treat, condition, temporarily store or permanently dispose of radioactive waste.

<h2>Definition</h2>1. All administrative and operational activities involved in the handling, pretreatment, treatment, conditioning, transport, storage and disposal of radioactive waste <img src="https://vocabulary.iaea.org/https://nucleus.iaea.org/sites/nss-oui/Figures/i_8960bfd7-fd63-4f8f-a6b1-ee89e5ede97b.JPG" style="width: 480px;">

Definition

Any person or organization to whom a registrant or licensee assigns duties, totally or partially, in relation to the design, manufacture, production or construction of a source.

Scope notes

An importer of a source is considered a supplier of the source.

The term supplier (of a source) includes designers, manufacturers, producers, constructors, assemblers, installers, distributors, sellers, importers or exporters of a source.

Definition

A device capable of generating ionizing radiation, such as X rays, neutrons, electrons or other charged particles, that may be used for scientific, industrial or medical purposes.

Definition

Exposure incurred by patients for the purposes of their own medical or dental diagnosis (diagnostic exposure) or medical treatment (therapeutic exposure); by carers and comforters; and by volunteers subject to exposure as part of a programme of biomedical research.

Scope notes

See patient.

Definition

An individual who is a recipient of services of health professionals and/or their agents that are directed at (a) promotion of health; (b) prevention of illness and injury; (c) monitoring of health; (d) maintaining health; and (e) medical treatment of diseases, disorders and injuries in order to achieve a cure or, failing that, optimum comfort and function. Some asymptomatic individuals are included.

Scope notes

For the purpose of the requirements on medical exposure in the IAEA safety standards, the term ‘patient’ refers only to those individuals undergoing radiological procedures.

Definition

An individual who has been formally recognized through appropriate national procedures to practise a profession related to health (e.g. medicine, dentistry, chiropractic, podiatry, nursing, medical physics, medical radiation technology, radiopharmacy, occupational health).

Scope notes

Used to distinguish from a referring medical practitioner or a radiological medical practitioner, who satisfy additional criteria.

Definition

A health professional with specialist education and training in the medical uses of radiation, who is competent to perform independently or to oversee radiological procedures in a given specialty.

Scope notes

Competence of persons is normally assessed by the State by having a formal mechanism for registration, accreditation or certification of radiological medical practitioners in the given specialty (e.g. radiology, radiation therapy, nuclear medicine, dentistry, cardiology).

States that have yet to develop such a mechanism need to assess the education, training and competence of any individual proposed by the licensee to act as a radiological medical practitioner and to decide, on the basis of either international standards or standards of a State where such a system exists, whether such an individual could undertake the functions of a radiological medical practitioner, within the required specialty.

Definition

2. Any material containing radionuclides where both the activity concentration and the total activity in the consignment exceed the values specified in [paras 402-407 of the Transport Regulations]. (See INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018).)

Scope notes

Caution: This usage is specific to the Transport Regulations, and should otherwise be avoided.

Definition

The granting by a regulatory body or other governmental body of written permission for a person or organization (the operator) to conduct specified activities.

Scope notes

a. Authorization could include, for example, licensing (issuing a licence), certification (issuing a certificate) or registration.

b. The term authorization is also sometimes used to describe the document granting such permission.

c. In nuclear security, the governmental body concerned will be a competent authority, and the definition is set out in Nuclear Security Series publications as “The granting by a competent authority of written permission for operation of an associated facility or for carrying out an associated activity [or a document granting such permission]” [Nuclear Security Recommendations on Radioactive Material and Associated Facilities, IAEA Nuclear Security Series No. 14, IAEA, Vienna (2011), Nuclear Security Recommendations on Nuclear and Other Radioactive Material out of Regulatory Control, IAEA Nuclear Security Series No. 15, IAEA, Vienna (2011), Objective and Essential Elements of a State’s Nuclear Security Regime, IAEA Nuclear Security Series No. 20, IAEA, Vienna (2013)].

d. Authorization is generally a more formal process than approval. In context of the Transport Regulations [INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018).] approval is specific type of authorization concerning the items listed in para. 802 of the Transport Regulations that is carried out in accordance with the applicable requirements of the Transport Regulations.

e. See also approval: multilateral approval and unilateral approval.

Definition

1. An examination, observation, surveillance, measurement or test undertaken to assess structures, systems and components and materials, as well as operational activities, technical processes, organizational processes, procedures and personnel competence.

Definition

The application by a regulatory body of sanctions against an operator, intended to correct and, as appropriate, penalize non-compliance with conditions of an authorization.

Definition

A set of interrelated or interacting elements (system) for establishing policies and objectives and enabling the objectives to be achieved in an efficient and effective manner.

Scope notes

a. The component parts of the management system include the organizational structure, resources and organizational processes.

b. Management is defined (in ISO 9000) [INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Quality Management Systems — Fundamentals and Vocabulary, ISO 9000:2015, ISO, Geneva (2015).] as coordinated activities to direct and control an organization.

c. The management system integrates all elements of an organization into one coherent system to enable all of the organization’s objectives to be achieved. These elements include the organizational structure, resources and processes.

d. Personnel, equipment and organizational culture as well as the documented policies and processes form parts of the management system.

e. The organization’s processes have to address the totality of the requirements on the organization as established in, for example, IAEA safety standards and other international codes and standards.

Definition

Protection and conservation of: non-human species, both animal and plant, and their biodiversity; environmental goods and services such as the production of food and feed; resources used in agriculture, forestry, fisheries and tourism; amenities used in spiritual, cultural and recreational activities; media such as soil, water and air; and natural processes such as carbon, nitrogen and water cycles.

Scope notes

See also environment.

Definition

1. The prevention and detection of, and response to, criminal or intentional unauthorized acts involving nuclear material, other radioactive material, associated facilities or associated activities.

Scope notes

a. Often abbreviated to security in IAEA publications on nuclear security.

b. Security of nuclear material for reasons relating to non-proliferation of nuclear weapons is outside the scope of the IAEA safety standards and of the IAEA Nuclear Security Series.

e. The interaction between arrangements for security and arrangements for safety depends on the context. Areas in which arrangements for safety and arrangements for security interact include, for example: the regulatory infrastructure; engineering provisions in the design and construction of nuclear installations and other facilities; controls on access to nuclear installations and other facilities; the categorization of radioactive sources; source design; the security of the management of radioactive sources and radioactive material; the recovery of sources that are not under regulatory control; emergency response plans; and radioactive waste management.

d. There is not an exact distinction between the general terms safety and security. In general, security is concerned with intentional actions by people that could cause or threaten harm to other people; safety is concerned with the broader issue of harmful consequences to people (and to the environment) arising from exposure to radiation, whatever the cause.

c. Security of nuclear material for reasons relating to non-proliferation of nuclear weapons is outside the scope of the IAEA safety standards and of the IAEA Nuclear Security Series.

Definition

The assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, protection and safety issues receive the attention warranted by their significance.

Scope notes

For a more detailed discussion, see [INTERNATIONAL NUCLEAR SAFETY ADVISORY GROUP, Safety Culture, Safety Series No. 75-INSAG-4, IAEA, Vienna (1992).].

Definition

2. Activities carried out to determine whether requirements are met and processes are adequate and effective, and to encourage managers to implement improvements, including safety improvements.

Scope notes

a. This usage originated in quality assurance and related fields.

c. Assessment activities may include reviewing, checking, inspecting, testing, surveillance, auditing, peer evaluation and technical review. These activities can be divided into two broad categories: independent assessment and self-assessment.

b. Caution: The IAEA revised the requirements and guidance in the subject area of quality assurance for safety standards on management systems for the safety of facilities and activities involving the use of ionizing radiation. The terms quality management and management system have been adopted in the revised standards in place of the terms quality assurance and quality assurance programme.

Definition

Part of quality management intended to verify that structures, systems and components correspond to predetermined requirements.

Scope notes

This definition is taken from ISO 921:1997 (Nuclear Energy: Vocabulary) [INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Nuclear Energy: Vocabulary (Second Edition), ISO 921:1997, ISO, Geneva (1997).]. A more general definition of quality control and definitions of related terms can be found in ISO 8402:1994 [INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Quality Management and Quality Assurance — Vocabulary, ISO 8402:1994, ISO, Geneva (1994).].

Definition

The function of a management system that provides confidence that specified requirements will be fulfilled.

Scope notes

a. Caution: The IAEA revised the requirements and guidance in the subject area of quality assurance for its safety standards on management systems for the safety of facilities and activities involving the use of ionizing radiation.

c. Planned and systematic actions are necessary to provide adequate confidence that an item, process or service will satisfy given requirements for quality; for example, those specified in the licence.

d. This statement was slightly modified from that in the International Organization for Standardization’s publication ISO 921:1997 [INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Nuclear Energy: Vocabulary (Second Edition), ISO 921:1997, ISO, Geneva (1997).] to say ‘an item, process or service’ instead of ‘a product or service’ and to add the example.

e. A more general definition of quality assurance (all those planned and systematic actions necessary to provide confidence that a structure, system or component will perform satisfactorily in service) and definitions of related terms can be found in the International Organization for Standardization’s publication ISO 8402:1994 [INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Quality Management and Quality Assurance — Vocabulary, ISO 9000:2015, ISO, [INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Quality Management Systems — Fundamentals and Vocabulary, ISO 9000:2015, ISO, Geneva (2015)].

b. Caution: The terms quality management and management system were adopted in the revised standards in place of the terms quality assurance and quality assurance programme.

Definition

The total harm that would eventually be incurred by a group that is subject to exposure and by its descendants as a result of the group’s exposure to radiation from a source.

Scope notes

In its Publication 60 [INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, 1990 Recommendations of the ICRP, Publication 60, Pergamon Press, Oxford and New York (1991).], the International Commission on Radiological Protection defines a measure of radiation detriment that has the dimensions of probability, and that could therefore also be considered a measure of risk.

Definition

A governmental authority (at the national, regional or local level) that is responsible for policies and interventions, including the development of standards and the provision of guidance, for maintaining or improving human health, and that has the legal power of enforcing such policies and interventions.

Definition

A medical imaging procedure or therapeutic procedure that involves ionizing radiation - such as a procedure in diagnostic radiology, nuclear medicine or radiation therapy, or a planning procedure, image guided interventional procedure or other interventional procedure involving radiation - delivered by a radiation generator, a device containing a sealed source or an unsealed source, or by means of a radiopharmaceutical administered to a patient.

Definition

1. The process of determining what level of protection and safety would result in the magnitude of individual doses, the number of individuals (workers and members of the public) subject to exposure and the likelihood of exposure being as low as reasonably achievable, economic and social factors being taken into account (ALARA).

Definition

Any person who works, whether full time, part time or temporarily, for an employer and who has recognized rights and duties in relation to occupational radiation protection.

Scope notes

A self-employed person is regarded as having the duties of both an employer and a worker.

Definition

Persons who willingly and voluntarily help (other than in their occupation) in the care, support and comfort of patients undergoing radiological procedures for medical diagnosis or medical treatment.

Definition

The process of determining what level of protection and safety would result in the magnitude of individual doses, the number of individuals (workers and members of the public) subject to exposure and the likelihood of exposure being as low as reasonably achievable (ALARA), economic and social factors being taken into account.

Scope notes

Caution: The acronym ALARA should not be used to mean optimization of protection and safety.

See optimization of protection and safety.

Definition

2. Absorbed dose, committed equivalent dose, committed effective dose, equivalent dose, effective dose or organ dose, as indicated by the context.

Definition

A situation of exposure that arises from the planned operation of a source or from a planned activity that results in an exposure due to a source.

Scope notes

Since provision for protection and safety can be made before embarking on the activity concerned, associated exposures and their probabilities of occurrence can be restricted from the outset.

The primary means of controlling exposure in planned exposure situations is by good design of installations, equipment and operating procedures. In planned exposure situations, a certain level of exposure is expected to occur.

Definition

Exposure of workers incurred in the course of their work.

Definition

Exposure incurred by members of the public due to sources in planned exposure situations, emergency exposure situations and existing exposure situations, excluding any occupational exposure or medical exposure.

Definition

Loss of the ability of a structure, system or component to function within acceptance criteria.

Scope notes

a. Caution: Note that the structure, system or component is considered to fail when it becomes incapable of functioning, whether or not this is needed at that time.

b. Caution: A failure in, for example, a backup system may not be manifest until the system is called upon to function, either during testing or on failure of the system it is backing up.

c. A failure may be the result of, for example, a hardware fault, a software fault, a system fault, an operator error or a maintenance error.

