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PLANNED EXPOSURE SITUATIONS

• SCOPE
  
  1. The requirements for planned exposure situations apply to the following practices:
     1. 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;
     2. The production and supply of devices that generate radiation, including linear accelerators, cyclotrons, and fixed and mobile radiography equipment;
     3. 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;
     4. 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;
     5. 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;
     6. The mining and processing of raw materials that involve exposure due to radioactive material;
     7. Any other practice as specified by the regulatory body.
  2. The requirements for planned exposure situations apply to exposure due to sources within practices16, as follows:
     1. Facilities that contain radioactive material and facilities that contain radiation generators, including nuclear installations, medical radiation facilities, veterinary radiation facilities, 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;
     2. 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.
  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.
  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:
     1. Exposure due to material{Footnote_17} 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;
     2. Public exposure due to discharges or due to the management of radioactive waste arising from a practice involving material as specified in (a) above;
     3. 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;
     4. 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
  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.
  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.
  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
  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 intention¹⁸. 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
  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 registration¹⁹ or licensing.
  9. Any person or organization applying for authorization:
     1. Shall submit to the regulatory body the relevant information necessary to support the application;
     2. Shall refrain from carrying out any of the actions specified in para. 3.5 until the registration or the licence has been issued;
     3. 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;
     4. 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;
     5. 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.
  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
  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.
  11. Exemption shall not be granted for practices deemed to be not justified.
  Clearance
  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.
  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.
  
  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.
  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.
  15. Registrants and licensees:
      1. 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;
      2. Shall ensure that any delegation of responsibilities by a principal party is documented;
      3. 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;
      4. 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;
      5. Shall assess the likelihood and magnitude of potential exposures, their likely consequences and the number of individuals who may be affected by them;
      6. Shall have in place operating procedures and arrangements for protection and safety that are subject to periodic review and updating under a management system;
      7. Shall establish procedures for reporting on and learning from accidents and other incidents;
      8. Shall establish arrangements for the periodic review of the overall effectiveness of the measures for protection and safety;
      9. Shall ensure that adequate maintenance, testing and servicing are carried out as necessary so that sources remain capable of fulfilling their design requirements for protection and safety throughout their lifetime;
      10. 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.
  
  16. The government or the regulatory body, as appropriate, shall ensure that provision²⁰ is made for the justification of any type of practice²¹ and for review of the justification, as necessary, and shall ensure that only justified practices are authorized.
  17. The following practices are deemed to be not justified:
      1. Practices, except for justified practices involving medical exposure²², that result in an increase in activity, by the deliberate addition of radioactive substances or by activation²³, in food, feed, beverages, cosmetics or any other commodity or product intended for ingestion, inhalation or percutaneous intake by, or application to, a person;
      2. 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;
      3. Human imaging using radiation that is performed as a form of art or for publicity purposes.
  18. Human imaging using radiation that is performed for occupational, legal or health insurance purposes²⁴, 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.
  19. Human imaging using radiation for theft detection purposes shall be deemed to be not justified.
  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.
  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.
  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.
  
  22. The government or the regulatory body:
      1. Shall establish and enforce requirements for the optimization of protection and safety;
      2. Shall require documentation addressing the optimization of protection and safety;
      3. Shall establish or approve constraints²⁵ 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.
  23. Registrants and licensees shall ensure that protection and safety is optimized.
  24. For occupational exposure and public exposure²⁶, 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:
      1. 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;
      2. 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.
  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
  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.
  
  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.
  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.
  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.²⁷
  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.
  
  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 assessment²⁸. 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.
  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.²⁹
  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:
      1. 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;
      2. 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;
      3. To assess the adequacy of the provisions for protection and safety.
  32. The safety assessment shall include, as appropriate, a systematic critical review of:
      1. The operational limits and conditions for the operation of the facility;
      2. 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;
      3. The ways in which external factors could affect protection and safety;
      4. The ways in which operating procedures relating to protection and safety might be erroneous, and the consequences of such errors;
      5. The implications for protection and safety of any modifications;
      6. The implications for protection and safety of security measures or of any modifications to security measures;
      7. Any uncertainties or assumptions and their implications for protection and safety.
  33. The registrant or licensee shall take into account in the safety assessment:
      1. 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;
      2. 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;
      3. 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;
      4. 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.
