CATEGORIES IN THE IAEA SAFETY SERIES

A hierarchical categorization scheme beenhas introduced, according whichto publicationsthe IAEAthe in Safety Series groupedare follows:as

Safety Fundamentals (silver cover)

Basic objectives, concepts and principles to ensure safety.

Safety Standards (red cover)

Basic requirements which mus e satisfieb t o ensurdt e safet r particulafo y r activitie r applicatioso n areas.

Safety Guides (green cover)

Recommendations, on the basis of international experience, relating to the fulfilmen f basio t c requirements.

Safety Practices (blue cover)

Practical example detailed san d method applicatioe s useth whice b r dn fo hca n of Safety Standards or Safety Guides.

Safety Fundamentals and Safety Standards are issued with the approval of the IAEA Board of Governors; Safety Guides and Safety Practices are issued under the authorit Directoe th f yo r Genera IAEAe th f o l.

Ther othee ear r IAEA publications which also contain information importano t safety, in particular in the Proceedings Series (papers presented at symposia and conferences) Technicae th , l Reports Series (emphasi technologican so l aspectsd an ) the IAEA-TECDOC Series (information usually in preliminary form). CORRIGENDA to International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources Safety5 Serie11 . sNo

p. 48 In para 14(b. II . ) replace "focal spot position" with "focal spot size",

p. 88 followine footnotn I th d Tablo pareno t ad ea I gtw e I- t nuclide progend san y (firs sixth)d an t : Sr-80 Rb-80 Ag-108m Ag-108

p. 91 In para. H-2 replace "para. 205" with "para. 2.5".

p. 92 In footnote 40 replace "para. 418" with "para. 1-18".

p. 277 In footnot Tablo t ed e II-IX replace "time" with "half-time".

p. 285 In Table IV-II replace "Gy-a"1" with "Sv-a"1".

p. 289 In para. V-l 1 replace "V-ll-V-16" with "V.I 1-V.16".

p. 299 In the definition of Committed effective dose after "integration time t" insert "and W is the

tissue weighting factor for tissue T". T

p. 304 definitioe Inth Healtf no h professional replace "paediatry" with "podiatry".

p. 307 In the definition of Multiple scan average dose replace the limits of integration with "+nI/2" and "-nI/2". p. 319 In the Index spaces not preceded by commas should be inclusive intervals; e.g., "2.10 2.14" shoul "2.10-2.14"e db . p. 319 In the entry for authorized person delete "2.7,". p. 321 Replace the entry for embryo with "embryo/foetus 1.17,1.27, II. 16, II. 18, Table IV-I". p. 322 Replace "foetus (see embryo)" with "foetus (see embryo/foetus)". p. 324 Replace "programme (see protection and safety programme)" with "programme (see pro- tection and safety)".

INTERNATIONAL BASIC SAFETY STANDARDS PROTECTIOR FO N AGAINST IONIZING RADIATION SAFETE TH ANR F YO D FO RADIATION SOURCES

SAFETY 5 SERIE11 . SNo

INTERNATIONAL BASIC SAFETY STANDARDS FOR PROTECTION AGAINST IONIZING RADIATION AND FOR THE SAFETY OF RADIATION SOURCES

Jointly sponsore: dby Food and Agriculture Organization of the United Nations International Atomic Energy Agency International Labour Organisation Nuclear Energy Agence th f yo Organisatio r Econominfo c Co-operatio Developmend nan t Pan American Health Organization World Health Organization

INTERNATIONAL ATOMIC ENERGY AGENCY VIENNA, 1996 Permission to reproduce or translate the information contained in this publica- e obtaineb y tio writiny ma n db e Internationa th o gt l Atomic Energy Agency, Wagramerstrasse 5, P.O. Box 100, A-1400 Vienna, Austria.

IAEA© , 1996

VIC Library Cataloguing in Publication Data International basic safety standard protectior sfo n against ionizing radiatiod nan for the safety of radiation sources. — Vienna : International Atomic Energy Agency, 1996. (Safet— . ycm series4 2 ; , . p ISSN 0074-189 ; 2115 . Safety standards) STI/PUB/996 ISBN 92-0-104295-7 Includes bibliographical references. 1. Radiation—Safety measures—Standards. I. International Atomic Energy Agency. II. Series. III. Series: Safety series. Safety standards.

VICL 95-02815

Printed by the IAEA in Austria February 1996 STI/PUB/996 FOREWORD

These International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources mark the culmination of efforts that have continued ove pase rth t several decades toward harmonizatioe sth radiaf no - tion protectio safetd nan y standards internationally Standarde Th . jointle sar y spon- Fooe soreAgriculturd th dan y db e Organizatio Unitee th f no d Nations (FAO)e th , International Atomic Energy Agency (IAEA) Internationae th , l Labour Organisation (ILO) Nucleae th , r Energy Agenc Organisatioe th f yo r Econominfo c Co-operation and Development (OECD/NEA), the Pan American Health Organization (PAHO) anWorle dth d Health Organization (WHO) (the Sponsoring Organizations). The unprecedented international effort to draft and review the Standards involved hundreds of experts from the Member States of the Sponsoring Organiza- tion frod san m specialized organizations meetine Technicae Th . th f go l Committee that endorsed the Standards in December 1993 was attended by 127 experts from 52 countries and 11 organizations. A further Technical Committee verified the technical translatione editinth d gan s between Englis Arabicd han , Chinese, French, Russia Spanishd nan . The IAEA's Board of Governors approved the Standards at its 847th Meeting on 12 September 1994. For PAHO, the XXIV Pan American Sanitary Conference endorsed the Standards on 28 September 1994 following a recommendation from the 113th Meetin PAHe th f go O Executive Committe Jun8 2 en eo 1994 Directoe Th . r confirmeO FA Genera e FAO'e th d th f o l s technical endorsemen Standarde th f o t s on 14 November 1994. WHO completed its adoption process for the Standards on 27 January 1995 when the Director-General's report on the subject was noted by the Executive Board at its 95th session. The ILO's Governing Body approved publication of the Standards at its meeting on 17 November 1994. The OECD/NEA Steering Committee approve Standarde dth y 1995 s meetinMa it .t 2 a s Thi n go s completed the authorization process for joint publication by all the Sponsoring Organizations. IAEe Th herewitAs i h issuin Standarde gth thein si r final edition, which super- sedes the Interim Edition (Safety Series No. 115-1) issued in December 1994. The Standards are issued in the IAEA Safety Series as a final publication in Arabic, Chinese, English, French, Russia Spanishd nan . EDITORIAL NOTE