Definition

An emergency in which there is, or is perceived to be, a hazard due to: (a) The energy resulting from a nuclear chain reaction or from the decay of the products of a chain reaction; or (b) Radiation exposure.

Scope notes

a. Points (a) and (b) approximately represent nuclear and radiological emergencies, respectively. However, this is not an exact distinction.

b. Radiation emergency is used in some cases when an explicit distinction in the nature of the hazard is immaterial (e.g. national radiation emergency plan), and it has essentially the same meaning.

Definition

A non-routine situation or eventthat necessitates prompt action, primarily to mitigate a hazard or adverse consequences for human life, health, property and the environment.

Scope notes

a. This includes nuclear and radiological emergencies and conventional emergencies such as fires, release of hazardous chemicals, storms or earthquakes.

b. It includes situations for which prompt action is warranted to mitigate the effects of a perceived hazard.

c. All terms and definitions relating to an emergency are taken from [FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL CIVIL AVIATION ORGANIZATION, INTERNATIONAL LABOUR ORGANIZATION, INTERNATIONAL MARITIME ORGANIZATION, INTERPOL, OECD NUCLEARENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, PREPARATORY COMMISSION FOR THE COMPREHENSIVE NUCLEAR-TESTBAN TREATY ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, UNITED NATIONS OFFICE FOR THE COORDINATION OF HUMANITARIAN AFFAIRS, WORLD HEALTH ORGANIZATION, WORLD METEOROLOGICAL ORGANIZATION, Preparedness and Response for a Nuclear or Radiological Emergency, IAEA Safety Standards Series No. GSR Part 7, IAEA, Vienna (2015).].

Definition

This term encompasses the sub-terms planned exposure situation, emergency exposure situation and existing exposure situation.

Scope notes

Caution: The exposure situation is indicated by the circumstances of exposure of the individual(s) undergoing exposure; it cannot be used to characterize a jurisdiction or the geographical area, for example, although for practical purposes such generalizations are sometimes assumed.

Three broad exposure situations were used as the basis for organizing the safety requirements established in the Basic Safety Standards [EUROPEAN COMMISSION, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, IAEA Safety Standards Series No. GSR Part 3, IAEA, Vienna (2014).]. The characterizations in terms of ‘situations’ (which derive from [INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, The 2007 Recommendations of the International Commission on Radiological Protection, Publication 103, Ann. ICRP 37 2–4, Elsevier Science, Oxford (2007).]) are not clearly delineated or conceptually distinct and the descriptions of the three types of exposure situation are not always sufficient to determine unequivocally which type of exposure situation applies for particular circumstances. In the safety standards, the most appropriate type of exposure situation for particular circumstances is determined by taking practical considerations into account..

Definition

A situation of exposure that arises as a result of an accident, a malicious act or other unexpected event, and requires prompt action in order to avoid or to reduce adverse consequences.

Scope notes

b. Exposure in an emergency can be reduced only by protective actions and other response actions.

a. Exposure in an emergency can include both occupational exposure and public exposure, and can include unplanned exposures resulting directly in the emergency exposure situation and planned exposures to emergency workers and helpers in an emergency undertaking actions to mitigate the consequences of the emergency.

Definition

A situation of exposure that already exists when a decision on the need for control needs to be taken.

Scope notes

Existing exposure situations include exposure to natural background radiation that is amenable to control; exposure due to residual radioactive material that derives from past practices that were never subject to regulatory control; and exposure due to residual radioactive material deriving from a nuclear or radiological emergency after an emergency has been declared to be ended. See para. 5.1 and Requirement 52 of GSR Part 3 (EUROPEAN COMMISSION, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, IAEA Safety Standards Series No. GSR Part 3, IAEA, Vienna (2014)).

Definition

All activities performed to achieve the purpose for which an authorized facility was constructed.

Scope notes

c. See also abnormal operation and normal operation.

a. For a nuclear power plant, this includes maintenance, refuelling, in-service inspection and other associated activities.

b. The terms siting, design, construction, commissioning, operation and decommissioning are normally used to delineate the six major stages of the lifetime of an authorized facility and of the associated licensing process. In the special case of disposal facilities for radioactive waste, decommissioning is replaced in this sequence by closure.

<h2>Definition</h2>In the context of the reporting and analysis of events, an event is any occurrence unintended by the operator, including operating error, equipment failure or other mishap, and deliberate action on the part of others, the consequences or potential consequences of which are not negligible from the point of view of protection and safety.<h2>Scope notes</h2><ul><li>c. This difference derives from the fact that event reporting and analysis is concerned directly with the question of whether an event that could develop into an accident with significant consequences actually does so; terms such as accident are used only to describe the end result and therefore other terms are needed to describe the earlier stages. See also initiating event and initiating event: postulated initiating event.</li><li>a. Caution: As with INES, the terminology related to the reporting and analysis of events is not consistent with the terminology used in safety standards, and great care should be taken to avoid confusion.</li><li>b. Caution: In particular, the definition of event given above is identical in essence to the safety standards definition (1) of accident.</li><li>d. Event is also used in the phrase ‘features, events and processes’ associated with the site and the facility in the context of site characterization for a disposal facility for radioactive waste.</li><li>e. Relevant features, events and processes relating to the site are those that might influence the long term performance of the disposal facility and thus could affect safety. These are addressed in a safety case and in a supporting safety assessment. Types of events and circumstances <img src="https://nucleus.iaea.org/sites/nss-oui/Figures/i_8c833feb-4169-44c2-969e-a4337573ef03.JPG " style="width: 480px;"></li></ul>

Definition

Prospectively considered Exposure considered, that is not expected to be incurred with certainty but that may potentially result from an anticipated operational occurrence or accident at a source or owing to an event or sequence of events of a probabilistic nature, including equipment failures and operating errors.

Scope notes

b. Potential exposure is considered within planned exposure situation.

a. Caution: Potential exposure is not an exposure and is not a type of exposure.

d. In the case of a geological disposal facility, assessment of the long term action of processes and events that are uncertain leads to projections of long term potential exposure.

c. Potential exposure includes prospectively considered (i.e. hypothetical or postulated) exposures due to a source in an event or sequence of events of a probabilistic nature, including exposures resulting from an accident, equipment failures, operating errors, natural events or phenomena (such as hurricanes, earthquakes and floods) and inadvertent human intrusion (such as a human intrusion into a near surface disposal facility after institutional control is removed).

Definition

Immediate action by the operator or other party:
(1) To reduce the potential for conditions to develop that would result in exposure or a release of radioactive material requiring emergency response actions on the site or off the site; or
(2) To mitigate source conditions that may result in exposure or a release of radioactive material requiring emergency response actions on the site or off the site

Definition

The doses, dose rates or activity concentrations associated with natural sources or any other sources in the environment that are not amenable to control.

Scope notes

This is normally considered to include doses, dose rates or activity concentrations associated with natural sources, global fallout (but not local fallout) from atmospheric nuclear weapon tests.

Definition

Any human activity that introduces additional sources of exposure or additional exposure pathways, or that modifies the network of exposure pathways from existing sources, so as to increase the exposure or the likelihood of exposure of people or the number of people exposed.

Scope notes

b. The term facilities and activities is intended to provide an alternative to the terminology of sources and practices (or interventions) to refer to general categories of situations.

c. Terms such as ‘authorized practice’, ‘controlled practice’ and ‘regulated practice’ are used to distinguish those practices that are subject to regulatory control from other activities that meet the definition of a practice but do not need or are not amenable to control.

a. Caution: Radioactive waste is generated as a result of practices that involve some beneficial effect, such as the generation of electricity by nuclear means or the diagnostic application of radioisotopes. The management of this waste is therefore only one part of the overall practice.

Definition

2. [Any form of control or regulation applied to facilities or activities by a regulatory body for reasons relating to radiation protection or to the safety or security of radioactive sources.] (From Code of Conduct on the Safety and Security of Radioactive Sources, IAEA, Vienna (2004).)

Scope notes

Caution: This definition is particular to the Code of Conduct on the Safety and Security of Radioactive Sources [Code of Conduct on the Safety and Security of Radioactive Sources, IAEA, Vienna (2004).].

Definition

1. The process, and the result, of analysing systematically and evaluating the hazards associated with sources and practices, and associated protection and safety measures.

Scope notes

Assessment is often aimed at quantifying performance measures for comparison with criteria.

In IAEA publications, assessment should be distinguished from analysis. Assessment is aimed at providing information that forms the basis of a decision on whether or not something is satisfactory. Various kinds of analysis may be used as tools in doing this. Hence an assessment may include a number of analyses.

Definition

A prospective and source related value of individual dose that is used in planned exposure situations as a parameter for the optimization of protection and safety for the source, and that serves as a boundary in defining the range of options in optimization.

Scope notes

c. The dose constraint for each particular source is intended, among other things, to ensure that the sum of doses from planned operations for all sources under control remains within the dose limit.

a. For occupational exposure, the dose constraint is a constraint on individual dose to workers established and used by registrants and licensees to set the range of options in optimizing protection and safety for the source.

b. For public exposure, the dose constraint is a source related value established or approved by the government or the regulatory body, with account taken of the doses from planned operations of all sources under control.

d. For medical exposure, the dose constraint is a source related value used in optimizing the protection of carers and comforters of patients undergoing radiological procedures, and the protection of volunteers subject to exposure as part of a programme of biomedical research.

Definition

For an emergency exposure situation or an existing exposure situation, the level of dose, risk or activity concentration above which it is not appropriate to plan to allow exposures to occur and below which optimization of protection and safety would continue to be implemented.

Scope notes

The value chosen for a reference level will depend upon the prevailing circumstances for the exposure under consideration.

Definition

1. Any combination of isotopes of the element radon.

Scope notes

For the purposes of the IAEA safety standards, radon refers to ²²⁰Rn and ²²²Rn.

Definition

The dose from external exposure in a year plus the committed dose from intakes of radionuclides in that year.

Scope notes

a. The individual dose, unless otherwise stated.

b. Caution: This is not, in general, the same as the dose actually delivered during the year in question, which would include doses from radionuclides remaining in the body from intakes in previous years, and would exclude doses delivered in future years from intakes of radionuclides during the year in question.

Definition

For purposes of protection and safety, in a general sense, any individual in the population except when subject to occupational exposure or medical exposure. For the purpose of verifying compliance with the annual dose limit for public exposure, this is the representative person.

Definition

The dose expected to be incurred after protective actions have been terminated (or after a decision has been taken not to take protective actions).

Scope notes

Residual dose applies for an emergency exposure situation or for an existing exposure situation.

Definition

A person having specified duties as a worker in response to an emergency.

Scope notes

Emergency workers may include workers employed, both directly and indirectly, by registrants and licensees, as well as personnel of response organizations, such as police officers, firefighters, medical personnel, and drivers and crews of vehicles used for evacuation.

Emergency workers may or may not be designated as such in advance of an emergency. Emergency workers not designated as such in advance of an emergency are not necessarily workers prior to the emergency.

Definition

The time integral over the activity concentration of radon for a defined period of time. Exposure due to radon is a measurand related to the potential alpha energy exposure with the equilibrium factor taken into account and is, therefore, related to the effective dose.

Definition

A level used in medical imaging to indicate whether, in routine conditions, the dose to the patient or the amount of radiopharmaceuticals administered in a specified radiological procedure for medical imaging is unusually high or unusually low for that procedure [EUROPEAN COMMISSION, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, IAEA Safety Standards Series No. GSR Part 3, IAEA, Vienna (2014).].

Scope notes

For the use of radiopharmaceuticals, the diagnostic reference level is a level of activity for typical examinations for groups of standardized patients or for a standard phantom and for broadly defined types of equipment.

The diagnostic reference levels are indicative of good practice, when not exceeded, for standard procedures in which good practices and normal practices are applied with regard to diagnostic performance and technical performance.

Definition

1. The quantity A for an amount of radionuclide in a given energy state at a given time, defined as
A(t) = dN / dt
where dN is the expectation value of the number of spontaneous nuclear transformations from the given energy state in the time interval dt.

Scope notes

b. The SI unit for activity is reciprocal second (s^–1), termed the becquerel (Bq).

c. Formerly expressed in [curie] (Ci); activity values may be given in Ci (with the equivalent in Bq in parentheses) if they are being quoted from a reference that uses Ci as the unit.

a. The rate at which nuclear transformations occur in a radioactive material. The equation is sometimes given as:
A(t) = dN / dt
where N is the number of nuclei of the radionuclide, and hence the rate of change of N with time is negative. Numerically, the two forms are identical.