  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.
  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:
      1. Significant modifications to the facility or to its operating procedures or maintenance procedures are envisaged;
      2. Significant changes occur on the site that could affect the safety of the facility or of activities on the site;
      3. Information on operating experience, or information about accidents and other incidents that could result in exposures, indicates that the current assessment might be invalid;
      4. Any significant changes in activities are envisaged;
      5. Any relevant changes in guidelines or standards have been made or are envisaged.
  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.
  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.
  
  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.
  38. Registrants and licensees and employers shall ensure that:
      1. Monitoring and measurements of parameters are performed as necessary for verification of compliance with the requirements of these Standards;
      2. Suitable equipment is provided and procedures for verification are implemented;
      3. Equipment is properly maintained, tested and calibrated at appropriate intervals with reference to standards traceable to national or international standards;
      4. 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;
      5. The results of monitoring and verification of compliance are shared with the regulatory body as required.
  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
  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:
      1. Take account of international and national standards;
      2. Be supported by managerial and organizational features, with the purpose of ensuring protection and safety throughout the lifetime of the facility;
      3. 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;
      4. 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
  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:
      1. Preventing accidents;
      2. Mitigating the consequences of any accidents that do occur;
      3. Restoring the sources to safe conditions after any such accidents. Accident prevention
  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.
  42. The registrant or licensee for any facility or activity shall make suitable arrangements:
      1. To prevent reasonably foreseeable accidents in the facility or the activity;
      2. To mitigate the consequences of those accidents that do occur;
      3. To provide workers with the information, instruction, training and equipment necessary to restrict potential exposures;
      4. To ensure that there are adequate procedures for the control of the facility and for the management of any reasonably foreseeable accidents;
      5. 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;
      6. 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;
      7. 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;
      8. 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;
      9. To ensure that all relevant safety documentation is available in the appropriate languages understandable to users.
  Defence in depth
  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:
      1. Provision for individual monitoring and area monitoring, and arrangements for medical treatment;
      2. Arrangements for assessing and mitigating any consequences of an emergency.
  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:
      1. 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;
      2. Make available equipment, instrumentation and diagnostic aids that may be needed;
      3. Train and periodically retrain personnel in the procedures to be followed and exercise the procedures.
  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.
  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.
  46. Registrants and licensees shall conduct an investigation as specified by the regulatory body in the event that:
      1. A quantity or operating parameter relating to protection and safety exceeds an investigation level or is outside the stipulated range of operating conditions; or
      2. 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.
  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.
  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.
  Requirement 17: Radiation generators and radioactive sources
  Registrants and licensees shall ensure the safety of radiation generators and radioactive sources.
  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:
      1. 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:
         1. Provides for protection and safety in accordance with the requirements of these Standards;
         2. Meets engineering, performance and functional specifications;
         3. Meets quality standards commensurate with the significance for protection and safety of systems and components, including software;
         4. Provides clear displays, gauges and instructions on operating consoles in the appropriate language understandable to users.
      2. Ensuring that radiation generators and radioactive sources are tested to demonstrate compliance with the relevant specifications.
      3. 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.
      4. Ensuring that the protection provided by shielding and by other protective devices is optimized.
  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:
      1. Obtaining information on conditions of use and operating experience that may be important for protection and safety;
      2. 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.
  51. When choosing a location to use or to store a radiation generator or radioactive source, registrants and licensees shall take into account:
      1. Factors that could affect the safe management of and control over the radiation generator or radioactive source;
      2. Factors that could affect occupational exposure and public exposure due to the radiation generator or radioactive source;
      3. The feasibility of taking the foregoing factors into account in engineering design.
  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-site protective actions if they become necessary.