The Principal Requirements of these Standards, which presentedare mainthe in body text,ofthe generally formthe 'shall'use makingin statements about requirements, dutiesand obligations. The Detailed Requirements, which are presented in the Appendices, also use 'shall' in statements consequential to the Principal Requirements, with the implication that these requirements apply unless other more desirable options protectionfor safetyand have been established. As exceptions to this general rule, the requirements on or related to the justification of practices of and interventions, statements referring declarationthe to of preg- nancy by female workers and a number of statements on medical exposures use the form 'should' to mean a desired option, and a general condition, for protection and safety. Many Principal Requirements of the Standards are not addressed to any specific party, the implication being that they should be fulfilled by the appropriate party (ies). Conversely, Detailedthe Requirements Appendicesthe in generally specify appropriatethe party (ies) responsible for fulfilling the requirement. The values of committed effective dose per unit intake and the gut transfer factors given in Schedule II are based on the latest information provided by the ICRP and are consistent with the relevant ICRP publications. These values underwent quality assurance checking, as a result of which revisions were made. Please note that the values presented here consequently differ from those published in the Interim Edition of the Standards (Safety Series No. 115-1). The use of particular designations of countries or territories does not imply any judge- ment by the publisher, the IAEA, as to the legal status of such countries or territories, of their authorities institutions delimitationand the of or theirof boundaries. PREFACE

BACKGROUND

Although all the Sponsoring Organizations are involved in the international harmonizatio f radiationo n protectio safetyd n an IAE e th , specificallAs i y authorized unde terme s Statutit th r f o sestabliso et h standard protectioe f safetth o s r fo y f no minimizatioe healtth d han dangef no lifeo r t consultatio n i , n wit Unitee hth d Nations anspecializee dth d agencies concerned t surprisinglyNo . , therefore famile th f n i y,o international governmental organizations firse th , t endeavou establiso t r h standards for radiation protection and safety was made at the IAEA. The Board of Governors e IAEoth f A first approved radiation protectio d safetan n y measure n Marci s h I9601 ,s statewhewa dt i n that "The Agency's basic safety standard . wil.. se b l basedextene th o t ,t possible recommendatione th n o , Internationae th f so l Commis- sion on Radiological Protection (ICRP)". The Board first approved basic safety standard Junn si e 1962; they were publishe IAEe th s SafetAy a db y. 2 Serie9 . sNo A revised version was published in 19673. A third revision was published by the IAEA as the 1982 Edition of Safety Series No. 94; this Edition was jointly sponsored by the IAEA, the ILO, the OECD/NEA and the WHO. In 1990, an important step towards international harmonization of radiation protection and safety took place: an Inter-Agency Committee on Radiation Safety (IACRS) was constituted as a forum for consultation on and collaboration in radia- tion safety matters between international organizations5. The IACRS initially com- prised the Commission of the European Communities (CEC), the Council for Mutual Economic Assistance (CMEA) (now defunct), the FAO, the IAEA, the ILO, the OECD/NEA, the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR WHOe th PAHe d Th . )an O joined subsequently ICRPe Th . , the International Commission on Radiation Units and Measurements (ICRU), the International Electrotechnical Commission (IEC) Internationae th , l Radiation Protec- tion Association (IRPAInternationae th d )an l Organizatio Standardizatior nfo n (ISO)

1 INTERNATIONAL ATOMIC ENERGY AGENCY, The Agency's Health and Safety Measures, INFCIRC/18, IAEA, Vienna (1960); The Agency's Safety Standards and Measures, INFCIRC/18/Rev. 1, IAEA, Vienna (1976). 2 INTERNATIONAL ATOMIC ENERGY AGENCY, Basic Safety Standards for

Radiation Protection, Safety series No. 9, IAEA, Vienna (1962). 3 INTERNATIONAL ATOMIC ENERGY AGENCY, Basic Safety Standards for Radiation Protection (1967 Edition), Safety , IAEASerie9 . No s, Vienna (1967). 4 INTERNATIONAL ATOMIC ENERGY AGENCY, Basic Safety Standards for Radiation Protection (1982 Edition), Safety Series No. 9, IAEA, Vienna (1982). 5 See IAEA Annual Report for 1990, IAEA/GC(XXXV)/953, p. 86. have observer status on the IACRS. The objective of the IACRS is to promote con- sistenc co-ordinatiod yan policief no s with respec followine th o t g area commof so n interest: applying principles, criteri standardd aan radiatiof so n protectio safetd nan y and translating them into regulatory terms; co-ordinating researc developmentd han ; advancing education and training; promoting widespread information exchange; facilitatin e transfeth g f technologo r d know-howan y d providinan ; g servicen i s radiation protection and safety. Within this framework e Sponsorinth , g Organizations establishe a Joind t Secretaria preparatioe th r fo tInternationae th f no l Basic Safety Standard Protecr sfo - tion against Ionizing Radiation and for the Safety of Radiation Sources, the 'Standards', contained in this publication. The Joint Secretariat was co-ordinated by the IAEA e StandardTh . s supersed previoue eth s basic international standardd san reflect knowledge gained subsequentl developmentd yan radiation si n protectiod nan safet related an y d fields. The Standards are based primarily on the recommendations of the ICRP. The ICR a non-governmenta s Pi l scientific organization founde n 192i d establiso 8t h basic principles and recommendations for radiation protection; the most recent recommendations of the ICRP were issued in 19916. Moreover, in relation to safety, the Standards take account of the principles recommende Internationae th y db l Nuclear Safety Advisory Group (INSAG) which, under the auspices of the IAEA, has been elaborating nuclear safety concepts since 1985, such as its Basic Safety Principles for Nuclear Power Plants; many of these

principle relevane sar radiatioo t n source installationd san s other than nuclear instal- 7 lations e quantitieTh . unitd an s se Standard useth n di primarile ar s y those recom- mended by the ICRU, a sister organization of the ICRP. The Standards are published in the IAEA Safety Series. This series of publica- tions encompasses Safety Fundamentals, Safety Standards, Safety Guides and Safety Practices relating to nuclear safety and radiation protection, including radioactive waste management. The IAEA Safety Series includes other related international

standards ,Nucleae sucth s ha r Safet8 y Standards (NUSS r nucleafo ) r power plants, the Regulation Safe th er Transporsfo Radioactivf o t e Material forthcomine th d an , g Radioactive Waste Management Standards (RADWASS) othee Th . r organizationf so

6 INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, 1990 Recommendations of the International Commission on Radiological Protection, Publication

No. 60, Pergamon Press, Oxford and New York (1991). 7 INTERNATIONAL NUCLEAR SAFETY ADVISORY GROUP, Basic Safety Principles for Nuclear Power Plants, Safety Series No. 75-INSAG-3, IAEA, Vienna (1988). 8 The objectives and principles underlying the Standards are summarized in INTER- NATIONAL ATOMIC ENERGY AGENCY, Radiation Protectio Safete th f Radiad yo nan - tion Sources: Safety Fundamentals, Safety Series No. 120, IAEA, Vienna (1996). the Joint Secretariat have also produced code guided san thein si r respective spheres of activity. Notably, the ILO has issued a code of practice for the radiation protection of workers as well as other relevant publications; the PAHO and the WHO have issued a number of documents relating to the safety of workers and patients in medi- cal applications of radiation; the FAO and the WHO have established, through the Codex Alimentarius Commission, guideline levels for radioactive substances in foodstuffs movin internationan gi OECD/NEe l tradeth d an ; s publisheAha d docu- ments on specific topics relating to radiation protection and safety.