Definition

Any action that might be taken, condition that might be applied or procedure that might be followed to fulfil the requirements of Safety Requirements.

Definition

1. Any nuclear facility subject to authorization that is part of the nuclear fuel cycle, except facilities for the mining or processing of uranium ores or thorium ores and disposal facilities for radioactive waste.

Scope notes

b. For safeguards purposes, see the definition of nuclear installations in the Safeguards Glossary [IAEA Safeguards Glossary (2022 Edition), IAEA, Vienna].

a. This definition thus includes: nuclear power plants; research reactors (including subcritical and critical assemblies) and any adjoining radioisotope production facilities; storage facilities for spent fuel; facilities for the enrichment of uranium; nuclear fuel fabrication facilities; conversion facilities; facilities for the reprocessing of spent fuel; facilities for the predisposal management of radioactive waste arising from nuclear fuel cycle facilities; and nuclear fuel cycle related research and development facilities.

Definition

This term encompasses medical exposure, occupational exposure and public exposure.

Definition

Any measures that may be carried out to reduce the radiation exposure due to existing contamination of land areas through actions applied to the contamination itself (the source) or to the exposure pathways to humans.

Scope notes

a. Complete removal of the contamination is not implied.

b. The use of the terms cleanup, rehabilitation and restoration as synonyms for remediation is discouraged. Such terms may be taken to imply that the conditions that prevailed before the contamination can be achieved again and unconditional use of the land areas can be restored, which is not usually the case (e.g. owing to the effects of the remedial action itself). Often remediation is used to restore land areas to conditions suitable for limited use under institutional control.

f. See also decontamination.

e. The term cleanup is used in the context of decommissioning.

d. In some contexts (e.g. the wider chemical industry), the terms remediation and restoration are used to describe different parts of overall recovery.

c. Remediation can entail activities that are similar to decommissioning; both remediation and decommissioning activities are typically performed under an authorization. Abandoned and presently unauthorized industrial sites, such as former uranium mines and mills and former radium processing facilities, may have buildings and structures that are taken down by actions consistent with the decommissioning process (e.g. decontamination and dismantling); however, such activities are considered to be a part of site remediation.

Definition

The determination by a regulatory body that a source or practice need not be subject to some or all aspects of regulatory control on the basis that the exposure and the potential exposure due to the source or practice are too small to warrant the application of those aspects or that this is the optimum option for protection irrespective of the actual level of the doses or risks.

Scope notes

For exemption from IAEA safeguards, see the Safeguards Glossary [INTERNATIONAL ATOMIC ENERGY AGENCY, IAEA Safeguards Glossary (2022 Edition), IAEA, Vienna.].

Definition

1. Removal of regulatory control by the regulatory body from radioactive material or radioactive objects within notified or authorized facilities and activities.

Scope notes

a. Removal from regulatory control in this context refers to regulatory control applied for radiation protection purposes.

b. Conceptually, clearance — freeing certain materials or objects in authorized facilities and activities from further control — is closely linked to, but distinct from and not to be confused with, exemption — determining that controls do not need to be applied to certain sources and facilities and activities.

c. Various terms (e.g. ‘free release’) are used in different States to describe this concept.

d. A number of issues relating to the concept of clearance and its relationship to other concepts were resolved in [INTERNATIONAL ATOMIC ENERGY AGENCY, Application of the Concepts of Exclusion, Exemption and Clearance, IAEA Safety Standards Series No. RS-G-1.7, IAEA, Vienna (2004).].

Definition

A radioactive source in which the radioactive material is (a) permanently sealed in a capsule or (b) closely bonded and in a solid form.

Scope notes

a. The Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management definition [Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management, INFCIRC/546, IAEA, Vienna (1997).] is “radioactive material that is (a) permanently sealed in a capsule or (b) closely bonded and in a solid form, excluding reactor fuel elements.

b. The term special form radioactive material, used in the context of transport of radioactive material, has essentially the same meaning.

d. Disused sealed source: see source: disused source.

c. Definition 2 of radioactive source, which is taken from the Code of Conduct on the Safety and Security of Radioactive Sources [Code of Conduct on the Safety and Security of Radioactive Sources, IAEA/CODEOC/2004, IAEA, Vienna (2004).], has essentially the same meaning.

Definition

The removal of a source or the reduction of its magnitude (in terms of activity or amount) for the purposes of preventing or reducing exposures that might otherwise occur in an emergency or in an existing exposure situation.

Scope notes

Remedial actions could also be termed protective actions, but protective actions are not necessarily remedial actions.

See also remediation and protective action.

Definition

A person, company, etc., with a concern or interest in the activities and performance of an organization, business, system, etc.

Scope notes

a. The term interested party is used in a broad sense to mean a person or group having an interest in the performance of an organization.

b. Those who can influence events may effectively become interested parties — whether their ‘interest’ is regarded as ‘genuine’ or not — in the sense that their views need to be considered.

c. Interested parties would need to be specified as relevant.

e. Caution: The term [stakeholder] is used in the same broad sense as interested party and the same provisos are necessary.

f. Caution: The term [stakeholder] has disputed usage, and it is misleading and too all-encompassing for clear use. In view of the potential for misunderstanding and misrepresentation, use of the term is discouraged in favour of interested party.

g. The Handbook on Nuclear Law [INTERNATIONAL ATOMIC ENERGY AGENCY, Handbook on Nuclear Law, IAEA, Vienna (2003).] states that: “Owing to the differing views on who has a genuine interest in a particular nuclear related activity, no authoritative definition of [stakeholder] has yet been offered, and no definition is likely to be accepted by all parties.”

d. Interested parties have typically included the following: customers, owners, operators, employees, suppliers, partners and trade unions; the regulated industry or professionals; scientific bodies; governmental agencies or regulatory bodies (national, regional and local) whose responsibilities may cover nuclear energy; the media; the public (individuals, community groups and interest groups); and other States, especially neighbouring States that have entered into agreements providing for an exchange of information concerning possible transboundary impacts, or States involved in the export or import of certain technologies or materials. [INTERNATIONAL ATOMIC ENERGY AGENCY, Handbook on Nuclear Law, IAEA, Vienna (2003).]

Definition

1. For a system of control, such as a regulatory system or a safety system, a process or method in which the stringency of the control measures and conditions to be applied is commensurate, to the extent practicable, with the likelihood and possible consequences of, and the level of risk associated with, a loss of control.

Scope notes

An example of a graded approach in general would be a structured method by means of which the stringency of application of requirements is varied in accordance with the circumstances, the regulatory systems used, the management systems used, etc.

For example, a method in which: (1) The significance and complexity of a product or service are determined; (2) The potential impacts of the product or service on health, safety, security, the environment, and the achieving of quality and the organization’s objectives are determined; (3) The consequences if a product fails or if a service is carried out incorrectly are taken into account.

The use of a graded approach is intended to ensure that the necessary levels of analysis, documentation and actions are commensurate with, for example, the magnitudes of any radiological hazards and non-radiological hazards, the nature and the particular characteristics of a facility, and the stage in the lifetime of a facility.

Definition

These include: the production, use, import and export of radiation sources for industrial, research and medical purposes; the transport of radioactive material; the decommissioning of facilities; radioactive waste management activities such as the discharge of effluents; the remediation of sites affected by residues from past activities.

Scope notes

The term facilities and activities is very general, and includes those for which little or no regulatory control may be necessary or achievable: the more specific terms authorized facility and authorized activity should be used to distinguish those facilities and activities for which any form of authorization has been given.

Definition

An individual who, by virtue of certification by appropriate boards or societies, professional licence or academic qualifications and experience, is duly recognized as having expertise in a relevant field of specialization, for example medical physics, radiation protection, occupational health, fire safety, quality management or any relevant engineering or safety speciality.

Definition

The measurement of external dose rates due to sources in the environment or of radionuclide concentrations in environmental media.

Scope notes

Contrasted with source monitoring.

Definition

A set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards.

Scope notes

b. A calibration may be expressed by a statement, calibration function, calibration diagram, calibration curve or calibration table. In some cases, it may consist of an additive or multiplicative correction of the indication with associated measurement uncertainty.

c. Calibration should not be confused with adjustment of a measuring system, often mistakenly called ‘self-calibration’, or with verification of calibration.

a. The definition was previously “A measurement of, or adjustment to, an instrument, component or system to ensure that its accuracy or response is acceptable”.

Definition

1. Administrative and technical actions taken to allow the removal of some or all of the regulatory controls from a facility.

Scope notes

Note: The terms siting, design, construction, commissioning, operation and decommissioning are normally used to delineate the six major stages of the lifetime of an authorized facility and of the associated licensing process. In the special case of disposal facilities for radioactive waste, decommissioning is replaced in this sequence by closure.

a. Caution: This does not apply for that part of a disposal facility in which radioactive waste is emplaced, or for certain facilities used for the disposal of naturally occurring radioactive material (NORM) or of residues from the mining and processing of radioactive ores. For all of these the term closure is used instead of decommissioning.

b. Caution: Decommissioning typically includes dismantling of the facility (or part thereof) to reduce the associated radiation risks, but in the IAEA’s usage this need not be the case. A facility could, for example, be decommissioned without dismantling and the existing structures subsequently put to another use (after decontamination).

c. The use of the term decommissioning implies that no further use of the facility (or part thereof) for its existing purpose is foreseen.

d. Actions for decommissioning are taken at the end of the operating lifetime of a facility to retire it from service with due regard for the health and safety of workers and members of the public and protection of the environment.

e. Subject to national legal and regulatory requirements, a facility (or its remaining parts) may also be considered decommissioned if it is incorporated into a new or existing facility, even if the site on which it is located is still under regulatory control or institutional control.

f. The actions will need to be such as to ensure the long term protection of the public and protection of the environment, and typically include reducing the levels of residual radionuclides in the materials and on the site of the facility so that the materials can be safely recycled, reused or disposed of as exempt waste or as radioactive waste and the site can be released for unrestricted use or otherwise reused.

g. Decommissioning can entail activities that are similar to remediation (also an authorized process), such as removal of contaminated soil from an area within the authorized boundary of a facility, but in this case, such removals are normally referred to as cleanup activities and are typically performed under the authorization for decommissioning.

Definition

1. Nuclear fuel removed from a reactor following irradiation that is no longer usable in its present form because of depletion of fissile material, poison buildup or radiation damage.

Scope notes

The participle ‘spent’ suggests that spent fuel cannot be used as fuel in its present form (e.g. as in spent source). In practice, however (as in (2) below), spent fuel is commonly used to refer to fuel that has been used as fuel but will no longer be used, whether or not it could be used (and that might more accurately be termed ‘disused fuel’).

Definition

1. The deliberate physical movement of radioactive material (other than that forming part of the means of propulsion) from one place to another.

Scope notes

a. The term transportation is also used, in particular in US English or where there is a need to distinguish this meaning of transport from meaning (2).

c. In some Nuclear Security Series publications addressing transport of nuclear material, transport has also been defined as “International or domestic carriage of nuclear material by any means of transport, beginning with the departure from a nuclear facility of the shipper and ending with the arrival at a nuclear facility of the receiver” [Nuclear Security Recommendations on Physical Protection of Nuclear Material and Nuclear Facilities, INFCIRC/225/Revision 5, IAEA Nuclear Security Series No. 13, IAEA, Vienna (2011)].

b. In the context of the Transport Regulations, transport comprises all operations and conditions associated with, and involved in, the movement of radioactive material; these include the design, manufacture, maintenance and repair of packaging, and the preparation, consigning, loading, carriage including in-transit storage, shipment after storage, unloading and receipt at the final destination of loads of radioactive material and packages.

Definition

An examination or review of commercial, professional or academic efficiency, competence, etc., by others in the same occupation.

Scope notes

Peer review is also: the evaluation, by experts in the relevant field, of a scientific research project for which a grant is sought; the process by which a learned journal passes a paper received for publication to outside experts for their comments on its suitability and worth; refereeing.

Definition

1. A document submitted to the regulatory body by a person or organization to notify an intention to carry out a practice or other use of a source.

Scope notes

This includes the notification of appropriate competent authorities by a consignor that a shipment will pass ‘through or into’ their countries, as required in section V of the Transport Regulations [INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018)].

Definition

The cessation of operation of a facility.

