Radiation Protection Dosimetry Advance Access published March 16, 2015 Radiation Protection Dosimetry (2015), pp. 1–4
doi:10.1093/rpd/ncv030
BASIS FOR STANDARDS: ICRP ACTIVITIES E. Vano* Radiology Department, Medicine Faculty, Complutense University and IdISSC San Carlos Hospital, Madrid 28040, Spain *Corresponding author: [email protected]
The purpose of this chapter is to describe work achieved recently by the International Commission on Radiological Protection (ICRP) and especially by Committee 3 (Protection in Medicine) and its use for standards. In March 1960, the Board of Governors of the International Atomic Energy Agency approved the Agency’s ‘Health and Safety Measures’, stating that the Agency’s ‘Basic Safety Standards’ (BSS) would be based, to the extent possible, on the recommendations of the ICRP. In a similar way, the Council of the European Union took into account the new recommendations of the ICRP when adopting the new Directive 2013/59/EURATOM that laid down BSS for protection against the dangers arising from exposure to ionising radiation. The new limit for the lens of the eyes for occupational exposures has been incorporated into these international standards and several articles dealing with medical exposures: justification, optimisation, recording patient doses, the use of diagnostic reference levels, training, accidental and unintended exposures, etc. have also been included in agreement with the ICRP recommendations.
INTRODUCTION In preparing its recommendations, the International Commission on Radiological Protection (ICRP) takes into account advances in scientific knowledge, evolving social values and practical experience, but the responsibility of formulating standards, regulations and codes of practice lies with other national and international organisations. ICRP consists of a Main Commission (MC), a Scientific Secretariat, and the five following standing Committees: Radiation Effects, Doses from Radiation Exposure, Protection in Medicine, Application of ICRP Recommendations and Protection of the Environment and Task Groups established when needed to undertake specific work (Figure 1). The Committees suggest priorities to produce recommendations on specific topics that the MC finally approves. Once a new draft document is produced, both the approvals of the Committee involved and the MC are required, before a 2–3-month public consultation. Once all the comments received have been considered and the draft has been improved, the document needs final approval from the Committee and the MC before adoption and publication. The Board of Governors of the International Atomic Energy Agency (IAEA) approved the Agency’s ‘Health and Safety Measures’ on March 1960 stating that the Agency’s ‘Basic Safety Standards’ (BSS) would be based, to the extent possible, on the recommendations of the ICRP. In a similar way, the Council of the European Union has taken into account the new recommendations of the ICRP, in particular those included in ICRP Publication
103 to adopt the new Directive 2013/59/EURATOM that laid down BSS for protection against the dangers arising from exposure to ionising radiation. The International BSS and the European BSS have incorporated the new limit of the lens of the eyes for occupational exposures and included several articles dealing with justification, optimisation, recording and reporting patient doses, the use of diagnostic reference levels (DRLs), training, accidental and unintended exposures, etc. in agreement with the ICRP recommendations. The purpose of this chapter is to describe work recently achieved by the ICRP and especially by Committee 3 (Protection in Medicine) and its use for standards, particularly European BSS.
ICRP Committee 3 Protection in Medicine Committee 3 of the ICRP is concerned with protection of persons and unborn children when ionising radiation is used for medical diagnosis, therapy or biomedical research. According to the 2011– 2017 Strategic Plan, Committee 3 develops recommendations and guidance for protection of patients, staff and the public against radiation exposure in medicine. International organisations and stakeholders are encouraged to propose topics of interest for new publications. In addition, a new mechanism, introduced at the 2013 ICRP Symposium, provides opportunities for symposium participants to provide input on suggested topics to the Commission’s committees. Since 2000, Committee 3 has produced, either alone or in conjunction with other ICRP committees,
# The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected]
E. VANO
Figure 1. ICRP structure and Committee 3 mandate.
18 reports dealing with radiological protection (RP) in medicine (abstracts are available at http://www. icrp.org/publications.asp). The reports cover topics on † † † † † †
Education and training in RP; Preventing accidental exposures in radiation therapy; Doses to patients from radiopharmaceuticals; Radiation safety aspects of brachytherapy; Release of patients after therapy with unsealed radionuclides; Managing radiation dose in interventional radiology, digital radiology, computed tomography, paediatrics, cardiology and other medical specialties.