OBJECTIVE

The purpose of the Standards is to establish basic requirements for protection against the risks associated with exposure to ionizing radiation (hereinafter termed safete radiationth f radiatior o y fo d an )n sources delivey thama t r such exposure. The Standards have been developed from widely accepted radiation protection and safety principles, such as those published in the Annals of the ICRP and the IAEA Safety Series. They are intended to ensure the safety of all types of radiation sources and, in doing so, to complement standards already developed for large and complex radiation sources, suc nucleas ha r reactor radioactivd san e waste manage- ment facilities. For these sources, more specific standards, such as those issued by the IAEA, are typically needed to achieve acceptable levels of safety. As these more specific standards are generally consistent with the Standards, in complying with them, such more complex installations will also generally comply with the Standards. The Standards are limited to specifying basic requirements of radiation protec- tion and safety, with some guidance on how to apply them. General guidance on applying some of the requirements is available in the publications of the Sponsoring Organizations and additional guidance will be developed as needed in the light of experience gained in the application of the Standards.

SCOPE

The Standards comprise basic requirements to be fulfilled in all activities involving radiation exposure requiremente Th . s hav force eth e tha derives i t d from the statutory provisions of the Sponsoring Organizations. They do not entail any obli- gatio r Statenfo brino st g their legislation into conformity wit hthee themar yr no , intende replaco dt provisione eth f nationaso l law r regulationsso standarde th r o , s in force. The e aimeyar d rathe serv o t practicara s ea l guid r publiefo c authorities and services, employer d workersan s , specialized radiation protection bodies, enterprises and safety and health committees. The Standards lay down basic principles and indicate the different aspects that should be covered by an effective radiation protection programme. They are not intende appliee b o dt thes da y l countriestanal n di regionsd san t shoulbu , intere db - prete tako dt e accoun f locao t l situations, technical resources scale th ,f installa eo - tion othed an s r factors which will determin e potentiaeth r applicationfo l . Standarde Th s cove broaa r d rang f practiceeo sourced san s that give riso et or could give rise to exposure to radiation, and many of the requirements have there- fore been drafte generan di l terms t followI . s thagivey an t n requiremen havy ma te to be fulfilled differently for different types of practice and source, according to the naturoperatione th potentiaf e eo th d exposures r srequirementan e fo l th l al t .No s will apply to every practice or to every source, and it is up to the appropriate Regulatory Authority to specify which of the requirements are applicable in each case. Standarde scope th Th f eo limites si protectioe th o dt f humano n beings only; it is considered that standards of protection that are adequate for this purpose will also ensure that no other species is threatened as a population, even if individuals of the species may be harmed. Moreover, the Standards apply only to ionizing radia- tion, namely gamma and X rays and alpha, beta and other particles that can induce ionization t .appl Theno non-ionizino yo t y d g radiation suc s microwaveha , ultra- violet, visible lighinfrared an t d radiation t appl. Theno yo yd controe eithe th o t r l of non-radiological aspects of health and safety. The Standards recognize that radia- tion is only one of many sources of risk in life, and that the risks associated with radiation shoul t onl dweighede no y b agains benefits tit t alssbu o viewe perspecn di - tive with other risks.

STRUCTURE

The Standards comprise a Preamble, the Principal Requirements, Appendices and Schedules Preambl.The e Standardsstatebase the the aim sof the sand , explains the underlying principle philosophyd an s described an , s appropriate governmental arrangement r applyinsfo Standardse gth Principae Th . l Requirements specify what is imperativ orden ei e Standardsfulfio t re aimth th f l o s . Consequential Detailed Requirements, subsidiary to the Principal Requirements, are specified in the Appendices. Quantitative standards and guidance are provided in the Schedules. A Glossary lis e f experto th t, contributeo swh draftine th revieo d dt an g w process, and the list of the representatives of countries and organizations on the Technical Committees which endorse Standarde dth Decemben si r 199 whicd 3an h verifiee dth translations and technical editing of the Standards in August/September 1994 are also included Sponsorine Th . g Organization alse sar o briefly described. CONTENTS

PREAMBLE: PRINCIPLES AND FUNDAMENTAL OBJECTIVES ...... 1

PRINCIPAL REQUIREMENTS ...... 11

1. GENERAL REQUIREMENTS ...... 13 Definitions ...... 13 Purpose ...... 13 Scope ...... 3 1 . Exclusions ...... 13 Responsible parties ...... 14 Inspections ...... 5 1 . Non-compliance ...... 15 Entry into force ...... 16 Resolutio f conflictno s ...... 6 1 . Interpretation ...... 16 Communications ...... 16

2. REQUIREMENTS FOR PRACTICES ...... 17 Application ...... 17 Basic obligations ...... 9 1 . Administrative requirements ...... 9 1 . Radiation protection requirements ...... 22 Management requirements ...... 24 Technical requirements ...... 25 Verification of safety ...... 27

. 3 REQUIREMENT INTERVENTIOR SFO N ...... 8 2 . Application ...... 28 Basic obligations ...... 8 2 . Administrative requirements ...... 29 . Radiation protection requirements ...... 0 3 .

APPENDICES: DETAILED REQUIREMENTS ...... 31

Appendix I: OCCUPATIONAL EXPOSURE ...... 33 Responsibilities ...... 3 3 . Conditions of service ...... 35 Classification of areas ...... 36 Local rule supervisiod an s n ...... 8 3 . Personal protective equipment ...... 38 Co-operation between employers, registrantd an s licensees ...... 9 3 . Individual monitorin exposurd gan e assessment ...... 0 4 . Monitoring of the workplace ...... 40 Health surveillance ...... 1 4 . Records ...... 41 Special circumstances ...... 2 4 .