  53. Registrants and licensees shall maintain an inventory that includes records of:
      1. The location and description of each radiation generator or radioactive source for which they are responsible;
      2. The activity and form of each radioactive source for which they are responsible.
  54. Registrants and licensees shall provide the regulatory body as required with appropriate information from their inventory records of radiation generators and radioactive sources.
  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:
      1. Control over a radiation generator or radioactive source is relinquished only in compliance with all relevant requirements specified in the registration or licence;
      2. The regulatory body is promptly notified of information regarding a radiation generator or radioactive source that is lost, missing or not under control;
      3. A radiation generator or radioactive source is transferred only if the recipient possesses the necessary authorization;
      4. 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.
  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.
  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]³⁰.
  58. Registrants and licensees, in cooperation with manufacturers, shall ensure that, where practicable, sealed sources are identifiable and traceable.
  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.
  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.
  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.
  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:
      1. The benefits and detriments of implementing the type of human imaging procedure;
      2. The benefits and detriments of not implementing the type of human imaging procedure;
      3. Any legal or ethical issues associated with the introduction of the type of human imaging procedure;
      4. The effectiveness and suitability of the type of human imaging procedure, including the appropriateness of the radiation equipment for the intended use;
      5. The availability of sufficient resources to conduct the human imaging procedure safely throughout the intended period of the practice.
  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.
  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.
  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 insurance³¹ purposes without reference to clinical indications:
      1. 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;
      2. The registrant or licensee shall ensure that the appropriate optimization requirements 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.
  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.
  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.
  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.
• OCCUPATIONAL EXPOSURE
  Scope
  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), (c) 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.
  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.
  70. The government or the regulatory body shall establish and enforce requirements to ensure that protection and safety is optimized for occupational exposure.
  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.
  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:
      1. Design criteria and design features relating to the exposure and potential exposure of workers in all operational states and in accident conditions;
      2. 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.
  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.
  73. The regulatory body shall be responsible, as appropriate, for:
      1. 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;
      2. 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;
      3. Authorization or approval of service providers for individual monitoring and calibration services;
      4. Review of periodic reports on occupational exposure (including results of monitoring programmes and dose assessments) submitted by employers, registrants and licensees;
      5. Provision for maintaining exposure records and results of the assessment of doses from occupational exposure;
      6. Verification of compliance of an authorized practice with the requirements on the control of occupational exposure.
  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.
  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:
      1. Protection of workers against occupational exposure;
      2. Compliance with other relevant requirements of these Standards.
  75. Employers who are also registrants or licensees shall have the responsibilities of both employers and registrants or licensees.
  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:
      1. Occupational exposure is controlled so that the relevant dose limits for occupational exposure specified in Schedule III are not exceeded;
      2. Protection and safety is optimized in accordance with the requirements of these Standards;
      3. 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;
      4. 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 controlling occupational exposure;
      5. 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;
      6. Necessary workers’ health surveillance and health services for workers are provided;
      7. Appropriate monitoring equipment and personal protective equipment is provided and arrangements are made for its proper use, calibration, testing and maintenance;
      8. 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;
      9. Adequate records are maintained in accordance with the requirements of these Standards;
      10. 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;
      11. Necessary conditions for promoting safety culture are provided.
  77. Employers, registrants and licensees:
      1. Shall involve workers, through their representatives where appropriate, in optimization of protection and safety;
      2. Shall establish and use, as appropriate, constraints as part of optimization of protection and safety.
  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.
  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.
  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.
  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.
  82. Employers, registrants and licensees shall facilitate compliance by workers with the requirements of these Standards.
  Requirement 22: Compliance by workers
  Workers shall fulfil their obligations and carry out their duties for protection and safety.
  83. Workers:
      1. Shall follow any applicable rules and procedures for protection and safety as specified by the employer, registrant or licensee;
      2. Shall use properly the monitoring equipment and personal protective equipment provided;
      3. 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;
      4. 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;
      5. 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;
      6. 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.
  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.
  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.
  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.