Figure 2 shows the most recent documents published by Committee 3: Publication 117 on Radiological Protection in Fluoroscopically Guided Procedures performed outside the Imaging Department and Publication 120 on Radiological Protection in Cardiology and Publication 121 on Radiological Protection in Paediatric Diagnostic and Interventional Radiology. Publication 113 on Education and Training in Radiological Protection for Diagnostic and Interventional Procedures is also relevant for the potential impact on regulations and guidelines. These documents contain recommendations on patient and staff protection and the relationship between patient and staff. They also address aspects of occupational exposure during pregnancy.
ICRP STATEMENT ON TISSUE REACTIONS Since the statement of the ICRP on tissue reactions (deterministic effects) issued in April 2011(1), several regulatory initiatives and scientific activities have been launched to improve patient and staff radiation safety and to foster optimisation actions especially in fluoroscopy-guided procedures. The ICRP alerted the radiological community to the epidemiological evidence and pointed out some tissue reaction effects when threshold doses are or might be lower than previously considered: 0.5 Gy for the lens of the eye (radiation-induced opacities) and 0.5 Gy for circulatory disease of the heart or brain. Exposure of staff (lens of the eye) and of patients to doses of this magnitude could be reached during complex interventional procedures, and the ICRP recommended particular emphasis be placed on dose optimisation in these circumstances(2). For occupational exposure, the ICRP recommended an equivalent dose limit for the lens of the eye of 20 mSv y – 1, averaged over defined periods of 5 y, with the dose in a single year not exceeding 50 mSv. The immediate consequence was a change in the International BSS(3) and in the European BSS and the adoption of the new limit (4). EXAMPLES OF THE IMPACT OF SOME ICRP RECOMMENDATIONS ON REGULATIONS Some examples of ICRP recommendations now included in the European BSS, in addition to the new
Page 2 of 4
BASIS FOR STANDARDS
Figure 2. The most recent publications of ICRP (Committee 3).
occupational dose limit for the lens of the eyes, could be the following: †
Consideration of occupational and public exposures as part of the justification in medical exposures.
ICRP Publication 103(5) ( paragraph 209) states: ‘The medical use of radiation should be justified, as is any other planned exposure situation, although that justification lies more often with the profession than with government or the competent regulatory authority. The principal aim of medical exposures is to do more good than harm to the patient, due account being taken of the radiation detriment from the exposure of the radiological staff and of other individuals.’ And also in paragraph 330 of the same publication(5) it is said, ‘The principal aim of medical exposures is to do more good than harm to the patient, subsidiary account being taken of the radiation detriment from the exposure of the radiological staff and of other individuals.’ The new European directive on BSS(4) has considered this recommendation in Art. 19(4): ‘Practices involving medical exposure shall be justified both as a class or type of practice, taking into account medical and, where relevant, associated occupational and public exposures.’
patient, the staff, and sometimes the public. However, the choice also alters the scale of resources applied to protection. These resources may be reflected directly in financial costs, but they may also involve less easily quantified societal costs such as other health risks to staff.’ The new European directive on BSS(4) has also considered this recommendation in Art. 32(4): ‘Member States shall ensure that the operational protection of exposed workers is based, in accordance with the relevant provisions of this Directive, on . . . Optimization of radiation protection in all working conditions, including occupational exposures as a consequence of practices involving medical exposures.’ In comparison to the previous Medical Exposures Directive(7) (97/43/Euratom), many other changes introduced in the European BSS(4) (Directive 2013/ 59/Euratom) refer to the following:
Consideration of occupational exposures as part of the optimisation in medical exposures.
† Use of DRLs (including interventional) and their regular review, † Training aspects and the role of Medical Physics Experts in imaging, † Dosimetric information in all diagnostic systems and transfer to the patient report, † Dosimetric information mandatory for all interventional and CT procedures, † Registry and analysis of all the accidental or unintended irradiation of patients.
ICRP Publication 105(6) ( paragraph 69) states: ‘Optimization (medical). The choice of protection option directly alters the level of exposure of the
Some of these changes are in relation to several recommendations included by ICRP in its publications issued in recent years(8 – 14).