Definition

1. Administrative and technical actions directed at a disposal facility at the end of its operating lifetime — for example, covering of the disposed waste (for a near surface disposal facility) or backfilling and/or sealing (for a geological disposal facility and the passages leading to it) — and the termination and completion of activities in any associated structures.

Scope notes

For other types of facilities, the term decommissioning is used.

The terms siting, design, construction, commissioning, operation and decommissioning are normally used to delineate the six major stages of the lifetime of an authorized facility and of the associated licensing process. In the special case of disposal facilities for radioactive waste, decommissioning is replaced in this sequence by closure.

Definition

The holder of a current registration is termed a registrant. Other derivative terms should not be needed; a registration is a product of the authorization process, and a facility or activity with a current registration is an authorized facility or activity.
See registration.

Definition

The holder of a current licence.

Scope notes

The licensee is the person or organization having overall responsibility for a facility or activity.

Definition

A person or organization with recognized responsibilities, commitments and duties towards a worker in the employment of the person or organization by virtue of a mutually agreed relationship.

Scope notes

Caution: A self-employed person is regarded as being both an employer and a worker.

Definition

A device or manufactured item into which radionuclides have deliberately been incorporated or produced by activation, or which generates ionizing radiation, and which can be sold or made available to members of the public without special surveillance or regulatory control after sale.

Scope notes

Consumer products include items such as smoke detectors and luminous dials into which radionuclides have deliberately been incorporated and ion generating tubes. It does not include building materials, ceramic tiles, spa waters, minerals and foodstuffs, and it excludes products and appliances installed in public places (e.g. tritium exit signs).

Definition

A person technically competent in radiation protection matters relevant for a given type of practice who is designated by the registrant, licensee or employer to oversee the application of relevant requirements.

Definition

A health professional who, in accordance with national requirements, may refer individuals to a radiological medical practitioner for medical exposure.

Definition

A health professional with specialist education and training in the concepts and techniques of applying physics in medicine and competent to practise independently in one or more of the subfields (specialties) of medical physics.

Scope notes

Competence of persons is normally assessed by the State by having a formal mechanism for registration, accreditation or certification of medical physicists in the various specialties (e.g. diagnostic radiology, radiation therapy, nuclear medicine).

States that have yet to develop such a mechanism would need to assess the education, training and competence of any individual proposed by the licensee to act as a medical physicist and to decide, on the basis of either international accreditation standards or standards of a State where such an accreditation system exists, whether such an individual could undertake the functions of a medical physicist, within the required specialty.

Definition

A health professional, with specialist education and training in medical radiation technology, competent to perform radiological procedures, on delegation from the radiological medical practitioner, in one or more of the specialties of medical radiation technology.

Scope notes

Competence of persons is normally assessed by the State by having a formal mechanism for registration, accreditation or certification of medical radiation technologists in the various specialties (e.g. diagnostic radiology, radiation therapy, nuclear medicine).

States that have yet to develop such a mechanism would need to assess the education, training and competence of any individual proposed by the licensee to act as a medical radiation technologist and to decide, on the basis of either international standards or standards of a State where such a system exists, whether such an individual could undertake the functions of a medical radiation technologist, within the required specialty.

Definition

Process of determining whether a system or component is suitable for operational use.

Scope notes

a. Qualification is generally performed in the context of a specific set of qualification requirements for the specific facility and class of system and for the specific application.

c. Qualification may rely on activities performed outside the framework of a specific facility design (this is called ‘generic qualification’ or ‘prequalification’).

d. Prequalification may significantly reduce the necessary effort in facility specific qualification; however, the application specific qualification requirements must still be met and be shown to be met.

b. Qualification may be accomplished in stages: for example, first, by the qualification of pre-existing equipment (usually early in the system realization process), then, in a second step, by the qualification of the integrated system (i.e. in the final realized design).

e. See also harsh environment, mild environment.

Definition

2. An evaluation of the conformity to a requirement.

Definition

A system important to safety, provided to ensure the safe shutdown of the reactor or the residual heat removal from the reactor core, or to limit the consequences of anticipated operational occurrences and design basis accidents.

Scope notes

a. Safety systems consist of the protection system, the safety actuation systems and the safety system support features.

b. Components of safety systems may be provided solely to perform safety functions, or may perform safety functions in some plant operational states and non-safety functions in other operational states.

Definition

A radioactive source in which the radioactive material is neither (a) permanently sealed in a capsule nor (b) closely bonded and in a solid form.

Definition

All operations associated with the production of nuclear energy.

Scope notes

Operations in the nuclear fuel cycle associated with the production of nuclear energy include the following:
(a) Mining and processing of uranium ores or thorium ores;
(b) Enrichment of uranium;
(c) Manufacture of nuclear fuel;
(d) Operation of nuclear reactors (including research reactors);
(e) Reprocessing of spent fuel;
(f) All waste management activities (including decommissioning) relating to operations associated with the production of nuclear energy;
(g) Any related research and development activities.

Definition

1. Planned and controlled release of (usually gaseous or liquid) radioactive substances to the environment.

Scope notes

Strictly, the act or process of releasing the radioactive substances, but also used to describe the radioactive substances released.

Definition

The process of selecting a suitable site for a facility, including appropriate assessment and definition of the related design bases.

Scope notes

The siting process for a nuclear installation generally consists of site survey and site selection.

The terms siting, design, construction, commissioning, operation and decommissioning are normally used to delineate the six major stages of the lifetime of an authorized facility and of the associated licensing process. In the special case of disposal facilities for radioactive waste, decommissioning is replaced in this sequence by closure.

Definition

A medical facility in which radiological procedures are performed.

Definition

Radionuclides that occur naturally on Earth in significant quantities.

Scope notes

c. Caution: Radionuclides of artificial origin may include radionuclides that are also naturally occurring but may not include radionuclides of natural origin.

b. Contrasted with radionuclides of artificial origin, anthropogenic radionuclides and human made radionuclides (which all mean the same), and also with artificial radionuclides (which exclude radionuclides of artificial origin that are also naturally occurring).

a. The term is usually used to refer to the primordial radionuclides ⁴⁰K, ²³⁵U, ²³⁸U, ²³²Th and their radioactive decay products.

Definition

Any single material or multiple materials, whether processed, semi-processed or raw, that is or are intended to be fed directly to food producing animals.

Definition

This term encompasses sub-terms such as depleted uranium, enriched uranium, high enriched uranium, low enriched uranium and natural uranium

Definition

An action on a non-conforming product to make it acceptable for its intended use (see ISO 9000:2015, INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Quality Management Systems — Fundamentals and Vocabulary, ISO 9000:2015, ISO, Geneva (2015).).

Definition

2. The movement of something as a result of being carried by a medium.

Scope notes

A general term used when a number of different processes are involved. The most common examples are heat transport — a combination of advection, convection, etc., in a cooling medium — and radionuclide transport in the environment — which could include processes such as advection, diffusion, sorption and uptake.

Definition

2. An application of safety requirements that is commensurate with the characteristics of the facilities and activities or the source and with the magnitude and likelihood of the exposures.

Scope notes

See also exclusion, exemption, clearance and optimization.

Definition

The value of a quantity used in certain specified activities or circumstances that must not be exceeded.

Scope notes

a. Caution: The term limit should only be used for a criterion that must not be exceeded; for example, where exceeding the limit would cause some form of legal sanction to be invoked.

b. Caution: Criteria used for other purposes — for example, to indicate a need for closer investigation or a review of procedures, or as a threshold for reporting to a regulatory body — should be described using other terms, such as reference level.

Definition

The organized activity, both administrative and technical, of keeping structures, systems and components in good operating condition, including both preventive and corrective (or repair) aspects.

Definition

1. Emplacement of waste in an appropriate facility without the intention of retrieval.

Scope notes

c. Caution: In IAEA publications, disposal should be used only in accordance with the more restrictive definition given above.

d. Caution: In many cases, the only element of this definition that is important is the distinction between disposal (with no intent to retrieve) and storage (with intent to retrieve). In such cases, a definition is not necessary; the distinction can be made in the form of a footnote at the first use of the term disposal or storage (e.g. “The use of the term ‘disposal’ indicates that there is no intention to retrieve the waste. If retrieval of the waste at any time in the future is intended, the term ‘storage’ is used.”).

e. Caution: The term disposal implies that retrieval is not intended and would require deliberate action to regain access to the waste; it does not mean that retrieval is not possible.

g. Contrasted with storage.

f. For storage in a combined storage and disposal facility, for which a decision may be made at the time of its closure whether to remove the waste stored during the operation of the storagefacility or to dispose of it by encasing it in concrete, the question of intention of retrieval may be left open until the time of closure of the facility.

b. In some States, the term disposal is used administratively in such a way as to include, for example, incineration of waste or the transfer of waste between operators.

a. In some States, the term disposal is used to include discharges of effluents to the environment.

Definition

A form of authorization for facilities and activities of low or moderate risks whereby the person or organization responsible for the practice has, as appropriate, prepared and submitted a safety assessment of the facilities and equipment to the regulatory body. The practice or use is authorized with conditions or limitations as appropriate.

Scope notes

a. The requirements for safety assessment and the conditions or limitations applied to the facilities and activities would be less severe for registration than those for issuing a licence.

b. Typical facilities and activities that are amenable to registration are those for which: (a) safety can largely be ensured by the design of the facilities and equipment; (b) the operating procedures are simple to follow; (c) the safety training requirements are minimal; and (d) there is a history of few problems with safety in operations. Registration is best suited to those facilities and activities for which operations do not vary significantly.

c. See also registrant. Other derivative terms should not be needed; a registration is a product of the authorizationprocess, and a facility or activity with a current registration is an authorized facility or activity.

Definition

1. A legal document issued by the regulatory body granting authorization to perform specified activities relating to a facility or activity.

Scope notes

b. Authorization may take other forms, such as registration or certification.

a. A licence is a product of the authorization process (although the term licensing process is sometimes used), and a practice with a current licence is an authorized practice.

Definition

1. Assessment of all aspects of a practice that are relevant to protection and safety; for an authorized facility, this includes siting, design and operation of the facility.

Scope notes

b. See also probabilistic safety assessment (PSA)

a. This will normally include risk assessment (1).

Definition

A value, established by a regulatory body and expressed in terms of activity concentration, total activity, dose rate or radiation energy, at or below which a source of radiation need not be subject to some or all aspects of regulatory control.

Scope notes

a. A regulatory body may also grant exemption on a case by case basis, following notification.

b. Although the term exemption level does not strictly apply in such a situation, a criterion for exemption may nevertheless be established by the regulatory body, expressed in similar terms or, alternatively, expressed in terms of annual dose on the basis of an appropriate dose assessment. (See Ref. [EUROPEAN COMMISSION, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, IAEA Safety Standards Series No. GSR Part 3, IAEA, Vienna (2014).] and para. 5.12 of [INTERNATIONAL ATOMIC ENERGY AGENCY, Application of the Concepts of Exclusion, Exemption and Clearance, IAEA Safety Standards Series No. RS-G-1.7, IAEA, Vienna (2004).].)

c. Values of exemption levels are specified in Table I.1 and Table I.2 of schedule I of Ref. [EUROPEAN COMMISSION, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, IAEA Safety Standards Series No. GSR Part 3, IAEA, Vienna (2014).].

Definition

A value, established by a regulatory body and expressed in terms of activity concentration, at or below which regulatory control may be removed from a source of radiation within a notified or authorized practice.

Definition

A series of specified actions conducted in a certain order or manner.

Scope notes

The set of actions to be taken to conduct an activity or to perform a process is typically specified in a set of instructions.

Definition

1. The period during which an authorized facility is used for its intended purpose, until decommissioning or closure.

Scope notes

The synonyms operating period and operational period are also used.

Definition

Material for which no further use is foreseen.

Definition

Caution: The ‘scientific’ meaning of radioactive (1) — as in radioactive substance — refers only to the presence of radioactivity, and gives no indication of the magnitude of the hazard involved.
See radioactive (1), radioactive material (1).

Definition

1. The act or process of taking radionuclides into the body by inhalation or ingestion or through the skin.

Scope notes

Other exposure pathways by intake are injection (e.g. in nuclear medicine) and intake via a wound, as distinguished from intake through (intact) skin.

Definition

A prospective and source related value of individual dose (see dose constraint) or of individual risk (see risk constraint) that is used in planned exposure situations as a parameter for the optimization of protection and safety for the source, and that serves as a boundary in defining the range of options in optimization.