Appendix H: MEDICAL EXPOSURE ...... 45 Responsibilities ...... 5 4 . Justification of medical exposures ...... 45 Optimizatio f protectiono r medicanfo l exposures ...... 7 4 . Guidance levels ...... 53 Dose constraints ...... 54 Maximum activit r patientyfo therapn si n yo discharge from hospital ...... 54 Investigation of accidental medical exposures ...... 55 Records ...... 5 5 .

Appendix IH: PUBLIC EXPOSURE ...... 57 Responsibilities ...... 7 5 . Control of visitors ...... 58 Sources of external irradiation ...... 59 Radioactive contamination in enclosed spaces ...... 59 Radioactive waste ...... 9 5 . Discharg f radioactiveo e substance environmene th 0 o st 6 . . t Monitorin f publigo c exposure ...... 1 6 . Consumer products ...... 2 6 .

Appendi : xIV POTENTIA L EXPOSURE: SAFET SOURCEF YO S ...3 .6 Responsibilities ...... 3 6 . Safety assessment ...... 63 Requirement r desigfo s n ...... 4 6 . Requirements for operations ...... 67 Quality assurance ...... 9 6 .

Appendix V: EMERGENCY EXPOSURE SITUATIONS ...... 71 Responsibilities ...... 71 Emergency plans ...... 71 Interventio r emergencnfo y exposure situations ...... 2 7 . Assessmen monitorind an t g after accidents ...... 5 7 . Cessation of intervention after an accident ...... 75 Protection of workers undertaking an intervention ...... 75

Appendi : xVI CHRONI C EXPOSURE SITUATIONS ...... 7 7 . Responsibilities ...... 77 Remedial action plans ...... 7 7 . Action levels for chronic exposure situations ...... 77

SCHEDULES ...... 9 7 .

Schedule I Exemptions ...... 81 Schedule II Dose limits ...... 91 Schedule III Guidance levels of dose, dose rate and activity for medical exposure ...... 279 Schedul V eI Dose level t whica s h interventio expectes ni e b o dt undertaken under any circumstances ...... 285 Schedul eV Guideline r interventiofo s n level actiod an s n levels in emergency exposure situations ...... 287 Schedul I eV Guideline r actiofo s n level chronin i s c exposure situations ...... 1 29 .

GLOSSARY ...... 293

INDEX ...... 7 31 .

CONTRIBUTOR DRAFTINGO ST , REVIEW, ENDORSEMENT AND VERIFICATION ...... 329

PREAMBLE: PRINCIPLES AND FUNDAMENTAL OBJECTIVES

beenIthas recognized since early studies raysradioactiveX and on minerals that exposure highto levels radiationof causecan clinical damage tissuesthe to of the human body. In addition, long term epidemiological studies of populations exposed to radiation, especially the survivors of the atomic bombing of Hiroshima and Nagasaki Japanin 1945,in have demonstrated that exposure radiationto also potentiala delayedthe has for induction of malignancies. thereforeis It essential that activities involving radiation exposure, such as the production and use of radiation sources radioactiveand materials, operationthe and nuclearof installations, including managementthe radioactiveof waste, subjectbe certainto standardsof safety in order to protect those individuals exposed to radiation. Radiation radioactiveand substances naturalare permanentand featuresof environment,the thus risksand the associated with radiation exposure onlycan be restricted, not eliminated entirely. Additionally, the use of human made radiation is widespread. Sources of radiation are essential to modern health care: disposable medical supplies sterilized intenseby radiation have been central combatingto disease; radiology is a vital diagnostic tool; and radiotherapy is commonly part of treatmentthe malignancies.of nuclearof use energyThe applicationsand its of by-products, i.e. radiation radioactiveand substances, continue increaseto around the world. Nuclear techniques are in growing use in industry, agriculture, medicine and many fields of research, benefiting hundreds of millions of people and giving employment millionsto peoplerelatedof the in occupations. Irradiation usedis around worldthe preserveto foodstuffs reduceand wastage, sterilizationand techniques have been used eradicateto disease carrying insects pests.and Industrial radiography is in routine use, for example to examine welds and detect cracks and help prevent failurethe engineeredof structures. The acceptance societyby risksof associated with radiation conditionalis on the benefits to be gained from the use made of radiation. Nonetheless, the risks must restrictedbe protectedand against applicationthe by radiationof safety standards. The Standards provide a desirable international consensus for this purpose. The Standards draw upon information derived from extensive researchand development work scientificby engineeringand organizations, nationalat inter-and national levels, on the health effects of radiation and on techniques for the safe design operationand radiationof sources; drawand upon experience manyin countries in the use of radiation and nuclear techniques. The United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), a body set up Unitedbythe Nations 1955,in compiles, assesses disseminatesand informationon healththe effects radiationof levels on radiationof and exposure differentto due sources; this information was taken into account in developing the Standards. Purely

1 PREAMBLE

scientific considerations, however, are only part of the basis for decisions on protec- tion and safety, and the Standards implicitly encourage decision makers to make value judgements about the relative importance of risks of different kinds and about balancingthe risks of benefits. and

RADIATION EFFECTS

Exposure radiationto highat doses causecan effects such nausea,as redden- ing severe in skin ofthe or, cases, more acute syndromes thatclinicallyare expressed in exposed individuals within shorta period timeof afterexposure.the Such effects are termed 'deterministic effects' because they are certain to occur if the dose exceeds thresholda level. Radiation exposure alsocan induce somatic effects such malignanciesas which expressedare after latencya epidemiologi-be periodmay and cally detectable population;a in this induction assumedis taketo place overthe entire range of doses without a threshold level. Also, hereditary effects due to radia- tion exposure have been statistically detected otherin mammalian populationsand are presumed to occur in human populations also. These epidemiologically detect- able effects — malignancies and hereditary effects — are termed 'stochastic effects' because theirof random nature. Deterministic effects are the result of various processes, mainly cell death and delayed cell division, caused exposureby highto levels radiation.of extensiveIf enough, these can impair the function of the exposed tissue. The severity of a particu- deterministiclar exposedan effectin individual increases with dosethe abovethe threshold occurrencethe effect.for the of Stochastic ensueeffectsmay irradiated ifan cell modifiedis rather than killed. Modified cells may, after prolongeda process, develop into cancer.a body'sThe repair defenceand mechanisms make this verya improbable outcome smallat doses; nevertheless, there is no evidence of a threshold dose below which cancer cannot result. The probability of occurrence of cancer is higher for higher doses, but the severity of any cancer that may result from irradiation is independent of the dose. If the cell damaged by radiation exposure is a germ cell, whose function is to transmit genetic information to progeny, it is conceivable that hereditary effects of various types may develop in the descendants of the exposed individual. The likelihood of stochastic effects is presumed to be proportional to the dose received, without a dose threshold. In addition aforementionedthe to health effects, other health occureffectsmay in infants due to exposure of the embryo or foetus to radiation. These effects include a greater likelihood leukaemiaof and, exposurefor above various threshold dose values during certain periods of pregnancy, severe mental retardation congenitaland malformations. PRINCIPLES AND FUNDAMENTAL OBJECTIVES 3