†
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E. VANO
The ICRP Publication 120 on Radiological Protection in Cardiology(13) included several recommendations considered, in part, by the new European Directive:
ICRP is open to considering new topics suggested during scientific congresses and workshops or by medical and other scientific societies.
†
REFERENCES
† † †
†
† †
Radiation dose data should be recorded in the patient’s medical record after the procedure. Patient dose reports should be archived for quality assurance purposes. Training programmes in RP should include both initial training for all incoming staff, and regular updating and retraining. A cardiologist should have management responsibility for the quality assurance programme aspects of RP for cardiology procedures and should be assisted by a medical physicist. Two basic objectives of the RP quality assurance programme are to evaluate patient radiation dose periodically and to monitor occupational radiation dose for workers in cardiology facilities where radiation is used. A senior interventionalist and a medical physicist should be included in the planning of a new cardiology interventional fluoroscopy laboratory. Professional medical bodies (in conjunction with national health and RP authorities) are encouraged to set DRLs that best meet their specific needs and that are consistent with the regional, national or local area to which they apply.
The current work in progress of ICRP C3 is dealing with the following topics: † † † † † † † †
RP in ion beam therapy(15), RP in cone beam CT (in press), Occupational protection in brachytherapy, Justification in imaging, Doses to patients and staff from radiopharmaceuticals (update), Occupational protection in interventional radiology, DRLs for diagnostic and interventional imaging. A document on effective dose (and its use in medicine) in cooperation with other ICRP Committees.
ICRP and especially Committee 3 are aware of the fast evolution of the medical technology when preparing recommendations to help improve radiation safety in the medical field. Many national and international organisations are cooperating with ICRP to achieve this goal, and a relevant effort is made to avoid duplication in the topics addressed by the different organisations.
1. ICRP publication 118. ICRP statement on tissue reactions and early and late effects of radiation in normal tissues and organs—threshold doses for tissue reactions in a radiation protection context. Ann. ICRP 41(1– 2), 1 –322 (2012). 2. Vano, E. Reduction of exposure of patients and staff to radiation during fluoroscopically guided interventional procedures. Curr. Radiol. Rep. 1, 11–22 (2013). 3. International Atomic Energy Agency Radiation protection and safety of radiation sources. International basic safety standards (BSS)—interim edition, IAEA safety standards series GSR part 3 (interim). IAEA (2011). 4. European Directive 2013/59/Euratom on basic safety standards for protection against the dangers arising from exposure to ionising radiation and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom. Off. J. Eur. Commun. L13; 57, 1 –73 (17 Jan 2014). 5. ICRP Publication 103. The 2007 Recommendations of the International Commission on Radiological Protection. Ann. ICRP 37(2–4), 1–332 (2007). 6. ICRP Publication 105. Radiological protection in medicine. Ann. ICRP 37(6), 1 –63 (2007). 7. European Directive 97/43/Euratom on health protection of individuals against the dangers of ionizing radiation in relation to medical exposures and repealing Directive 84/ 466/Euratom. Off. J. Eur. Commun. L180; 40, 22– 27 (9 July 1997). 8. ICRP Publication 85. International Commission on Radiological Protection. Avoidance of radiation injuries from medical interventional procedures. Ann. ICRP 30, 7 –67 (2000). 9. ICRP Publication 93. Managing patient dose in digital radiology. Ann. ICRP 34(1), 1 –73 (2004). 10. ICRP Publication 102. Managing patient dose in multidetector computed tomography (MDCT). Ann. ICRP 37(1), 1– 79 (2007). 11. ICRP Publication 113. Education and training in radiological protection for diagnostic and interventional procedures. Ann. ICRP 39(5), 1– 68 (2009). 12. ICRP Publication 117. Radiological protection in fluoroscopically guided procedures performed outside the imaging department. Ann. ICRP 40(6), 1– 102 (2010). 13. ICRP Publication 120. Radiological protection in cardiology. Ann. ICRP 42(1), 1– 125 (2013). 14. ICRP Publication 121. Radiological protection in paediatric diagnostic and interventional radiology. Ann. ICRP 42(2), 1– 63 (2013). 15. ICRP Publication 127. Radiological protection in ion beam radiotherapy. Ann. ICRP 43(4), 1 –114 (2014).