Definition

The dose incurred by an individual.

Scope notes

Contrasting term: collective dose.

Definition

2. The mathematical mean (expectation value) of an appropriate measure of a specified (usually unwelcome) consequence;
R = S_ip_i×C_i
where pi is the probability of occurrence of scenario or event sequence i and Ci is a measure of the consequence of that scenario or event sequence.

Scope notes

a. Typical consequence measures C_i include core damage frequency, the estimated number or probability of health effects, etc.

b. If the number of scenarios or event sequences is large, the summation is replaced by an integral.

c. Caution: The summing of risks associated with scenarios or event sequences with widely differing values of Ci is controversial. In such cases the use of the term ‘expectation value’, although mathematically correct, is misleading and should be avoided if possible.

d. Methods for treating uncertainty in the values of pand C— and in particular whether such uncertainty is represented as an element of risk itself or as uncertainty in estimates of risk — vary.

Definition

The quantity E, defined as a summation of the tissue or organ equivalent doses, each multiplied by the appropriate tissue weighting factor:
E = S_Tw_T . H_T
where H_T is the equivalent dose in tissue or organ T and w_T is the tissue weighting factor for tissue or organ T.
From the definition of equivalent dose, it follows that:
E = S_Tw_T . S_Rw_R . D_T,R
where w_R is the radiation weighting factor for radiation type R and D_T,R is the average absorbed dose in the tissue or organ T delivered by radiation type R.

Scope notes

b. The rem, equal to 0.01 Sv, is sometimes used as a unit of equivalent dose and effective dose. This should not be used in IAEA publications, except when quoting directly from other publications, in which case the value in sieverts should be added in parentheses.

c. Effective dose is a measure of dose designed to reflect the amount of radiation detriment likely to result from the dose.

d. Effective dose cannot be used to quantify higher doses or to make decisions on the need for any medical treatment relating to deterministic effects.

e. Values of effective dose from exposure for any type(s) of radiation and any mode(s) of exposure can be compared directly.

a. The SI unit for effective dose is joule per kilogram (J/kg), termed the sievert (Sv). An explanation of the quantity is given in annex B to [INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, The 2007 Recommendations of the International Commission on Radiological Protection, Publication 103, Ann. ICRP 37 2–4, Elsevier Science, Oxford (2007).].

Definition

The quantity H_T,R, defined as:
H_T,R = w_R . D_T,R
where D_T,R is the absorbed dose delivered by radiation type R averaged over a tissue or organ T and w_R is the radiation weighting factor for radiation type R. When the radiation field is composed of different radiation types with different values of w_R, the equivalent dose is:
H_T = S_Rw_R . D_T,R

Scope notes

a. The SI unit for equivalent dose is joule per kilogram (J/kg), termed the Sievert (Sv). An explanation of the quantity is given in annex B to [INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, The 2007 Recommendations of the International Commission on Radiological Protection, Publication 103, Ann. ICRP 37 2–4, Elsevier Science, Oxford (2007).].

b. The rem, equal to 0.01 Sv, is sometimes used as a unit of equivalent dose and effective dose. This should not be used in IAEA publications, except when quoting directly from other publications, in which case the value in sieverts should be added in parentheses.

c. Equivalent dose is a measure of the dose to a tissue or organ designed to reflect the amount of harm caused.

d. Equivalent dose cannot be used to quantify higher doses or to make decisions on the need for any medical treatment relating to deterministic effects.

e. Values of equivalent dose to a specified tissue or organ from any type(s) of radiation can be compared directly.

Definition

The process of manufacturing and assembling the components of a facility, the carrying out of civil works, the installation of components and equipment, and the performance of associated tests.

Scope notes

The terms siting, design, construction, commissioning, operation and decommissioning are normally used to delineate the six major stages of the lifetime of an authorized facility and of the associated licensing process. In the special case of disposal facilities for radioactive waste, decommissioning is replaced in this sequence by closure.

Definition

Events unconnected with the operation of a facility or the conduct of an activity that could have an effect on the safety of the facility or activity.

Scope notes

a. Typical examples of external events for nuclear facilities include earthquakes, tornadoes, tsunamis and aircraft crashes.

b. In the case of safety assessment for long term safety in waste management, a relevant external event is one that could have an effect on the functioning of multiple barriers.

Definition

Operation within specified operational limits and conditions.

Scope notes

For a nuclear power plant, this includes startup, power operation, shutting down, shutdown, maintenance, testing and refuelling.

Definition

A set of rules setting forth parameter limits, the functional capability and the performance levels of equipment and personnel approved by the regulatory body for safe operation of an authorized facility.

Definition

A general term encompassing all of the elements (items) of a facility or activity that contribute to protection and safety, except human factors.

Scope notes

Human factors may be reflected in structures, systems and components in so far as ergonomics — the study of people’s efficiency in their work setting — is an element in their design.

Definition

1. The function or power or (usually as controls) means of directing, regulating or restraining.

Scope notes

It should be noted that the usual meaning of the English word control in safety related contexts is somewhat ‘stronger’ (more active) than that of its usual translations and other similar words in some other languages. For example, control typically implies not only checking or monitoring something but also ensuring that corrective or enforcement measures are taken if the results of the checking or monitoring indicate such a need. This is in contrast, for example, to the more limited usage of the equivalent word in French and Spanish.

Definition

1. Methods or physical structures designed to prevent or control the release and the dispersion of radioactive substances.

Scope notes

Although related to confinement, containment is usually used to refer to methods or structures that perform a confinement function in facilities and activities, namely preventing or controlling the release of radioactive substances and their dispersion in the environment. See confinement for a more extensive discussion.

In the context of waste disposal, the containment of the radionuclides associated with the waste is through the provision of engineered barriers and natural barriers - including the waste form and packaging, backfill materials, the host environment and geological formations - for confinement of the radionuclides within the waste matrix, the packaging and the disposal facility and thus its isolation from the environment.

Definition

Item that is designed to perform a safety function for or that has a safety function for design extension conditions.

Scope notes

The concept of safety features for design extension conditions also applies for research reactors and nuclear fuel cycle facilities.

Definition

2. Continuous or periodic measurement of radiological or other parameters or determination of the status of a structure, system or component.

Scope notes

a. Sampling may be involved as a preliminary step to measurement.

b. Although the concept is not fundamentally different from definition (1), this definition is more suited to the types of monitoring concerned primarily with safety (i.e. keeping sources under control) rather than with protection (i.e. controlling exposure).

c. This definition is particularly relevant to monitoring the status of a nuclear installation by tracking plant variables, or monitoring the long term performance of a waste disposal facility by tracking variables such as water fluxes.

d. These examples differ from definition (1) in that the routine measurements are themselves of no particular interest; the monitoring is only intended to detect unexpected deviations if they occur.

Definition

2. Confirmation by examination and by means of objective evidence that specified objectives have been met and specified requirements for specific results have been fulfilled. See validation.

Scope notes

a. The corresponding status is termed ‘verified’.

b. Verification typically entails the assessment of the results of an individual activity against its inputs.

c. Verification may comprise activities such as: performing alternative calculations; comparing a new design specification with a similar proven design specification; undertaking tests and demonstrations; and reviewing documents prior to issue.

Definition

Provision of alternative (identical or diverse) structures, systems and components, so that any single structure, system or component can perform the required function regardless of the state of operation or failure of any other.

<h2>Definition</h2>1. A hierarchical deployment of different levels of diverse equipment and procedures to prevent the escalation of anticipated operational occurrences and to maintain the effectiveness of physical barriers placed between a radiation source or radioactive material and workers, members of the public or the environment, in operational states and, for some barriers, in accident conditions.<h2>Scope notes</h2><ul><li>a. The objectives of defence in depth are: <ul><li>(a) To compensate for human induced events and component failures; </li><li>(b) To maintain the effectiveness of the barriers by averting damage to the facility and to the barriers themselves; </li><li>(c) To protect workers, members of the public and the environment from harm in accident conditions in the event that these barriers are not fully effective</li></ul></li><li>c. Five levels of defence in depth are discussed in SSR-2/1 (Rev. 1) (See [INTERNATIONAL ATOMIC ENERGY AGENCY, Safety of Nuclear Power Plants: Design, IAEA Safety Standards Series No. SSR 2/1 (Rev. 1), IAEA, Vienna (2016).] for further information): <ul><li>(a) The purpose of the first level of defence is to prevent deviations from normal operation and the failure of items important to safety. </li><li>(b) The purpose of the second level of defence is to detect and control deviations from normal operation in order to prevent anticipated operational occurrences from escalating to accident conditions. </li><li>(c) The purpose of the third level of defence is to prevent damage to the reactor core and releases of radioactive material requiring off-site protective actions and to return the plant to a safe state by means of inherent and/or engineered safety features, safety systems and procedures. </li><li>(d) The purpose of the fourth level of defence is to prevent the progress of, and to mitigate the consequences of, accidents that result from failure of the third level of defence by preventing accident sequences that lead to large release of radioactive material or early release of radioactive material from occurring. </li><li>(e) The purpose of the fifth and final level of defence is to mitigate radiological consequences of a large release of radioactive material or an early release of radioactive material that could potentially result from an accident</li></ul></li><li>d. The International Nuclear Safety Group (INSAG) defined five levels of defence in depth (See [INTERNATIONAL NUCLEAR SAFETY ADVISORY GROUP, Defence in Depth in Nuclear Safety, INSAG Series No. 10, IAEA, Vienna (1996).] for further information): <ul><li>(a) Level 1: Prevention of abnormal operation and failures. </li><li>(b) Level 2: Control of abnormal operation and detection of failures. </li><li>(c) Level 3: Control of accidents within the design basis. </li><li>(d) Level 4: Control of severe plant conditions, including prevention of accident progression and mitigation of the consequences of severe accidents. </li><li>(e) Level 5: Mitigation of radiological consequences of significant releases of radioactive material.</li><li>e. The levels of defence are sometimes grouped into three safety layers: hardware, software and management control.</li><li>f. In the context of waste disposal, the term multiple barriers is used to describe a similar concept.</li><li>g. Note that defence in depth is used with a different meaning in the IAEA Nuclear Security Series in the context of nuclear security.</li><li>b. The Fundamental Safety Principles (IAEA Safety Fundamentals) [EUROPEAN ATOMIC ENERGY COMMUNITY, INTERNATIONAL ATOMIC ENERGY AGENCY, FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL LABOUR ORGANIZATION, INTERNATIONAL MARITIME ORGANIZATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, UNITED NATIONS ENVIRONMENT PROGRAMME, WORLD HEALTH ORGANIZATION, Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, IAEA, Vienna (2006).] (para. 3.31) states that: “Defence in depth is implemented primarily through the combination of a number of consecutive and independent levels of protection that would have to fail before harmful effects could be caused to people or to the environment. If one level of protection or barrier were to fail, the subsequent level or barrier would be available. When properly implemented, defence in depth ensures that no single technical, human or organizational failure could lead to harmful effects, and that the combinations of failures that could give rise to significant harmful effects are of very low probability. The independent effectiveness of the different levels of defence is a necessary element of defence in depth”.</li></ul>

Definition

The performance of actions to mitigate the consequences of an emergency for human life and health, property and the environment.

Scope notes

The emergency response also provides a basis for the resumption of normal social and economic activity.

Definition

Monitoring using measurements by equipment worn by individuals, or measurements of quantities of radioactive substances in or on or taken into the bodies of individuals, or measurements of quantities of radioactive substances excreted from the body by individuals.

Scope notes

Also called personal monitoring.

For workers, usually contrasted with workplace monitoring.

It includes, for example, measurements of quantities of radioactive substances taken into the body made using breathing zone air samplers.

Definition

A form of workplace monitoring in which an area is monitored by taking measurements at different points in that area.

Scope notes

As opposed to measurements by a static monitor.

Definition

The value of a quantity such as effective dose, intake or contamination per unit area or volume at or above which an investigation would be conducted.

Definition

The vessel into which the waste form is placed for handling, transport, storage and/or eventual disposal; also the outer barrier protecting the waste from external intrusions. The waste container is a component of the waste package. For example, molten high level waste glass would be poured into a specially designed container (canister), where it would cool and solidify.

Scope notes

Caution: Note that the term waste canister is considered to be a specific term for a container for spent fuel or vitrified high level waste.