  86. Cooperation between the employer and the registrant or licensee shall include, where appropriate:
      1. 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;
      2. Specific assessments of the doses received by workers as specified in (a) above;
      3. A clear allocation and documentation of the responsibilities of the employer and those of the registrant or licensee for protection and safety.
  87. As part of the cooperation between parties, the registrant or licensee responsible for the source or for the exposure as appropriate:
      1. 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;
      2. Shall provide appropriate information to the employer, including any available information relevant for compliance with the requirements of these Standards that the employer requests;
      3. Shall provide both the worker and the employer with the relevant exposure records.
  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
  88. Registrants and licensees shall designate as a controlled area any area³² in which specific measures for protection and safety are or could be required for:
      1. Controlling exposures or preventing the spread of contamination in normal operation;
      2. Preventing or limiting the likelihood and magnitude of exposures in anticipated operational occurrences and accident conditions.
  89. Cooperation between the employer and the registrant or licensee shall include, where appropriate:
      1. 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;
      2. Specific assessments of the doses received by workers as specified in (a) above;
      3. A clear allocation and documentation of the responsibilities of the employer and those of the registrant or licensee for protection and safety.
  90. As part of the cooperation between parties, the registrant or licensee responsible for the source or for the exposure as appropriate:
      1. 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;
      2. Shall provide appropriate information to the employer, including any available information relevant for compliance with the requirements of these Standards that the employer requests;
      3. Shall provide both the worker and the employer with the relevant exposure records.
  Classification of areas: Supervised areas
  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.
  92. Registrants and licensees, taking into account the nature, likelihood and magnitude of exposures or contamination in the supervised areas:
      1. Shall delineate the supervised areas by appropriate means;
      2. Shall display approved signs, as appropriate, at access points to supervised areas;
      3. 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.
  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:
      1. Engineered controls;
      2. Administrative controls;
      3. Personal protective equipment.
  Local rules and procedures and personal protective equipment
  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:
      1. Engineered controls;
      2. Administrative controls;
      3. Personal protective equipment.
  94. Registrants and licensees, taking into account the nature, likelihood and magnitude of exposures or contamination in the supervised areas:
      1. Shall delineate the supervised areas by appropriate means;
      2. Shall display approved signs, as appropriate, at access points to supervised areas;
      3. 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.
  95. 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:
      1. Engineered controls;
      2. Administrative controls;
      3. Personal protective equipment.
  96. Employers, registrants and licensees, in consultation with workers, or through their representatives where appropriate:
      1. Shall establish in writing local rules and procedures that are necessary for protection and safety for workers and other persons;
      2. 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;
      3. 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;
      4. 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;
      5. Shall designate, as appropriate, a radiation protection officer in accordance with criteria established by the regulatory body.
  97. Employers, registrants and licensees shall ensure that:
      1. Workers are provided with suitable and adequate personal protective equipment that meets relevant standards or specifications, including as appropriate:
         1. Protective clothing;
         2. Respiratory protective equipment the characteristics of which are made known to the users;
         3. Protective aprons, protective gloves and organ shields.
      2. Where appropriate, workers receive adequate instruction in the proper use of respiratory protective equipment, including testing for good fit.
      3. 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.
      4. All personal protective equipment, including equipment for use in an emergency, is maintained in proper condition and, if appropriate, is tested at regular intervals.
      5. 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
  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.
  97. The type and frequency of workplace monitoring:
      1. Shall be sufficient to enable:
         1. Evaluation of the radiological conditions in all workplaces;
         2. Assessment of exposures in controlled areas and supervised areas;
         3. Review of the classification of controlled areas and supervised areas.
      2. 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.
  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.
  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
  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.
  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 worker³³.
  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.
  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
  103. Employers, registrants and licensees shall maintain records of occupational exposure³⁴ for every worker for whom assessment of occupational exposure is required in paras 3.99–3.102.
  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.
  105. Records of occupational exposure shall include:
       1. Information on the general nature of the work in which the worker was subject to occupational exposure;
       2. 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;
       3. 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;
       4. 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.