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doi:10.1093/rpd/ncv030
BASIS FOR STANDARDS: ICRP ACTIVITIES E. Vano* Radiology Department, Medicine Faculty, Complutense University and IdISSC San Carlos Hospital, Madrid 28040, Spain *Corresponding author: [email protected]
The purpose of this chapter is to describe work achieved recently by the International Commission on Radiological Protection (ICRP) and especially by Committee 3 (Protection in Medicine) and its use for standards. In March 1960, the Board of Governors of the International Atomic Energy Agency approved the Agency’s ‘Health and Safety Measures’, stating that the Agency’s ‘Basic Safety Standards’ (BSS) would be based, to the extent possible, on the recommendations of the ICRP. In a similar way, the Council of the European Union took into account the new recommendations of the ICRP when adopting the new Directive 2013/59/EURATOM that laid down BSS for protection against the dangers arising from exposure to ionising radiation. The new limit for the lens of the eyes for occupational exposures has been incorporated into these international standards and several articles dealing with medical exposures: justification, optimisation, recording patient doses, the use of diagnostic reference levels, training, accidental and unintended exposures, etc. have also been included in agreement with the ICRP recommendations.
INTRODUCTION In preparing its recommendations, the International Commission on Radiological Protection (ICRP) takes into account advances in scientific knowledge, evolving social values and practical experience, but the responsibility of formulating standards, regulations and codes of practice lies with other national and international organisations. ICRP consists of a Main Commission (MC), a Scientific Secretariat, and the five following standing Committees: Radiation Effects, Doses from Radiation Exposure, Protection in Medicine, Application of ICRP Recommendations and Protection of the Environment and Task Groups established when needed to undertake specific work (Figure 1). The Committees suggest priorities to produce recommendations on specific topics that the MC finally approves. Once a new draft document is produced, both the approvals of the Committee involved and the MC are required, before a 2–3-month public consultation. Once all the comments received have been considered and the draft has been improved, the document needs final approval from the Committee and the MC before adoption and publication. The Board of Governors of the International Atomic Energy Agency (IAEA) approved the Agency’s ‘Health and Safety Measures’ on March 1960 stating that the Agency’s ‘Basic Safety Standards’ (BSS) would be based, to the extent possible, on the recommendations of the ICRP. In a similar way, the Council of the European Union has taken into account the new recommendations of the ICRP, in particular those included in ICRP Publication
103 to adopt the new Directive 2013/59/EURATOM that laid down BSS for protection against the dangers arising from exposure to ionising radiation. The International BSS and the European BSS have incorporated the new limit of the lens of the eyes for occupational exposures and included several articles dealing with justification, optimisation, recording and reporting patient doses, the use of diagnostic reference levels (DRLs), training, accidental and unintended exposures, etc. in agreement with the ICRP recommendations. The purpose of this chapter is to describe work recently achieved by the ICRP and especially by Committee 3 (Protection in Medicine) and its use for standards, particularly European BSS.
ICRP Committee 3 Protection in Medicine Committee 3 of the ICRP is concerned with protection of persons and unborn children when ionising radiation is used for medical diagnosis, therapy or biomedical research. According to the 2011– 2017 Strategic Plan, Committee 3 develops recommendations and guidance for protection of patients, staff and the public against radiation exposure in medicine. International organisations and stakeholders are encouraged to propose topics of interest for new publications. In addition, a new mechanism, introduced at the 2013 ICRP Symposium, provides opportunities for symposium participants to provide input on suggested topics to the Commission’s committees. Since 2000, Committee 3 has produced, either alone or in conjunction with other ICRP committees,
# The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected]
E. VANO
Figure 1. ICRP structure and Committee 3 mandate.
18 reports dealing with radiological protection (RP) in medicine (abstracts are available at http://www. icrp.org/publications.asp). The reports cover topics on † † † † † †
Education and training in RP; Preventing accidental exposures in radiation therapy; Doses to patients from radiopharmaceuticals; Radiation safety aspects of brachytherapy; Release of patients after therapy with unsealed radionuclides; Managing radiation dose in interventional radiology, digital radiology, computed tomography, paediatrics, cardiology and other medical specialties.