Definition

The complete product of the packing operation, consisting of the packaging and its contents prepared for transport. The types of package covered by [the Transport] Regulations [INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018)] that are subject to the activitylimits and material restrictions of Section IV [of the Transport Regulations [INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018)]] and meet the corresponding requirements are:
(a) Excepted package;
(b) Industrial package Type 1 (Type IP-1);
(c) Industrial package Type 2 (Type IP-2);
(d) Industrial package Type 3 (Type IP-3);
(e) Type A package;
(f) Type B(U) package;
(g) Type B(M) package;
(h) Type C package. Packages containing fissile material or uranium hexafluoride are subject to additional requirements
(See INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018).)

Scope notes

The detailed specifications and requirements for these package types are specified in [INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2012 Edition, IAEA Safety Standards Series No. SSR-6, IAEA, Vienna (2012)].

Definition

An article of transport equipment that is of a permanent character and accordingly strong enough to be suitable for repeated use; specially designed to facilitate the transport of goods, by one or other modes of transport without intermediate reloading, designed to be secured and/or readily handled, having fittings for these purposes.

Scope notes

The freight container does not include the vehicle.

Definition

(a) For transport by road or rail: any vehicle;

(b) For transport by water: any vessel, or any hold, compartment, or defined deck area of a vessel;

(c) For transport by air: any aircraft

(See INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018).)

Definition

Radiological equipment used in medical radiation facilities to perform radiological procedures that either delivers an exposure to an individual or directly controls or influences the extent of such exposure. The term applies to radiation generators, such as X ray machines or medical linear accelerators; to devices containing sealed sources, such as ⁶⁰Co teletherapy units; to devices used in a medical imaging procedure involving ionizing radiation to capture images, such as gamma cameras, image intensifiers or flat panel detectors; and to hybrid systems such as positron emission tomography–computed tomography scanners.

Definition

An imaging device designed specifically for imaging persons or cargo conveyances for the purpose of detecting concealed objects on or within the human body or within cargo or a vehicle.

Scope notes

In some types of inspection imaging device, ionizing radiation is used to produce images by backscatter, transmission or both.

Other types of inspection imaging device utilize imaging by means of electrical and magnetic fields, ultrasound and sonar waves, nuclear magnetic resonance, microwaves, terahertz rays, millimetre waves, infrared radiation or visible light.

Definition

3. [For each Contracting Party any body or bodies given the legal authority by that Contracting Party to grant licences and to regulate the siting, design, construction, commissioning, operation or decommissioning of nuclear installations.] (See Convention on Nuclear Safety, INFCIRC/449, IAEA, Vienna (1994).)

Definition

States defined under normal operation and anticipated operational occurrences.

Scope notes

Some States and organizations use the term operating conditions (in contrast to accident conditions) for this concept.

Definition

Deviations from normal operation that are less frequent and more severe than anticipated operational occurrences.

Scope notes

Examples of such deviations include a major fuelfailure or a loss of coolant accident (LOCA).

See accident, event.

Accident conditions are considered in the design and comprise design basis accidents and design extension conditions.

Definition

1. The measurement of dose, dose rate or activity for reasons relating to the assessment or control of exposure to radiation or exposure due to radioactive substances, and the interpretation of the results.

Scope notes

a. ‘Measurement’ is used somewhat loosely. The ‘measurement’ of dose often means the measurement of a dose equivalent quantity as a proxy (i.e. substitute) for a dose quantity that cannot be measured directly. Also, sampling may be involved as a preliminary step to measurement.

d. Monitoring may be subdivided in two different ways: according to where the measurements are made, into individual monitoring, workplace monitoring, source monitoring and environmental monitoring; and, according to the purpose of the monitoring, into routine monitoring, task related monitoring and special monitoring.

b. Measurements may actually be of radiation levels, airborne activity concentrations, levels of contamination, quantities of radioactive material or individual doses.

c. The results of these measurements may be used to assess radiological hazards or doses resulting or potentially resulting from exposure.

Definition

Medical supervision intended to ensure the initial and continuing fitness of workers for their intended tasks.

Definition

A defined area in which specific protection measures and safety provisions are or could be required for controlling exposures or preventing the spread of contamination in normal working conditions, and preventing or limiting the extent of potential exposures.

Scope notes

A controlled area is often within a supervised area, but need not be.

The term [radiation area] is sometimes used to describe a similar concept, but controlled area is preferred in IAEA publications.

Definition

Systematic arrangements that are aimed at providing adequate consideration of radiation protection measures. (See INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018).)

Definition

This terms encompasses several sub-terms, such as [radiation area], controlled area, hazard control area, inner area, limited access area, operational control area, operations area, protected area, site area, site boundary, supervised area.

Definition

1. Radioactive substances on surfaces, or within solids, liquids or gases (including the human body), where their presence is unintended or undesirable, or the process giving rise to their presence in such places.

Scope notes

a. Also used less formally to refer to a quantity, namely the activity on a surface (or on a unit area of a surface).

c. Caution: The term contamination may have a connotation that is not intended. The term contamination refers only to the presence of radioactivity, and gives no indication of the magnitude of the hazard involved.

b. Contamination does not include residual material remaining at a site after the completion of decommissioning.

d. Caution:The term ‘contaminated evidence’ connotes a different meaning for the forensic scientist and for the nuclear forensic scientist. In general forensic science usage, ‘contaminated evidence’ refers to evidence contaminated with extraneous material, and thus compromised. Care should be taken to ensure that there is no possibility of confusion in referring to the presence of radionuclides on or within physical evidence: the term ‘evidence contaminated with radionuclides’ should be used to clarify this meaning.

Definition

A deviation of an operational process from normal operation that is expected to occur at least once during the operating lifetime of a facility but which, in view of appropriate design provisions, does not cause any significant damage to items important to safety or lead to accident conditions.

Scope notes

Examples of anticipated operational occurrences are loss of normal electrical power and faults such as a turbine trip, malfunction of individual items of a normally running plant, failure to function of individual items of control equipment, and loss of power to the main coolant pump.

Some States and organizations use the term abnormal operation (for contrast with normal operation) for this concept.

Definition

A physical obstruction that prevents or inhibits the movement of people, radionuclides or some other phenomenon (e.g. fire), or provides shielding against radiation.

Definition

Monitoring using measurements made in the working environment.

Scope notes

Usually contrasted with individual monitoring.

Definition

The complete or partial removal of contamination by a deliberate physical, chemical or biological process.

Scope notes

This definition is intended to include a wide range of processes for removing contamination from people, equipment and buildings, but to exclude the removal of radionuclides from within the human body or the removal of radionuclides by natural weathering or migration processes, which are not considered to be decontamination. See also remediation.

Definition

1. The dose per unit time.

Scope notes

Caution: Although dose rate could, in principle, be defined over any unit of time (e.g. an annual dose is technically a dose rate), in IAEA publications the term dose rate should be used only in the context of short periods of time, for example dose per second or dose per hour.

Definition

2. The activity of a radionuclide taken into the body in a given time period or as a result of a given event.

Definition

The quantity E(t), defined as:
E(t) = S_Tw_T . H_T(t)
where H_T(t) is the committed equivalent dose to tissue or organ T over the integration time t elapsed after an intake of radioactive substances and w_T is the tissue weighting factor for tissue or organ T. Where t is not specified, it will be taken to be 50 years for intakes by adults and the time to the age of 70 years for intakes by children.

Scope notes

That is, for intakes by children, 70 years minus the age in years: so, for example, 60 years for a 10 year old child.

Definition

A level of dose, exposure or intake specified by the regulatory body at or above which values of dose to, exposure of or intake by workers are to be entered in their individual exposure records.

Definition

In dosimetry, unless otherwise stated, an infant is assumed to be three months old, and annual quantities (e.g. annual dose, annual intake) relating to an infant refer to the year starting at birth.

Scope notes

c. See also child and reference individual.

a. The values for the three month old infant are intended to be valid for the first year of life.

b. In common usage for internal dosimetry an infant is taken to be 100 days old.

Definition

A limit on a measurable quantity, established or formally accepted by a regulatory body.

Scope notes

Caution: Wherever possible, authorized limit should be used in preference to prescribed limit.

Equivalent in meaning to prescribed limit, authorized limit has been more commonly used in radiation safety and the safety of radioactive waste management, in particular in the context of limits on discharges.

Definition

1. The process and the result of developing a concept, detailed plans, supporting calculations and specifications for a facility and its parts.

Scope notes

The terms siting, design, construction, commissioning, operation and decommissioning are normally used to delineate the six major stages of the lifetime of an authorized facility and of the associated licensing process. In the special case of disposal facilities for radioactive waste, decommissioning is replaced in this sequence by closure.

Definition

An engineered facility where waste is emplaced for disposal.

Scope notes

Synonymous with repository.

Definition

The spreading of radionuclides in air (aerodynamic dispersion) or water (hydrodynamic dispersion) resulting mainly from physical processes affecting the velocity of different molecules in the medium.

Scope notes

a. Often used in a more general sense combining all processes (including molecular diffusion) that result in the spreading of a plume. The terms atmospheric dispersion and hydrodynamic dispersion are used in this more general sense for plumes in air and water, respectively.

b. In usual language synonymous with dispersal, but dispersion is mostly used more specifically as defined above, whereas dispersal is typically (though not universally) used as a more general expression.

Definition

A route by which radiation or radionuclides can reach humans and cause exposure.

Scope notes

An exposure pathway may be very simple, for example the external exposurepathway from airborne radionuclides, or a more complex chain, for example the internal exposurepathway from drinking milk from cows that ate grass contaminated with deposited radionuclides.

Definition

An individual receiving a dose that is representative of the doses to the more highly exposed individuals in the population.

Scope notes

See also member of the public.

a. The representative person will generally be a hypothetical construct and not an actual member of the population. The concept is used to determine compliance or in prospective assessments.

b. In estimating the dose to the representative person, a number of factors are taken into account for the population exposed: (i) all relevant exposure pathways for the source and all locations under consideration; (ii) the spatial distribution of radionuclides in the environment, to ensure that individuals with higher exposures are included; (iii) age dependent physiological parameters and information on diet, habits, residence and use of local resources; (iv) dosimetric models and appropriate dose coefficients.

c. Application of the concept of a representative person to potential exposures, such as those that may occur in the future as a result of radioactive wastedisposal, is complicated by the facts that both the dose (if it occurs) and the probability of receiving the dose are relevant, and that these two parameters are essentially independent of one another.

d. Hence, a population can be homogeneous with respect to dose but not risk, and, more importantly, vice versa.

e. A possible approach is to define a representative person that is reasonably representative with respect to risk, and that is typical of those people who might be subject to the highest risk.

f. ICRP Publication 101 [INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Assessing Dose of the Representative Person for the Purpose of Radiation Protection of the Public and the Optimisation of Radiological Protection: Broadening the Process, ICRP Publication 101, Ann. ICRP 36 3, Elsevier Science, Oxford (2006).] indicates that the dose to the representative person “is the equivalent of, and replaces, the mean dose in the ‘critical group’”, and provides guidance on assessing doses to the representative person. The concept of critical group remains valid.

Definition

A set of instructions describing in detail the actions to be taken by emergency workers in an emergency.

Definition

The integrated set of infrastructural elements, put in place at the preparedness stage that are necessary to provide the capability for performing a specified function or task required in response to a nuclear or radiological emergency.

Scope notes

These elements may include: authorities and responsibilities, organization, coordination, personnel, plans, procedures, facilities, equipment or training.

Definition

Exposure to radiation from a source outside the body.

Scope notes

Contrasted with internal exposure.

Definition

Prevention or control of releases of radioactive material to the environment in operation or in accidents.

Scope notes

a. Confinement is closely related in meaning to containment, but confinement is typically used to refer to the safety function of preventing the ‘escape’ of radioactive material, whereas containment refers to the means for achieving that function.

b. Caution: The Transport Regulations adopt a different distinction between confinement and containment, namely that confinement relates to preventing criticality and containment to preventing releases of radioactive material (see confinement system and containment system).

c. The main issue here is the differences in usage between the safety of nuclear installations and safety in the transport of radioactive material. Both terms, containment and confinement, are used in both areas (in the Transport Regulations, in the form of confinement system and containment system), and the usages of containment are (it seems) conceptually consistent, but the usages of confinement are not. Confinement in nuclear safety is the safety function that is performed by the containment.