  106. Employers, registrants and licensees:
       1. Shall provide workers with access to records of their own occupational exposure;
       2. 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;
       3. Shall facilitate the provision of copies of workers’ exposure records to new employers when workers change employment;
       4. Shall make arrangements for the retention of exposure records for former workers by the employer, registrant or licensee, as appropriate;
       5. Shall, in complying with (a)–(d) above, give due care and attention to maintaining the confidentiality of records.
  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
  108. Programmes for workers’ health surveillance as required in para. 3.76(f):
       1. Shall be based on the general principles of occupational health [19];
       2. Shall be designed to assess the initial fitness and continuing fitness of workers for their intended tasks.
  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.
  Requirement 26: Information, instruction and training
  Employers, registrants and licensees shall provide workers with adequate information, instruction and training for protection and safety.
  
  110. Employers, in cooperation with registrants and licensees:
       1. 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;
       2. 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;
       3. Shall maintain records of the training provided to individual workers.
  Requirement 27: Conditions of service
  Employers, registrants and licensees shall not offer benefits as substitutes for measures for protection and safety.
  
  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.
  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.
  
  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:
       1. The risk to the embryo or fetus due to exposure of a pregnant woman;
       2. The importance for a female worker of notifying her employer as soon as possible if she suspects that she is pregnant³⁵ or if she is breast-feeding;
       3. The risk of health effects for a breastfed infant due to ingestion of radioactive substances.
  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.
  115. Employers, registrants and licensees shall ensure that no person under the age of 16 years is or could be subject to occupational exposure.
  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 EXPOSURE
  Scope
  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
  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.
  
  118. The government or the regulatory body shall establish the responsibilities of registrants and licensees, of suppliers, and of providers of consumer products³⁶ in relation to the application of requirements for public exposure in planned exposure situations.
  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.
  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:
       1. The characteristics of the source and of the practice that are of relevance for public exposure;
       2. Good practice in the operation of similar sources;
       3. Dose contributions from other authorized practices or from possible future authorized practices³⁷, 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;
       4. The views of interested parties.
  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.
  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.
  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:
       1. Shall be used by registrants and licensees as the criteria for demonstration of compliance after the commencement of operation of a source;
       2. Shall correspond to doses below the dose limits with account taken of the results of optimization of protection and safety;
       3. Shall reflect good practice in the operation of similar facilities or activities;
       4. Shall allow for operational flexibility;
       5. 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)).
  124. When a source within a practice could cause public 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:
       1. 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;
       2. Shall, to the extent possible, establish requirements for the control of discharges;
       3. Shall arrange with the affected State the means for the exchange of information and consultations, as appropriate.
  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
  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.
  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 waste disposal facilities), shall take into account:
       1. 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;
       2. Good practice in the operation of similar sources or the conduct of similar practices;
       3. Possible buildup and accumulation in the environment of radioactive substances from discharges during the lifetime of the source;
       4. 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.
  127. Registrants and licensees, for sources under their responsibility, shall establish, implement and maintain:
       1. Policies, procedures and organizational arrangements for protection and safety in relation to public exposure, in accordance with the requirements of these Standards.
       2. Measures for ensuring:
          1. Optimization of protection and safety;
          2. Limitation of exposure of members of the public from such sources, in accordance with the authorization.
       3. Measures for ensuring the safety of such sources.
       4. 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.
       5. 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.
       6. Provision for appropriate monitoring equipment, monitoring programmes and methods for assessing public exposure.
       7. Adequate records of monitoring programmes.
       8. Emergency plans, emergency procedures and emergency arrangements, in accordance with the nature and magnitude of the radiation risks associated with the sources.
  Visitors
  128. Registrants and licensees, in cooperation with employers where appropriate:
       1. Shall apply the relevant requirements of these Standards in respect of public exposure for visitors to a controlled area or a supervised area;
       2. 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;
       3. 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;
       4. 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
  129. Registrants and licensees shall ensure that if a source can give rise to external exposure of members of the public:
       1. 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;
       2. 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.
  130. Registrants and licensees shall ensure, as appropriate, that:
       1. 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;
       2. 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.