Figure 2 shows the most recent documents published by Committee 3: Publication 117 on Radiological Protection in Fluoroscopically Guided Procedures performed outside the Imaging Department and Publication 120 on Radiological Protection in Cardiology and Publication 121 on Radiological Protection in Paediatric Diagnostic and Interventional Radiology. Publication 113 on Education and Training in Radiological Protection for Diagnostic and Interventional Procedures is also relevant for the potential impact on regulations and guidelines. These documents contain recommendations on patient and staff protection and the relationship between patient and staff. They also address aspects of occupational exposure during pregnancy.
ICRP STATEMENT ON TISSUE REACTIONS Since the statement of the ICRP on tissue reactions (deterministic effects) issued in April 2011(1), several regulatory initiatives and scientific activities have been launched to improve patient and staff radiation safety and to foster optimisation actions especially in fluoroscopy-guided procedures. The ICRP alerted the radiological community to the epidemiological evidence and pointed out some tissue reaction effects when threshold doses are or might be lower than previously considered: 0.5 Gy for the lens of the eye (radiation-induced opacities) and 0.5 Gy for circulatory disease of the heart or brain. Exposure of staff (lens of the eye) and of patients to doses of this magnitude could be reached during complex interventional procedures, and the ICRP recommended particular emphasis be placed on dose optimisation in these circumstances(2). For occupational exposure, the ICRP recommended an equivalent dose limit for the lens of the eye of 20 mSv y – 1, averaged over defined periods of 5 y, with the dose in a single year not exceeding 50 mSv. The immediate consequence was a change in the International BSS(3) and in the European BSS and the adoption of the new limit (4). EXAMPLES OF THE IMPACT OF SOME ICRP RECOMMENDATIONS ON REGULATIONS Some examples of ICRP recommendations now included in the European BSS, in addition to the new
Page 2 of 4
BASIS FOR STANDARDS
Figure 2. The most recent publications of ICRP (Committee 3).
occupational dose limit for the lens of the eyes, could be the following: †
Consideration of occupational and public exposures as part of the justification in medical exposures.
ICRP Publication 103(5) ( paragraph 209) states: ‘The medical use of radiation should be justified, as is any other planned exposure situation, although that justification lies more often with the profession than with government or the competent regulatory authority. The principal aim of medical exposures is to do more good than harm to the patient, due account being taken of the radiation detriment from the exposure of the radiological staff and of other individuals.’ And also in paragraph 330 of the same publication(5) it is said, ‘The principal aim of medical exposures is to do more good than harm to the patient, subsidiary account being taken of the radiation detriment from the exposure of the radiological staff and of other individuals.’ The new European directive on BSS(4) has considered this recommendation in Art. 19(4): ‘Practices involving medical exposure shall be justified both as a class or type of practice, taking into account medical and, where relevant, associated occupational and public exposures.’
patient, the staff, and sometimes the public. However, the choice also alters the scale of resources applied to protection. These resources may be reflected directly in financial costs, but they may also involve less easily quantified societal costs such as other health risks to staff.’ The new European directive on BSS(4) has also considered this recommendation in Art. 32(4): ‘Member States shall ensure that the operational protection of exposed workers is based, in accordance with the relevant provisions of this Directive, on . . . Optimization of radiation protection in all working conditions, including occupational exposures as a consequence of practices involving medical exposures.’ In comparison to the previous Medical Exposures Directive(7) (97/43/Euratom), many other changes introduced in the European BSS(4) (Directive 2013/ 59/Euratom) refer to the following:
Consideration of occupational exposures as part of the optimisation in medical exposures.
† Use of DRLs (including interventional) and their regular review, † Training aspects and the role of Medical Physics Experts in imaging, † Dosimetric information in all diagnostic systems and transfer to the patient report, † Dosimetric information mandatory for all interventional and CT procedures, † Registry and analysis of all the accidental or unintended irradiation of patients.
ICRP Publication 105(6) ( paragraph 69) states: ‘Optimization (medical). The choice of protection option directly alters the level of exposure of the
Some of these changes are in relation to several recommendations included by ICRP in its publications issued in recent years(8 – 14).