Since a small likelihood of occurrence of stochastic effects at even the lowest doses assumed,is Standardsthe cover entirethe range dosesof with constrainingof aim radiationthe any detriment arise.that manymay The aspects of the concept of radiation detriment make it undesirable to select any single quantity representto Standards The it. therefore are basedconcepta on detri-of ment recommendedas ICRP,the by which stochasticfor effects includesthe following quantities: probabilitythe fatalof cancer attributable radiationto exposure; weightedthe probability incurringof non-fatala cancer; weightedthe probability severeof hereditary length the effects; lifetimeof and harmlostthe if occurs.

PRACTICES AND INTERVENTIONS

Human activities thatradiationadd exposure thatto which people normally backgroundincurto due radiation, thator increase likelihoodthe of their incurring exposure, termedare "practices' Standards.the in human The activities that seek to reduce the existing radiation exposure, or the existing likelihood of incurring exposure which is not pan of a controlled practice, are termed 'interventions'. The Standards apply both to commencement the continuationthe and of practices that involve or could involve radiation exposure, and also to existing de facto situations whichin exposure likelihoodits reducedbe or preventedcan or by means of some intervention. For a practice, provisions for radiation protection madebe safetyand can before commencement,its associatedthe and radiation exposures theirand likelihood restrictedbe can from outset.casethe the In of inter- vention, the circumstances giving rise to exposure or the likelihood of exposure already exist, theirand reduction only achievedcan be meansby remedialof or protective actions. The practices whichfor Standardsthe intendedare include following:the activities involving the production of radiation sources; the use of radiation and radioactive substances in medicine, research, industry, agriculture and teaching; generationthe nuclearof power, including entirethe cycle relatedof activities from the mining and processing of radioactive ores to the operation of nuclear reactors fueland cycle facilities managementthe and of radioactive wastes; activities,and underground the such as mining phosphaticof coalof and and other minerals, enhancethatmay exposure naturallyto occurring radioactive substances. Situations requirethatmay intervention include: chronic exposure naturallyto occurring sources radiationof such radonas dwellings,in to and radioactive residues from past activities events; and emergency and exposure situations such as might result from accidents or from deficiencies in existing practices. 4 PREAMBLE

TYPES OF RADIATION EXPOSURE

It is virtually certain that some radiation exposures will result from the normal performance of practices and that their magnitudes will be predictable, albeit with some degree of uncertainty: such expected exposures are referred to in the Standards as 'normal exposures'. Also, exposure scenarios can be envisaged for which there is a potential for exposure, but no certainty that an exposure will in fact occur; such unexpected feasiblebut exposures termedare 'potential exposures'. Potential exposures can become actual exposures if the unexpected situation does occur; for example as a consequence of equipment failure, design or operating errors, unforeseenor changes environmentalin conditions, a disposale.g. at site for radioactive waste. If the occurrence of such events can be foreseen, the probability theirof occurrence resultingthe and radiation exposurebe can estimated. The means specified in the Standards for controlling normal exposures is the restriction of the doses delivered. The primary means for controlling potential exposures goodby is design installations,of equipment operatingand procedures; this intendedis restrictto probabilitythe occurrenceof eventsof that could leadto unplanned exposures and to restrict the magnitudes of the exposures that could result if such events were to occur. The relevant radiation exposures coveredStandardsthe by encompassthe exposures, both normal potential,and workersof pursuing their occupations,of patients diagnosisin treatment,or of membersand affectedbe public may of the who byintervention.practicea an by or interventionFor situations exposurethe be can chronic or, in some cases of emergencies, temporary. Thus exposures are divided into: 'occupational exposures' which are incurred at work and principally as a result of work; 'medical exposures' which are principally exposures of patients in diagnosis or treatment; and 'public exposures' which comprise all other exposures. The Standards intendedare exposed be coverto radia-peopleto may all who tion, including those futurein generations could affectedwho be present by practices or interventions.

BASIC PRINCIPLES

The principles radiationof protection safety whichand on Standards the are based are those developed by the ICRP and by INSAG. The detailed formulation of these principles can be found in the publications of these bodies and they cannot easily be paraphrased without losing their essence. However, a brief — although simplified — summary of the principles is as follows: a practice that entails or that could entail exposure to radiation should only be adopted if it yields sufficient benefit to the exposed individuals or to society to outweigh the radiation detriment it causes PRINCIPLE FUNDAMENTAD SAN 5 L OBJECTIVES

or could cause (i.e. the practice must be justified)1; individual doses due to the combination of exposures from relevantall practices should exceednot specified dose limits; radiation sources installationsand should providedbe with bestthe available protection safetyand measures under prevailingthe circumstances, thatso the magnitudes and likelihood of exposures and the numbers of individuals exposed be as low as reasonably achievable, economic and social factors being taken into account, and the doses they deliver and the risk they entail be constrained (i. e. pro- tection safetyand should optimized);be radiation exposure sourcesto due radia- of tion partpracticea not of that are should reducedbe interventionby when thisis justified, and the intervention measures should be optimized; the legal person autho- rized to engage in a practice involving a source of radiation should bear the primary responsibility protectionfor safety;and safetya culture should inculcatedbe that governs the attitudes and behaviour in relation to protection and safety of all individuals organizationsand dealing with sources radiation;of in-depth defensive measures should be incorporated into the design and operating procedures for radia- tion sources to compensate for potential failures in protection or safety measures ;and protection and safety should be ensured by sound management and good engineer- ing, quality assurance, training qualificationand of personnel, comprehensive safety assessments attentionand lessonsto learned from experience research.and

QUANTITIE UNITD SAN S

Although most of the requirements of the Standards are qualitative, the Standards also establish quantitative limits, and guidance levels. For these purposes, the main physical quantities used in the Standards are the rate of nuclear transforma- tion of radionuclides (the activity) and the energy absorbed by a unit mass of a sub- stance from radiationthe whichto exposedis it (the absorbed dose). unitThe of activity is the reciprocal second, representing the number of nuclear transformations (or disintegrations) per second, which is termed the becquerel (Bq). The unit of absorbed dose is the joule per kilogram, termed the gray (Gy). The absorbed dose is the basic physical dosimetric quantity of the Standards. However, entirelynot is it satisfactory radiationfor protection purposes because effectiveness damagingin human tissue differs differentfor types ionizingof radia- tion. Consequently, the absorbed dose averaged over a tissue or organ is multiplied by a radiation weighting factor to take account of the effectiveness of the given type of radiation in inducing health effects; the resulting quantity is termed the equivalent

