1FOOD 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 , IAEA Safety Series No. 115, IAEA, Vienna (1996).

2The term ‘radiation’ in the context of these Standards means ionizing radiation.

3Obligations expressed as ‘must’ statements in Section 1 are quoted from the Fundamental Safety Principles [1].

4FOOD 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 , IAEA Safety Series No. 115, IAEA, Vienna (1996).

5The term ‘radiation risks’ is used in a general sense to refer to:— Detrimental health effects of radiation exposure (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.

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: 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. 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 management activities such as the discharge of effluents; and some aspects of the remediation of sites affected by residues from past activities.

7According to UNSCEAR [4], the worldwide average annual radiation dose from exposure due to naturally occurring , 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.

8It is generally accepted, for example, that it is not feasible to control ⁴⁰K in the body or cosmic radiation at the surface of the Earth.

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.

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’.

11Requirements on the governmental, legal and regulatory framework for safety of facilities and activities are established in Ref. [8].

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.

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.

14The regulatory body specifies which sources are to be included in the registers and inventories, with due consideration given to the associated risks.

15Requirements on the management system for facilities and activities are established in Ref. [13].

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.

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.

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.

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.

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.

21This provision for the justification of any type of practice includes practices for which notification alone is sufficient.

22Particular requirements for the justification of medical exposure are specified in paras 3.155–3.161.

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.

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.

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.

26Requirements for the optimization of medical exposure are specified in paras 3.162–3.177.

27Dose limits do not apply to medical exposures.

28Requirements on safety assessment for facilities and activities are established in Ref. [14].

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.

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 transport packages, freight containers or conveyances or on building access doors.

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.

32The transport of radioactive material is regulated in accordance with the IAEA Transport Regulations [12].

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].

34Records of occupational exposure are also referred to as ‘exposure records’ or ‘dose records’.

35Notification 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.

36The term ‘providers of consumer products’ includes the designers, manufacturers, producers, constructors, installers, distributors, sellers, and importers and exporters of consumer products.

37Dose contributions from possible future authorized practices have to be anticipated in an assessment made on the basis of realistic assumptions.

38Requirements 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].

39Requirements 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.

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‘Specialized’ means specialized as acknowledged by the relevant professional body, health authority or appropriate organization.

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.

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.

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‘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‘Other means of communication’ include explicitly asking female patients whether they are or might be pregnant or whether they are breast-feeding.

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.

48The voluntary basis for actions to be taken by emergency workers is usually covered in emergency arrangements.

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.

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.

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

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.

53Buildings with high occupancy factors for members of the public include kindergartens, schools and hospitals.

54Guidance on the preparation of an action plan for radon is provided in Ref. [6], for example.

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.

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.

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.

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.

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.

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.

61For the purposes of material in transport, ‘exemption’ means exemption from the requirements of the IAEA Transport Regulations [12].

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.

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.

64Regulatory control of construction materials incorporating radionuclides is addressed in Section 5 as an existing exposure situation.

65For example, specific clearance levels may be developed for metals, for rubble from buildings and waste for disposal in landfill sites.

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.

67The equivalent dose limits 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.

68For example, in authorized, justified and planned operational conditions that lead to transitory increases in exposures.

69Hp(10) is the personal dose equivalent Hp(d) where d = 10 mm.