  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
  131. Registrants and licensees, in cooperation with suppliers, as appropriate:
       1. Shall ensure that any radioactive waste generated is kept to the minimum practicable in terms of both activity and volume;
       2. 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;
       3. 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;
       4. 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 standards³⁸, and in accordance with the authorization;
       5. Shall maintain an inventory of all radioactive waste that is generated, stored, transferred or disposed of;
       6. Shall develop and implement a strategy for radioactive waste management and shall include appropriate evidence that protection and safety is optimized.
  Discharges
  132. Registrants and licensees, in cooperation with suppliers, in applying for an authorization for discharges, as appropriate:
       1. Shall determine the characteristics and activity of the material to be discharged, and the possible points and methods of discharge;
       2. 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;
       3. Shall assess the doses to the representative person due to the planned discharges;
       4. 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;
       5. 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.
  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.
  134. Registrants and licensees shall review and modify their discharge control measures, as appropriate and in agreement with the regulatory body, taking into account:
       1. Operating experience;
       2. Any changes in exposure pathways or in the characteristics of the representative person that could affect the assessment of doses due to the discharges.
  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.
  135. The regulatory body shall be responsible, as appropriate, for:
       1. Review and approval of monitoring programmes of registrants and licensees, which shall be sufficient for:
          1. Verifying compliance with the requirements of these Standards in respect of public exposure in planned exposure situations;
          2. Assessing doses from public exposure.
       2. Review of periodic reports on public exposure (including results of monitoring programmes and dose assessments) submitted by registrants and licensees.
       3. Making provision for an independent monitoring programme.
       4. 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.
       5. Making provision for maintaining records of discharges, results of monitoring programmes and results of assessments of public exposure.
       6. Verification of compliance of an authorized practice with the requirements of these Standards for the control of public exposure.
  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.
  137. Registrants and licensees shall, as appropriate:
       1. 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:
          1. External exposure due to such sources;
          2. Discharges;
          3. Radioactivity in the environment;
          4. Other parameters important for the assessment of public exposure.
       2. Maintain appropriate records of the results of the monitoring programmes and estimated doses to members of the public.
       3. 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.
       4. 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.
       5. 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.
       6. 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.
       7. Verify the adequacy of the assumptions made for the assessment of public exposure and the assessment for radiological environmental impacts.
       8. Publish or make available on request, as appropriate, results from source monitoring and environmental monitoring programmes and assessments of doses from public exposure.
  Requirement 33: Consumer products
  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.
  139. Upon receipt of a request for authorization to provide consumer products to the public, the regulatory body:
       1. Shall require the provider of the consumer product to provide documents to demonstrate compliance with the requirements in paras 3.138–3.144;
       2. Shall verify the assessments and the selection of parameters presented in the request for authorization;
       3. Shall determine whether the end use of the consumer product can be exempted;
       4. Shall authorize the provision to the public of the consumer product, where appropriate, subject to specific conditions of authorization.
  140. Providers of consumer products:
       1. Shall comply with the conditions of the authorization to provide consumer products to the public;
       2. Shall ensure that consumer products comply with the requirements of these Standards;
       3. Shall plan for appropriate arrangements for the servicing, maintenance, recycling or disposal of consumer products.
  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:
       1. The various radionuclides that could be used in consumer products and their radiation types, energies, activities and half-lives;
       2. 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;
       3. The containment and shielding of radioactive substances in consumer products and access to these radioactive substances in normal conditions and abnormal conditions;
       4. The need for servicing or repair of consumer products and ways in which this could be done;
       5. Relevant experience with similar consumer products.
  142. Providers of consumer products shall ensure that:
       1. Where practicable, a legible label is firmly affixed to a visible surface of each consumer product that:
          1. States that the consumer product contains radioactive substances and identifies the radionuclides and their activities;
          2. States that the provision of the consumer product to the public has been authorized by the regulatory body;
          3. Provides information on required or recommended options for recycling or disposal.
       2. The information specified in (a) above is also printed legibly on the retail packaging of the consumer product.
  143. Providers of consumer products shall provide clear and appropriate information and instructions with each consumer product on:
       1. Correct installation, use and maintenance of the consumer product;
       2. Servicing and repair;
       3. The radionuclides and their activities at a specified date;
       4. Dose rates in normal operation and during servicing and repair;
       5. Required or recommended options for recycling or disposal.
  144. Providers of consumer products shall provide the consumer product retailers with appropriate information on safety and instructions on their transport and storage.