1 Usually, compliance with the principle of justification is adequately demonstrated in respect of a type of activity by the existence or the laying down of regulations specifically concerning type activity.the of 6 PREAMBLE

dose. The quantity equivalent dose is used when individual organs or tissues are irradiated, likelihoodthe but of injurious stochastic givena to effects equivalentdue dose differs for different organs and tissues. Consequently, the equivalent dose to each organ tissueand multipliedis tissuea by weighting factor taketo accountof organ'sthe radiosensitivity. totalsum of The such weighted equivalent dosesall for exposed tissues in an individual is termed the effective dose. The unit of equivalent dose and of effective dose is the same as that of absorbed dose, namely joule per kilo- namegram,the but sievert (Sv) usedis orderin avoidto confusion with unitthe of absorbed dose (Gy). When radionuclides are taken into the body, the resulting dose is received throughout the period of time during which they remain in the body. The committed dose is the total dose delivered during this period of time, and is calculated as a specified time integral rate ofthe of receipt dose. ofrelevantthe Any dose restriction is appliedcommittedthe to dose from intake.the The total impactradiationthe of givenexposurea to practicedue sourceor depends numberthe on of individuals dosesthe exposedon theyand receive. col-The lective dose, defined as the summation of the products of the mean dose in the various groups of exposed numberpeoplethe and of individuals eachin group, thereforemay be used to characterize the radiation impact of a practice or source. The unit of collective dose is the man-sievert (man-Sv).

GOVERNMENTAL REGULATION

The Standards are intended to place requirements on those legal persons authorized to conduct practices that cause radiation exposure or to intervene in order reduceto existing exposures; these legal persons have primarythe responsibilityfor applying the Standards. Governments, however, have responsibility for their enforcement, generally through a system that includes a Regulatory Authority, and for planning and taking actions in different circumstances. In addition, Governments generally provide for certain essential services for radiation protection and safety interventionsfor and that exceed thator complement capabilitiesthe legalthe of persons authorized conductto practices. The Standards are based therefore on the presumption that a national infra- structure placein is enabling Governmentthe dischargeto responsibilitiesits for radiation protection and safety.

NATIONAL INFRASTRUCTURES

Essential parts nationala of infrastructure are: legislation regulations;and Regulatorya Authority empowered authorizeto inspectand regulated activitiesand to enforce the legislation and regulations; sufficient resources; and adequate PRINCIPLES AND FUNDAMENTAL OBJECTIVES 7

numbers of trained personnel. infrastructuresThe must also provide ways meansand of addressing societal concerns which extend beyond legalthe responsibilities ofthe legal persons authorized to conduct practices involving sources of radiation. For example, national authorities ensure that appropriate arrangements are made for detecting buildupany radioactiveof substances generalthe in environment,for disposing radioactiveof preparingwastesfor and interventions,for particularly during emergencies that could result exposurein generalthe of public. They also need provide controlto the for of sources of radiation whichfor otherno organiza- tion has responsibility, such as natural sources and radioactive residues from past practices. National infrastructures must provide adequatefor arrangements madebe to by those responsible for the education and training of specialists in radiation protec- exchangethe tionsafety, and for well as informationof as among specialists. A related responsibility is to set up appropriate means of informing the public, its representatives and the information media about the health and safety aspects of activities involving exposure radiationto aboutand regulatory processes. This pro- vides information to facilitate the political process of setting national priorities and allocating resources protectionfor safetyalsoand and helps maketo regulatory the process more readily understandable. National infrastructures must also provide facilities and services that are essential for radiation protection and safety, but are beyond the capabilities required of the legal persons who are authorized to conduct practices. Such facilities and services include those needed intervention,for personal dosimetry environmentaland monitoring, calibrationfor and intercomparisonand of radiation measuring equip- ment. Services could include provisionthe centralof registries occupationalfor exposure records and the provision of information on equipment reliability. The pro- vision of such services at the national level does not detract from the ultimate respon- sibility for radiation protection and safety borne by the legal persons authorized to conduct the practices.

REGULATORE TH Y AUTHORITY

Fullproperand implementation Standardsthe of requires that Regulatorya Authority be established by the Government to regulate the introduction and conduct practiceofany involving sources of radiation. Such Regulatorya Authority mustbe provided with sufficient powers and resources for effective regulation and should be independent of any Government departments and agencies that are responsible for the promotion and development of the practices being regulated. The Regulatory Authority must also be independent of registrants, licensees and the designers and constructors radiationthe of sources used practices.in effectiveThe separationof responsibilities between the Junctions of the Regulatory Authority and those of any 8 PREAMBLE other madebe partyto clearis thatregulatorsso the retain their independenceof judgement decisionand safetyas authorities. The Standards are worded on the assumption that a single Regulatory Authority is responsible aspectsall for of radiation protection safetycountry.a and in someIn countries, however, regulatory responsibility differentfor practices differentor aspects radiationof protection dividedbe safetyand may between different authori- ties. Consequently, termthe Regulatory Authority generallyis Standards usedthe in to mean the relevant Regulatory Authority for the particular source or aspect of radiation safety in question. Regardless of the division of regulatory responsibilities, the government must ensure that aspectsall covered;are example,for mustit ensure that a specific body is assigned responsibility for the regulatory surveillance of protection safetyand measures patients qualityfor of and assurance measuresfor equipment techniquesand medicalfor uses radiation.of The type of regulatory system adopted in a country will depend on the size, complexity and safety implications of the regulated practices and sources, as well as on the regulatory traditions in the country. The mechanism for carrying out regula- tory duties may vary, with some authorities being completely self-sufficient and others delegating some inspection, assessment otheror duties variousto governmen- tal, public privateor agencies. RegulatoryA Authority also self-sufficientmay be in specialist consultexpertisemay it expertor advisers advisoryand committees. The general functions Regulatorythe of Authority include following:the the assessment of applications for permission to conduct practices that entail or could entail exposure to radiation; the authorization of such practices and of the sources associated with them, subject to certain specified conditions; the conduct of periodic inspections to verify compliance with the conditions; and the enforcement of any necessary actions ensureto compliance with regulationsthe standards.and theseFor purposes, mechanisms are needed for notification, registration and licensing of the sources within practices, with provision exclusionthe for exemptionor of sourcesor practices from regulatory requirements under certain conditions. Provision is also surveillance,neededthe for monitoring, review, verification inspectionand of sourcesensuringfor and that adequate plans exist dealingfor with radiation acci- dents and carrying out emergency interventions. The effectiveness of radiation pro- tection and safety measures for each authorized practice and the total potential impact authorizedof practices assessed.needbe to The powers inspectorsthe Regulatoryof the of Authority must wellbe defined and consistency enforcementof must maintained,be with provision appealfor by those responsible for sources. Directives to both inspectors and regulated legal persons must clear. be Regulatory The Authority need providemay to guidanceon how certain regulatory requirements are to be fulfilled for various practices, for example in regulatory guideline documents. An attitude of openness and co-operation must be fostered between regulated legal persons and inspectors, which includes facilitating access by inspectors to premises and to information. PRINCIPLE FUNDAMENTAD SAN 9 L OBJECTIVES