†
Page 3 of 4
E. VANO
The ICRP Publication 120 on Radiological Protection in Cardiology(13) included several recommendations considered, in part, by the new European Directive:
ICRP is open to considering new topics suggested during scientific congresses and workshops or by medical and other scientific societies.
†
REFERENCES
† † †
†
† †
Radiation dose data should be recorded in the patient’s medical record after the procedure. Patient dose reports should be archived for quality assurance purposes. Training programmes in RP should include both initial training for all incoming staff, and regular updating and retraining. A cardiologist should have management responsibility for the quality assurance programme aspects of RP for cardiology procedures and should be assisted by a medical physicist. Two basic objectives of the RP quality assurance programme are to evaluate patient radiation dose periodically and to monitor occupational radiation dose for workers in cardiology facilities where radiation is used. A senior interventionalist and a medical physicist should be included in the planning of a new cardiology interventional fluoroscopy laboratory. Professional medical bodies (in conjunction with national health and RP authorities) are encouraged to set DRLs that best meet their specific needs and that are consistent with the regional, national or local area to which they apply.
The current work in progress of ICRP C3 is dealing with the following topics: † † † † † † † †
RP in ion beam therapy(15), RP in cone beam CT (in press), Occupational protection in brachytherapy, Justification in imaging, Doses to patients and staff from radiopharmaceuticals (update), Occupational protection in interventional radiology, DRLs for diagnostic and interventional imaging. A document on effective dose (and its use in medicine) in cooperation with other ICRP Committees.
ICRP and especially Committee 3 are aware of the fast evolution of the medical technology when preparing recommendations to help improve radiation safety in the medical field. Many national and international organisations are cooperating with ICRP to achieve this goal, and a relevant effort is made to avoid duplication in the topics addressed by the different organisations.
1. ICRP publication 118. ICRP statement on tissue reactions and early and late effects of radiation in normal tissues and organs—threshold doses for tissue reactions in a radiation protection context. Ann. ICRP 41(1– 2), 1 –322 (2012). 2. Vano, E. Reduction of exposure of patients and staff to radiation during fluoroscopically guided interventional procedures. Curr. Radiol. Rep. 1, 11–22 (2013). 3. International Atomic Energy Agency Radiation protection and safety of radiation sources. International basic safety standards (BSS)—interim edition, IAEA safety standards series GSR part 3 (interim). IAEA (2011). 4. European Directive 2013/59/Euratom on basic safety standards for protection against the dangers arising from exposure to ionising radiation and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom. Off. J. Eur. Commun. L13; 57, 1 –73 (17 Jan 2014). 5. ICRP Publication 103. The 2007 Recommendations of the International Commission on Radiological Protection. Ann. ICRP 37(2–4), 1–332 (2007). 6. ICRP Publication 105. Radiological protection in medicine. Ann. ICRP 37(6), 1 –63 (2007). 7. European Directive 97/43/Euratom on health protection of individuals against the dangers of ionizing radiation in relation to medical exposures and repealing Directive 84/ 466/Euratom. Off. J. Eur. Commun. L180; 40, 22– 27 (9 July 1997). 8. ICRP Publication 85. International Commission on Radiological Protection. Avoidance of radiation injuries from medical interventional procedures. Ann. ICRP 30, 7 –67 (2000). 9. ICRP Publication 93. Managing patient dose in digital radiology. Ann. ICRP 34(1), 1 –73 (2004). 10. ICRP Publication 102. Managing patient dose in multidetector computed tomography (MDCT). Ann. ICRP 37(1), 1– 79 (2007). 11. ICRP Publication 113. Education and training in radiological protection for diagnostic and interventional procedures. Ann. ICRP 39(5), 1– 68 (2009). 12. ICRP Publication 117. Radiological protection in fluoroscopically guided procedures performed outside the imaging department. Ann. ICRP 40(6), 1– 102 (2010). 13. ICRP Publication 120. Radiological protection in cardiology. Ann. ICRP 42(1), 1– 125 (2013). 14. ICRP Publication 121. Radiological protection in paediatric diagnostic and interventional radiology. Ann. ICRP 42(2), 1– 63 (2013). 15. ICRP Publication 127. Radiological protection in ion beam radiotherapy. Ann. ICRP 43(4), 1 –114 (2014).
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