• MEDICAL EXPOSURE
  Scope
  145. The requirements in respect of medical exposure in planned exposure situations (paras 3.146–3.185) apply to all medical exposures³⁹, including intended, unintended and accidental exposures.
  146. Dose limits do not apply to medical exposures.
  Requirement 34: Responsibilities of the government specific to medical exposure
  145. The requirements in respect of medical exposure in planned exposure situations (paras 3.146–3.185) apply to all medical exposures³⁹, including intended, unintended and accidental exposures.
  146. Dose limits do not apply to medical exposures.
  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.
  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.
  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:
       1. Dose constraints, to enable the requirements of paras 3.173 and 3.174, respectively, to be fulfilled for:
          1. Exposures of carers and comforters⁴⁰;
          2. Exposures due to diagnostic investigations of volunteers participating in a programme of biomedical research.
       2. 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.
  Requirement 35: Responsibilities of the regulatory body specific to medical exposure
  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:
       1. Are specialized⁴¹ in the appropriate area⁴²;
       2. Meet the respective requirements for education, training and competence in radiation protection, in accordance with para. 2.32;
       3. Are named in a list maintained up to date by the registrant or licensee.
  Requirement 36: Responsibilities of registrants and licensees specific to medical exposure
  151. Registrants and licensees shall ensure that no patient, whether symptomatic or asymptomatic, undergoes a medical exposure unless:
       1. 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;
       2. 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;
       3. 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);
       4. 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.
  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.
  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.
  154. Registrants and licensees shall ensure that:
       1. 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;
       2. 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;
       3. Sufficient medical personnel and paramedical personnel are available as specified by the health authority;
       4. 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;
       5. 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;
       6. Any delegation of responsibilities by a principal party is documented.
  Requirement 37: Justification of medical exposures
  155. Medical exposures shall be justified by weighing the diagnostic or therapeutic benefits⁴³ 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.
  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.
  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:
       1. The appropriateness of the request;
       2. The urgency of the radiological procedure;
       3. The characteristics of the medical exposure;
       4. The characteristics of the individual patient;
       5. Relevant information from the patient’s previous radiological procedures.
  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.
  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.
  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.
  161. The medical exposure of volunteers as part of a programme of biomedical research is deemed to be not justified unless:
       1. 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];
       2. 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.
  Requirement 38: Optimization of protection and safety
  Design considerations
  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
  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:
       1. Appropriate medical radiological equipment and software, and, for nuclear medicine, appropriate radiopharmaceuticals;
       2. 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.
  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.
  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.
  166. Registrants and licensees shall ensure that the particular aspects of medical exposures are considered in the optimization process for:
       1. Paediatric patients subject to medical exposure;
       2. Individuals subject to medical exposure as part of an approved health screening programme;
       3. Volunteers subject to medical exposure as part of a programme of biomedical research;
       4. Relatively high doses⁴⁴ to the patient;
       5. 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;
       6. Exposure of a breastfed infant as a result of a female patient having undergone a radiological procedure with radiopharmaceuticals.
  Calibration
  167. In accordance with para. 3.154(d) and (e), the medical physicist shall ensure that:
       1. All sources giving rise to medical exposure are calibrated in terms of appropriate quantities using internationally accepted or nationally accepted protocols;
       2. Calibrations are carried out at the time of commissioning a unit prior to clinical use, after any maintenance procedure that could affect the dosimetry and at intervals approved by the regulatory body;
       3. Calibrations of radiation therapy units are subject to independent verification⁴⁵ prior to clinical use;
       4. 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
  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:
       1. For diagnostic radiological procedures, typical doses to patients for common procedures;
       2. For image guided interventional procedures, typical doses to patients;
       3. 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;
       4. For therapeutic radiological procedures with unsealed sources, typical absorbed doses to patients.
  Diagnostic reference levels
  169. Registrants and licensees shall ensure that:
       1. 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).