Definition

1. For a radionuclide, the time required for the activity to decrease, by a radioactive decay process, by half.

Scope notes

a. Where it is necessary to distinguish this from other half-lives (see (2)), the term radioactive half-life should be used.

b. The half-life is related to the decay constant, l, by the expression: T½ = ln2 / l

Definition

The holding of radioactive sources, radioactive material, spent fuel or radioactive waste in a facility that provides for their/its containment, with the intention of retrieval.

Scope notes

a. Generalized from the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management [Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management, INFCIRC/546, IAEA, Vienna (1997).], the Code of Conduct on the Safety and Security of Radioactive Sources [Code of Conduct on the Safety and Security of Radioactive Sources, IAEA, Vienna (2004).] and [INTERNATIONAL ATOMIC ENERGY AGENCY, Predisposal Management of Radioactive Waste, IAEA Safety Standards Series No. GSR Part 5, IAEA, Vienna (2009).].

b. Caution: Storage is by definition an interim measure, and the term interim storage would therefore be appropriate only to refer to short term temporary storage when contrasting this with the longer term fate of the waste.

c. Caution: Storage as defined above should not be described as interim storage.

d. Caution: In many cases, the only element of this definition that is important is the distinction between disposal (with no intent to retrieve) and storage (with intent to retrieve).

f. For storage in a combined storage and disposal facility, for which a decision may be made at the time of its closure whether to remove the waste stored during the operation of the storage facility or to dispose of it by encasing it in concrete, the question of intention of retrieval may be left open until the time of closure of the facility.

g. Contrasted with disposal.

e. In such cases, a definition is not necessary; the distinction can be made in the form of a footnote at the first use of the term disposal or storage (e.g. “Use of the term disposal indicates that there is no intention to retrieve the waste. If retrieval of the waste at any time in the future is intended, the term storage is used.”).

Definition

Any waste management steps carried out prior to disposal, such as pretreatment, treatment, conditioning, storage and transport activities.

Scope notes

Predisposal is not a form of disposal: predisposal is used as a contraction of ‘pre-disposal management of radioactive waste’.

Definition

The measurement of activity in radionuclides being released to the environment or of external dose rates due to sources within a facility or activity.

Scope notes

Contrasted with environmental monitoring.

Definition

The corresponding dose rate expressed in millisieverts per hour or microsieverts per hour. (See INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2012 Edition, IAEA Safety Standards Series No. SSR-6, IAEA, Vienna (2012).)

Scope notes

Caution: This usage was specific to previous edition of the Transport Regulations, and should be avoided.

Definition

The process of converting waste materials into new products.

Scope notes

a. Recycling reduces the wastage of useful materials, the use of raw materials and energy use.

b. Recycling contributes to reducing air pollution (caused by incineration) and reducing water pollution (caused by use of landfill sites) by reducing the need for disposal of conventional waste, and also contributes to reducing emissions of greenhouse gases.

Definition

A programme in which health tests or medical examinations are performed for the purpose of early detection of disease.

Definition

In dosimetry (e.g. in tables of dose per unit intake values), a child is often assumed to be a 10 year old. If such an assumption is made, it should be clearly stated.

Definition

A health professional, with specialist education and training in radiopharmacy, who is competent to prepare and dispense radiopharmaceuticals used for the purposes of medical diagnosis and radionuclide therapy.

Scope notes

Competence of persons is normally assessed by the State by having a formal mechanism for registration, accreditation or certification of radiopharmacists.

States that have yet to develop such a mechanism need to assess the education, training and competence of any individual proposed by the licensee to act as a radiopharmacist and to decide, on the basis of either international standards or standards of a State where such a system exists, whether such an individual could undertake the functions of a radiopharmacist.

Definition

A geometrical concept used in radiation therapy for planning medical treatment with consideration of the net effect of movements of the patient and of the tissues to be irradiated, variations in size and shape of the tissues, and variations in beam geometry such as beam size and beam direction.

Definition

A laboratory, designated by the relevant national authority, that possesses certification or accreditation necessary for the purpose of developing, maintaining or improving primary or secondary standards for radiation dosimetry.

Definition

The fundamental dosimetric quantity D, defined as:
D = d`e / dm
where d`e is the mean energy imparted by ionizing radiation to matter in a volume element and dm is the mass of matter in the volume element.

Scope notes

a. The energy can be averaged over any defined volume, the average dose being equal to the total energy imparted in the volume divided by the mass in the volume.

b. Absorbed dose is defined at a point; for the average dose in a tissue or organ, see organ dose.

c. The SI unit for absorbed dose is joule per kilogram (J/kg), termed the gray (Gy) (formerly, the rad was used).

Definition

Assessments such as audits or surveillance carried out to determine the extent to which the requirements for the management system are fulfilled, to evaluate the effectiveness of the management system and to identify opportunities for improvement. They can be conducted by or on behalf of the organization itself for internal purposes, by interested parties such as customers and regulators (or by other persons on their behalf), or by external independent organizations.

Scope notes

a. This definition applies in management systems and related fields.

b. Persons conducting independent assessments do not participate directly in the work being assessed.

c. Independent assessment activities include internal and external audit, surveillance, peer evaluation and technical review, which are focused on safety aspects and areas where problems have been found.

d. An audit is used in the sense of a documented activity performed to determine by investigation, examination and evaluation of objective evidence the adequacy of, and adherence to, established procedures, instructions, specifications, codes, standards, administrative or operational programmes and other applicable documents, and the effectiveness of their implementation.

Definition

Levels for the projected dose or the dose that has been received at which protective actions and other response actions are to be taken.

Scope notes

The term generic criteria as defined here relates to emergency preparedness and emergency response only.

Definition

The dose that would be expected to be received if planned protective actions were not taken.

Definition

Values of measurable quantities or observable conditions (i.e. observables) to be used in the response to a nuclear or radiological emergency in order to determine the need for appropriate protective actions and other response actions.

Scope notes

Operational criteria used in an emergency include operational intervention levels (OILs), emergency action levels (EALs), specific observable conditions (i.e. observables) and other indicators of conditions on the site.

Operational criteria are sometimes referred to as triggers.

Definition

The period of time from the detection of conditions warranting emergency response actions that must be taken promptly in order to be effective until the completion of all such actions.

Scope notes

Defined in IAEA Safety Glossary 2007 Edition.

Such emergency response actions include mitigatory actions by the operator and urgent protective actions on the site and off the site.

Definition

A set level of a measurable quantity that corresponds to a generic criterion.

Scope notes

b. An operational intervention level is used immediately and directly (without further assessment) to determine the appropriate protective actions on the basis of an environmental measurement.

a. Operational intervention levels are typically expressed in terms of dose rates or of activity of radioactive material released, time integrated air activity concentrations, ground or surface concentrations, or activity concentrations of radionuclides in environmental, food or water samples.

Definition

A specific, predetermined criterion for observable conditions used to detect, recognize and determine the emergency class.

Scope notes

An emergency action level could represent an instrument reading, the status of a piece of equipment or any observable event, such as a fire.

Definition

A deterministic effect that is fatal or life threatening or results in a permanent injury that reduces quality of life.

Definition

An organization designated or recognized by a State as being responsible for managing or implementing any aspect of an emergency response.

Scope notes

This also includes those organizations or services necessary to support the management and/or conduct of an emergency response, such as meteorological services.

Definition

The total radiation dose incurred by a population.

Scope notes

a. This is the sum of all of the individual doses to members of the population. If the doses continue for longer than a year, then the annual individual doses must also be integrated over time.

b. Unless otherwise specified, the time over which the dose is integrated is infinite; if a finite upper limit is applied to the time integration, the collective dose is described as ‘truncated’ at that time.

c. Although the upper limit for the integral for collective dose could in principle be infinite, in most assessments of collective dose the component part associated with individual doses or dose rates that are higher than the thresholds for the induction of deterministic effects would be considered separately.

d. Unless otherwise specified, the relevant dose is normally the effective dose (collective effective dose has a formal definition).

e. Unit: person-sievert (person Sv). This is, strictly, just a sievert, but the unit person-sievert is used to distinguish the collective dose from the individual dose which a dosimeter would measure (just as, for example, ‘person-hours’ are used to measure the total effort devoted to a task, as opposed to the elapsed time that would be shown by a clock).

f. Contrasting term: individual dose.

Definition

A typical fraction of the time for which a location is occupied by an individual or group.

Definition

3. A predetermined criterion defining the point at which a specific task or process will be considered completed.

Scope notes

b. In such a context, this criterion may also be an end point in the sense of definition (2), i.e. A radiological or other measure of protection or safety that is the calculated result of an analysis or assessment. — such criteria are often calculated on the basis of a level of dose or risk that is considered acceptable — but its application to the actual decontamination or remediation operations is in the sense of definition (3).

a. This usage often occurs in contexts such as decontamination or remediation, where the end point is typically the level of contamination beyond which further decontamination or remediation is considered unnecessary. One or more end point criteria are generally established for each remedial action or group of related remedial actions to verify their completion in accordance with the remediation plan.

Definition

The ratio of the equilibrium equivalent concentration of ²²²Rn to the actual ²²²Rn concentration.

Definition

A postulated or assumed set of conditions and/or events.

Scope notes

See event.

Most commonly used in analysis or assessment to represent possible future conditions and/or events to be modelled, such as possible accidents at a nuclear facility, or the possible future evolution of a disposal facility and its surroundings. A scenario may represent the conditions at a single point in time or a single event, or a time history of conditions and/or events (including processes)

Definition

An analytical or physical representation or quantification of a real system and the ways in which phenomena occur within that system, used to predict or assess the behaviour of the real system under specified (often hypothetical) conditions.

Definition

The dose equivalent that would be produced by the corresponding aligned and expanded field in the ICRU sphere at a depth d on the radius vector opposing the direction of the aligned field.

Scope notes

Parameter defined at a point in a radiation field. Used as a directly measurable proxy (i.e. substitute) for effective dose for use in monitoring of external exposure.

The recommended value of d for strongly penetrating radiation is 10 mm.

Definition

The dose equivalent that would be produced by the corresponding expanded field in the ICRU sphere at a depth d on a radius in a specified direction Ω.

Scope notes

Parameter defined at a point in a radiation field. Used as a directly measurable proxy (i.e. substitute) for equivalent dose in the skin in monitoring of external exposure.

The recommended value of d for weakly penetrating radiation is 0.07 mm.

Definition

Any package or packages, or load of radioactive material, presented by a consignor for transport. (From INTERNATIONAL ATOMIC ENERGY AGENCY, Regulations for the Safe Transport of Radioactive Material — 2018 Edition, IAEA Safety Standards Series No. SSR-6 (Rev. 1), IAEA, Vienna (2018).)

Definition

Discharge in accordance with an authorization.

Definition

A source that could, if not under control, give rise to exposure sufficient to cause severe deterministic effects. This categorization is used for determining the need for emergency arrangements and is not to be confused with categorizations of sources for other purposes.

Scope notes

The term dangerous source relates to dangerous quantities of radioactive material (D values) as recommended in [INTERNATIONAL ATOMIC ENERGY AGENCY, Dangerous Quantities of Radioactive Material (D-values), Emergency Preparedness and Response, EPR-DVALUES 2006, IAEA, Vienna (2006).].

<h2>Definition</h2>Multiplier of the equivalent dose to a tissue or organ used for purposes of radiation protection to account for the different sensitivities of different tissues or organs to the induction of stochastic effects of radiation [INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, The 2007 Recommendations of the International Commission on Radiological Protection, Publication 103, Ann. ICRP 37 2–4, Elsevier Science, Oxford (2007).]. Recommended tissue weighting factors for calculating effective dose are given in the following table: <img src="https://vocabulary.iaea.org/https://nucleus.iaea.org/sites/nss-oui/Figures/i_8b76b922-3a4b-4fe2-8144-40611006b66b.JPG" style="width: 480px;">

Definition

The lifetime dose expected to result from an intake. See dose quantities: committed equivalent dose and committed effective dose.

Scope notes

This term partially supersedes [dose commitment].

Definition

The dose equivalent in soft tissue below a specified point on the body at an appropriate depth d.