An additional responsibility of the Regulatory Authority is to require all parties involved developto safetya culture that includes: individual collectiveand commit- ment to safety on the part of workers, management and regulators; accountability of all individuals for protection and safety, including individuals at senior manage- ment level; and measures to encourage a questioning and learning attitude and to discourage complacency with respect to safety. Due account needs to be taken by both the Regulatory Authority and the regu- lated legal persons generalof developments experiencenew of and radiationin protection and the safety of sources.

PRINCIPAL REQUIREMENTS

1. GENERAL REQUIREMENTS

DEFINITIONS

1.1. Terms shall be interpreted as defined in the Glossary.

PURPOSE

1.2. These Standards specify the basic requirements for protection of people against exposure to ionizing radiation and for the safety of radiation sources, here- inafter termed protection and safety.

SCOPE

1.3. The Standards apply to practices, including any sources within the practices, and interventions which are: (a) Stata carrien i e t thadou t choose adopo t s Standarde th t r requestso f o y an s the Sponsoring Organizations to provide for the application of the Standards; (b) undertaken by States with the assistance of the FAO, the IAEA, the ILO, the PAHO WHOe lighe th th f relevanr o o tn , i , t national rule regulationsd san ; (c) carried out by the IAEA or involve the use of materials, services, equipment, facilities and non-published information made available by the IAEA or at its request or under its control or supervision; or (d) carried out under any bilateral or multilateral arrangement whereby the parties request the IAEA to provide for the application of the Standards.

EXCLUSIONS

1.4. Any exposure whose magnitude or likelihood is essentially unamenable to control through the requirements of the Standards is deemed to be excluded from the Standards2.

2 Examples are exposure from "^K in the body, from cosmic radiation at the surface earte ofrod th f han m unmodified concentration f radionuclideso mosn materialsi sw ra t .

13 4 1 PRINCIPAL REQUIREMENTS

RESPONSIBLE PARTIES

1.5. The Regulatory Authority and, in the case of intervention, the Intervening Organizations shall be responsible for the enforcement of the Standards. 1.6. The principal parties having the main responsibilities for the application of the Standards shal: be l (a) registrants or licensees; and (b) employers. 1.7. Other parties shall have subsidiary responsibilities for the application of the Standards. These partie includey ma s appropriates a , :

(a) suppliers; (b) workers; (c) radiation protection officers; (d) medical practitioners; (e) health professionals; (f) qualified experts; (g) Ethical Review Committees; and (h) any other party to whom a principal party has delegated specific respon- sibilities. 1.8. The parties shall have the general and specific responsibilities set out in the Standards. e generaTh 1.9l. responsibilitie f principao s l parties, withi e requirementth n s specified by the Regulatory Authority, are: establiso t (a) h protectio safetd nan y objective conformitn si y wit e relevanhth t requirements of the Standards; and developo t (b) , implemen documend tan protectiota safetd nan y programme com- mensurate wit nature h th extenrisk d e th ean f s o tassociate d wit practicee hth s and interventions under their responsibility and sufficient to ensure compliance wit e requirementhth Standardse th f so , and, within this programme: determino t (i) measuree eth resourced san s neede achievo dt protectioe eth n and safety objective ensuro t d sean tharesourcee th t providee sar d dan the measures properly implemented; (ii) to keep such measures and resources continually under review, and regu- larl o verift y y thae protectioth t d safetan n y objective e beinar s g achieved; (iiio identift ) y failurean y d shortcomingan s e protectioth n i s d safetynan measure resourcesd san tako t ed stepan , correco st t the prevend man t their recurrence; 1. GENERAL REQUIREMENTS 15

(iv) to establish arrangements, through representatives if appropriate, for facilitating consultatio co-operatiod an n n betwee l relevanal n t parties with respec protectioo t t safetyd nan d an ; (v) to keep appropriate records regarding the discharge of their responsibilities.

INSPECTIONS

1.10. The principal parties shall permit duly authorized representatives of the Regulatory Authority, and of the relevant Sponsoring Organizations when applic- able, to inspect their protection and safety records and to carry out appropriate inspection f theio s r authorized activities.

NON-COMPLIANCE

1.11. In the event of a breach of any applicable requirement of the Standards, principal parties shall, as appropriate:

(a) investigate the breach and its causes, circumstances and consequences; (b) take appropriate actio remedo nt circumstancee yth breace th d so t h an tha d le t preveno t recurrenca t f similaeo r breaches; (c) communicat e Regulatorth o t e y e relevanAuthorityth o t td Sponsorinan , g Organizations when applicable, on the causes of the breach and on the correc- tive or preventive actions taken or to be taken; and (d) take whatever other action necessare sar s requirey a Standardse th y db . 1.12. The communication of a breach of the Standards shall be prompt and it shall e immediatb e wheneve n emergenca r y exposure situatio s developeha n s i r o d developing. 1.13. Failur tako et e correctiv preventivr eo e actions withi reasonablna e timn ei accordance with national regulations shal grounde b l modifyingr sfo , suspendinr go withdrawin authorizatioy gan n thabeed tha n grante Regulatore th y db y Authorit, yor when applicable, by the relevant Sponsoring Organization. 1.14. Wilful breac , attemptehof d breac r conspiraco f ho breaco yt requirey han - ment of the Standards shall be subject to the provisions for such infractions by the appropriate national legislatio Regulatore th Statee y b th r f no ,o y Authorit , wheyor n applicable relevane th y b , t Sponsoring Organization. 16 PRINCIPAL REQUIREMENTS

ENTRY INTO FORCE

1.15. The Standards shall come into force one year after the date of their adoption or acknowledgement, as appropriate, by the relevant Sponsoring Organization. 1.16. Shoul dStata e choos adopo et Standardse tth Standarde th , s shall come into force at the time indicated in the formal adoption by that State. 1.17. If a modification to an existing practice or source is required by the Regula- tory Authority or, where applicable, by the relevant Sponsoring Organization, in order to comply with some requirement of the Standards, such a requirement shall take effect within an approved period if such a period is required for the modification.