       2. 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:
          1. Typical doses or activities exceed the relevant diagnostic reference level; or
          2. 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
  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.
  171. Registrants and licensees shall ensure that programmes of quality assurance for medical exposure include, as appropriate to the medical radiation facility:
       1. Measurements of the physical parameters of medical radiological equipment made by, or under the supervision of, a medical physicist:
          1. At the time of acceptance and commissioning of the equipment prior to its clinical use on patients;
          2. Periodically thereafter;
          3. After any major maintenance procedure that could affect protection and safety of patients;
          4. After any installation of new software or modification of existing software that could affect protection and safety of patients.
       2. Implementation of corrective actions if measured values of the physical parameters mentioned in (a) above are outside established tolerance limits.
       3. Verification of the appropriate physical and clinical factors used in radiological procedures.
       4. Maintaining records of relevant procedures and results.
       5. Periodic checks of the calibration and conditions of operation of dosimetry equipment and monitoring equipment.
  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
  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.
  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.
  Requirement 39: Pregnant or breast-feeding female patients
  Registrants and licensees and radiological medical practitioners shall ensure that protection and safety is optimized for each medical exposure.
  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 appropriate⁴⁶, 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:
       1. She is or might be pregnant;
       2. She is breast-feeding and the scheduled radiological procedure includes the administration of a radiopharmaceutical.
  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).
  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).
  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.
  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:
       1. 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
       2. The patient or the legal guardian of the patient is provided with:
          1. Written instructions for keeping doses to persons in contact with or in the vicinity of the patient as low as reasonably achievable and for avoiding the spread of contamination;
          2. Information on the radiation risks.
  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.
  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
  180. Registrants and licensees shall promptly investigate any of the following unintended or accidental medical exposures:
       1. 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;
       2. 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;
       3. Any exposure for diagnostic purposes that is substantially greater than was intended;
       4. Any exposure arising from an image guided interventional procedure that is substantially greater than was intended;
       5. Any inadvertent exposure of the embryo or fetus in the course of performing a radiological procedure;
       6. 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.
  181. Registrants and licensees shall, with regard to any unintended or accidental medical exposures investigated as required in para. 3.180:
       1. Calculate or estimate the doses received and the dose distribution within the patient;
       2. Indicate the corrective actions required to prevent the recurrence of such an unintended or accidental medical exposure;
       3. Implement all the corrective actions that are under their own responsibility;
       4. 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;
       5. 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.
  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
  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
  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:
       1. Records of any delegation of responsibilities by a principal party (as required in para. 3.154(f));
       2. Records of training of personnel in radiation protection (as required in para. 3.150(b)).
  184. 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.
  185. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following personnel records:
       1. Records of any delegation of responsibilities by a principal party (as required in para. 3.154(f));
       2. Records of training of personnel in radiation protection (as required in para. 3.150(b)).
  186. 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:
       1. Records of the results of the calibrations and periodic checks of the relevant physical and clinical parameters selected during treatment of patients;
       2. Records of dosimetry of patients, as required in para. 3.168;
       3. Records of local assessments and reviews made with regard to diagnostic reference levels, as required in para. 3.169;
       4. Records associated with the quality assurance programme, as required in para. 3.171(d).
  187. 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:
       1. For diagnostic radiology, information necessary for retrospective assessment of doses, including the number of exposures and the duration of fluoroscopic radiological procedures;
       2. 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;
       3. For nuclear medicine, the types of radiopharmaceutical administered and their activity;
       4. 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;
       5. Exposure records for volunteers subject to medical exposure as part of a programme of biomedical research;
       6. Reports on investigations of unintended and accidental medical exposures (as required in para. 3.181(d)).