Scope notes

d. H_p(3) is used for monitoring exposure of the lens of the eye.

a. Parameter used as a directly measurable proxy (i.e. substitute) for equivalent dose in tissues or organs or (with d = 10 mm) for effective dose, in individual monitoring of external exposure.

b. The recommended values of d are 10 mm for strongly penetrating radiation and 0.07 mm for weakly penetrating radiation.

e. ‘Soft tissue’ is commonly interpreted as the ICRU sphere.

c. H_p(0.07) is used for monitoring for hands and feet for all radiation types.

f. Recommended by the International Commission on Radiation Units and Measurements [INTERNATIONAL COMMISSION ON RADIATION UNITS AND MEASUREMENTS, Quantities and Units in Radiation Protection Dosimetry, Rep. 51, ICRU, Bethesda, MD (1993).], [INTERNATIONAL COMMISSION ON RADIATION UNITS AND MEASUREMENTS, Fundamental Quantities and Units for Ionizing Radiation, Rep. 60, ICRU, Bethesda, MD (1998).] as a simplification of the two separate terms [individual dose equivalent, penetrating, H_p(d)], and [individual dose equivalent, superficial, H_s(d)], defined in [INTERNATIONAL COMMISSION ON RADIATION UNITS AND MEASUREMENTS, Determination of Dose Equivalents Resulting from External Radiation Sources, Rep. 39, ICRU, Bethesda, MD (1985).].

Definition

A measure of the density of particles in a radiation field, defined as:
F = dN / da
where dN is the number of particles incident on a sphere of cross-sectional area da.

Scope notes

The particle fluence rate
F / dt
is denoted by a lower case f. See [INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, Conversion Coefficients for Use in Radiological Protection against External Radiation, ICRP Publication 74, Annals of the ICRP Volume 26/3, Pergamon Press, Oxford and New York (1997).].

Definition

Used by the International Commission on Radiological Protection and others as a synonym for dose per unit intake, but sometimes also used to describe other coefficients linking quantities or concentrations of activity to doses or dose rates, such as the external dose rate at a specified distance above a surface with a deposit of a specified activity per unit area of a specified radionuclide.

Scope notes

Caution: To avoid confusion, the term dose coefficient should be used with care.

Definition

The SI unit of kerma and absorbed dose, equal to 1 J/kg.

Definition

An urgent protective action taken before or shortly after a release of radioactive material, or an exposure, on the basis of the prevailing conditions to avoid or to minimize severe deterministic effects.

Definition

Exposure to radiation from a source within the body.

Scope notes

Contrasted with external exposure.

Definition

An intake occurring within a time period short enough that it can be treated as instantaneous for the purposes of assessing the resulting committed dose.

Scope notes

Caution: The exposure that results from an acute intake is not necessarily acute exposure. For a long lived radionuclide that is retained in the body, an acute intake will result in chronic (i.e. long term) exposure.

<h2>Definition</h2>A measure of the relative effectiveness of different radiation types at inducing a specified health effect, expressed as the inverse ratio of the absorbed doses of two different radiation types that would produce the same degree of a defined biological end point.<h2>Scope notes</h2><ul><li>Values of relative biological effectiveness in causing the development of deterministic effects are selected to be representative of the severe deterministic effects that are significant to emergency preparedness and response. The tissue or organ specific and radiation type specific values of RBET,R for the development of selected severe deterministic effects are as shown in the table <img src="https://nucleus.iaea.org/sites/nss-oui/Figures/i_9c3078a2-6c03-4bf8-8dc6-b09d4b8f481d.JPG" style="width: 480px;"> </li></ul>

Definition

Radiation for which limits on effective dose are generally more restrictive than limits on equivalent dose to any tissue or organ; that is, the fraction of the relevant dose limit received will, for a given exposure, be higher for effective dose than for equivalent dose to any tissue or organ.

Scope notes

a. For most practical purposes, it may be assumed that strongly penetrating radiation includes photons of energy above about 12 keV, electrons of energy more than about 2 MeV, and neutrons.

b. Contrasting term: weakly penetrating radiation.

Definition

The quantity AD_T,R, defined as:
AD_T,R = D_T,R×RBE_T,R
where D_T,R is the absorbed dose delivered by radiation of type R averaged over a tissue or organ T and RBE_T,R is the relative biological effectiveness for radiation of type R in the production of severe deterministic effects in a tissue or organ T. When the radiation field is composed of different radiation types with different values of RBE_T,R the RBE weighted absorbed dose is given by:
AD_T = S_R D_T,R×RBE_T,R

Scope notes

a. The unit of RBE weighted absorbed dose is the gray (Gy), equal to 1 J/kg.

b. RBE weighted absorbed dose is a measure of the dose to a tissue or organ, intended to reflect the risk of development of severe deterministic effects.

c. Values of RBE weighted absorbed dose to a specified tissue or organ from any type(s) of radiation can be compared directly.

Definition

The action of the biological processes by means of which incorporated radionuclides are removed from the human body.

Scope notes

Decorporation may be promoted by chemical or biological agents.

Definition

The reverse is generally true. Radiation for which limits on equivalent dose to any tissue or organ are generally more restrictive than limits on effective dose; that is, the fraction of the relevant dose limit received will, for a given exposure, be higher for equivalent dose to any tissue or organ than for effective dose.

Scope notes

a. For most practical purposes, it may be assumed that weakly penetrating radiation includes photons of energy below about 12 keV, electrons of energy less than about 2 MeV, and massive charged particles such as protons and alpha particles.

b. Contrasting term: strongly penetrating radiation.

Definition

The administration of a compound of stable iodine (usually potassium iodide) to prevent or reduce the uptake of radioactive isotopes of iodine by the thyroid in a nuclear or radiological emergency, involving radioactive iodine.

Scope notes

Iodine thyroid blocking is an urgent protective action.

The term "stable iodine prophylaxis", ‘thyroid blocking’ or "iodine blockade" is sometimes used to describe the same concept, but iodine thyroid blocking is prefered in IAEA publications.

Definition

A protective action in the event of a nuclear or radiological emergency which must be taken promptly (usually within hours to a day) in order to be effective, and the effectiveness of which will be markedly reduced if it is delayed.

Scope notes

Urgent protective actions include iodine thyroid blocking, evacuation, short term sheltering, actions to reduce inadvertent ingestion, decontamination of individuals and prevention of ingestion of food, milk and drinking water possibly with contamination.

A precautionary urgent protective action is an urgent protective action taken before or shortly after a release of radioactive material, or an exposure, on the basis of the prevailing conditions to avoid or to minimize severe deterministic effects.

Definition

1. Exhibiting radioactivity; emitting or relating to the emission of ionizing radiation or particles. (adjective)

Scope notes

Caution: This is the ‘scientific’ definition, and should not be confused with the ‘regulatory’ definition (2).

Definition

The short term use of a structure for protection from an airborne plume and/or deposited radioactive material.

Scope notes

Sheltering is an urgent protective action, used to provide shielding against external exposure and to reduce the intake of airborne radionuclides by inhalation.

Definition

The rapid, temporary removal of people from an area to avoid or reduce short term radiation exposure in a nuclear or radiological emergency.

Scope notes

See also relocation.

Evacuation is an urgent protective action. It is expected to be in place for a short period of time (e.g. a day to a few weeks). If evacuation cannot be lifted within this short period of time, it should be substituted by relocation.

Evacuation may be taken as a performed as a precautionary urgent protective action based on observable conditions or plant conditions.

Definition

A protective action in the event of a nuclear or radiological emergency that can be implemented within days to weeks and can still be effective.

Scope notes

The most common early protective actions are relocation and longer term restriction of the consumption of food potentially affected by contamination.

Definition

The non-urgent removal or extended exclusion of people from an area to avoid long term exposure from deposited radioactive material.

Scope notes

Relocation is considered to be permanent relocation if return is not foreseeable; otherwise it is temporary relocation.

TABLE 1. ORGANIZATION OF THE REQUIREMENTS OF THESE STANDARDS
	Occupational exposure	Public exposure	Medical exposure
Planned exposure situations	Section 2; Section 3: paras 3.5–3.67 and paras 3.68–3.116	Section 2; Section 3: paras 3.5–3.67 and paras 3.117–3.144	Section 2; Section 3: paras 3.5–3.67 and paras 3.145–3.185
Emergency exposure situations	Section 2; Section 4	Section 2; Section 4	Not applicable
Existing exposure situations	Section 2; Section 5	Section 2; Section 5	Not applicable

Category	Ratio of activity in the source to activity that is considered dangerous^a (A/D)	Example of sources^b and practices
1		Radioisotope thermoelectric generators; Irradiators; Teletherapy sources; Fixed, multibeam teletherapy (‘gamma knife’) sources
2		Industrial gamma radiography sources; High/medium dose rate brachytherapy sources
3		Fixed industrial gauges incorporating high activitysources; Well logging gauges Low dose rate brachytherapy sources (except eye plaques and permanent implants);
4		Industrial gauges not incorporating high activity sources; Bone densitometers; Static eliminators
5	and level for exemption^c	Low dose rate brachytherapy eye plaques and permanent implant sources; X ray fluorescence devices; Electron capture devices; Mossbauer spectrometry sources; Positron emission tomography check sources

Radionuclide	D value (TBq)
Am-241	6 x 10^-2
Am-241/Be	6 x 10^-2
Au-198	2 x 10^-1
Cd-109	2 x 10¹
Cf-252	2 x 10^-2
Cm-244	5 x 10^-2
Co-57	7 x 10^-1
Co-60	3 x 10^-2
Cs-137	1 x 10^-1
Fe-55	8 x 10²
Gd-153	1 x 10⁰
Ge-68	7 x 10^-2
H-3	2 x 10³
I-125	2 x 10^-1
I-131	2 x 10^-1
Ir-192	8 x 10^-2
Kr-85	3 x 10¹
Mo-99	3 x 10^-1
Ni-63	3 x 10^-1
P-32	6 x 10¹
Pd-103	9 x 10¹
Pm-147	4 x 10¹
Po-210	6 x 10^-2
Pu-238	6 x 10^-2
Pu-239/Be	6 x 10^-2
Ra-226	4 x 10^-2
Ru-106 (Rh-106)	3 x 10^-1
Se-75	2 x 10^-1
Sr-90 (Y-90)	1 x 10⁰
Tc-99m	7 x 10^-1
Tl-204	2 x 10¹
Tm-170	2 x 10¹
Yb-169	3 x 10^-1

Acute external exposure (<10 h)
AD _{red marrow}^a	1 Gy	If the dose is projected: - Take precautionary urgent protective actions immediately (even under difficult conditions) to keep doses below the generic criteria - Provide public information and warnings - Carry out urgent decontamination
AD _fetus	0.1 Gy
AD _tissue^b	25 Gy at 0.5 cm
AD _skin^c	10 Gy to 100 cm²
Acute internal exposure due to an acute intake (Δ = 30 d)^d
AD(Δ)_{red marrow}	0.2 Gy for radionuclides with atomic number Z ≥ 90^e 2 Gy for radionuclides with atomic number Z ≤ 89^e	If the dose has been received: - Perform immediate medical examination, consultation and indicated medical treatment - Carry out contaminationcontrol - Carry out immediate decorporationf (if applicable) - Carry out registration for longer term medical follow-up - Provide comprehensive psychological counselling
AD(Δ)_thyroid	2 Gy
AD(Δ)_lung^g	30 Gy
AD(Δ)_colon	20 Gy
AD(Δ′)_fetus^h	0.1 Gy

Tasks	Guidance value^a
Life saving actions	Hp(10)^b < 500 mSv This value may be exceeded under circumstances in which the expected benefits to others clearly outweigh the emergency worker’s own health risks, and the emergency worker volunteers to take the action and understands and accepts these health risks
Actions to prevent severe deterministic effects and actions to prevent the development of catastrophic conditions that could significantly affect people and the environment	Hp(10) < 500 mSv
Actions to avert a large collective dose	Hp(10) < 100 mSv

Generic criteria		Examples of protective actions and other response actions
Projected dose that exceeds the following generic criteria : Take urgent protective actions and other response actions
H _thyroid	50 mSv in the first 7 days	Iodine thyroid blocking
E	100 mSv in the first 7 days	Sheltering; evacuation; decontamination; restrictions on food, milk and drinking water; contamination control; reassurance of the public
H _fetus	100 mSv in the first 7 days
Projected dose that exceeds the following generic criteria : Take early protective actions and other response actions
E	100 mSv in the first year	Temporary relocation; decontamination; restrictions on food, milk and drinking water; reassurance of the public
H _fetus	100 mSv for the full period of in utero development
Dose that has been received and that exceeds the following generic criteria : Take longer term medical actions to detect and to effectively treat radiation induced health effects
E	100 mSv in a month	Health screening based on equivalent doses to specific radiosensitive organs (as a basis for medical follow-up); counselling
H _fetus	100 mSv for the full period of in utero development	Counselling to allow informed decisions to be made in individual circumstances