RESOLUTIO CONFLICTF NO S e requirement1.18Th placn .i Standard e t f th eo no additiof n i o sd e an ar s o nt other applicable requirements, suc s thosha f relevaneo t binding conventiond an s national regulations. 1.19. In cases of conflict between the requirements of the Standards and other applicable requirements, the Regulatory Authority shall determine which require- ment is to be enforced. 1.20. Nothing in the Standards shall be construed as restricting any actions that may otherwis necessare eb r protectioyfo safetyd nan .

INTERPRETATION

1.21. Excep specificalls a t y authorize statutore th y db y Governing Bod relea f yo - vant Sponsoring Organization interpretatioo n , Standarde th officey f no an r y o rsb employee of the Sponsoring Organization other than a written interpretation by the Director Genera Sponsorine th f o l g Organization wil bindine Sponsorine b l th n go g Organization.

COMMUNICATIONS

1.22. The appropriate responsible party, as established by the Standards, shall report on compliance with the requirements of the Standards. 1.23. Reports on compliance and other communications on official interpretation of the Standards shall be addressed to the Regulatory Authority or the relevant Sponsoring Organizations, as appropriate. . REQUIREMENT2 PRACTICER SFO S

APPLICATION

Practices

2.1. The practices to which the Standards shall apply include: (a) the production of sources and the use of radiation or radioactive substances for medical, industrial, veterinary or agricultural purposes, or for education, train- ing or research, including any activities related to that use which involve or could involve exposure to radiation or radioactive substances; (b) the generation of nuclear power, including any activities in the nuclear fuel cycle which involve or could involve exposure to radiation or radioactive substances; (c) practices involving exposure to natural sources specified by the Regulatory Authority as requiring control; and (d) any other practice specified by the Regulatory Authority.

Sources sourcee Th 2.2s . withi practicy nan whico et requiremente hth r practicesfo f so Standarde th s shall apply include: (a) radioactive substances and devices that contain radioactive substances or produce radiation, including consumer products, sealed sources, unsealed sources, and radiation generators, including mobile radiography equipment; (b) installations and facilities which contain radioactive substances or devices which produce radiation, including irradiation installations, mines and mills processing radioactive ores, installations processing radioactive substances, nuclear installations radioactivd an , e waste management facilitiesd an ; (c) any other source specified by the Regulatory Authority. 2.3. The requirements of the Standards shall apply to each individual source of radiation withi installation na complete th r facilitno o t d e yan installatio r facilitno y regarded as a source, as appropriate, according to the requirements of the Regulatory Authority.

Exposures exposuree Th 2.4 . whico st requiremente hth Standarde th f o s y s applan e yar occupational exposure, medical exposure or public exposure due to any relevant practice or source within the practice, including both normal exposures and potential exposures.

17 8 1 PRINCIPAL REQUIREMENTS

2.5. Exposure to natural sources shall normally be considered as a chronic exposure situation and f necessaryi , , shal subjece requiremente b l th o t t r intersfo - vention, except that3: (a) public exposure delivered by effluent discharges or the disposal of radioactive waste arising fro mpractica e involving natural sources shal subjece e b l th o t t requirements for practices given here, unless the exposure is excluded or the practice or the source is exempted; and (b) occupational exposure of workers to natural sources shall be subject to the requirements for practices given in this section if these sources lead to: (i) exposure to radon required by or directly related to their work, irrespec- tive of whether the exposure is higher or lower than the action level for remedial action relatin chronio gt c exposure situations involving radon in workplaces4, unless the exposure is excluded or the practice or the source is exempted; or (ii) exposure to radon incidental to their work, but the exposure is higher than the action level for remedial action relating to chronic exposure situations involving radon in workplaces4; unless the exposure is exclude practice source th r th d o r exempteds eo ei r o ; (iii) exposure specifie e Regulatorth y b d y Authorit e subjecb o yt o suc t t h requirements. detailee Th 2.6d . requirement occupationar sfo l exposures, medical exposures, public exposure potentiad an s l exposure e specifiear s n Appendicei dI II , II , I s anrespectivelyV dI . These shal consideree b l d consequential requirements subsidi- ar thoso yt e establishe thin di s Section, unless other more desirable option pror sfo - tectio safetd nestablishee an yar Regulatore th y db y Authorit , wheryor e applicable, by the relevant Sponsoring Organization.

endorsemene time th th f eo t Standardse A th 3 f o t available th , e quantitative recom- mendations of the ICRP for protection against exposure to natural sources were confined to radontherefors wa t I . e decided thaGenerae th t l Obligation practicer sfo s concerning protec- tion against natural sources will be that exposure to natural sources, which is normally a chronic exposure situation, shoul subjece db interventioo t t thad requiremente nan th t r fo s practices should be generally limited to exposure to radon, the exposure to other natural sources being expected to be dealt with by exclusion or exemption of the source or otherwise at the discretion of the Regulatory Authority. e SchedulSe 4 , GuidelineVI e r Actiofo s n Level Chronin i s c Exposure Situations, para. VI-3. 2. REQUIREMENTS FOR PRACTICES 19

BASIC OBLIGATIONS

General obligations

2.7. No practice shall be adopted, introduced, conducted, discontinued or ceased and no source within a practice shall, as applicable, be mined, milled, processed, designed, manufactured, constructed, assembled, acquired, imported, exported, dis- tributed, sold, loaned, hired, received, sited, located, commissioned, possessed, used, operated, maintained, repaired, transferred, decommissioned, disassembled, transported, stored or disposed of, except in accordance with the appropriate require- mentStandardse th f so , unles exposure sth e from such practic sourcr eo excludes ei d fro Standarde mth practice th r s o r sourceo exemptes ei d fro requiremente mth f so e Standardsth , includin requiremente gth f notificatioo s authorizationd nan . applicatioe Th requirement2.8e th . f no Standarde th practicf y so y an an o st r eo sourc actione e th withi f o s y specifiepracticna an o t r paran eo d i shal 7 2. .come b l - mensurate with the characteristics of the practice or source and with the magnitude and likelihood of the exposures and shall also conform to any requirements specified by the Regulatory Authority or, whenever applicable, by the relevant Sponsoring Organizations. Not all the requirements are relevant for every practice or source, nor for all the actions specified in para. 2.7. 2.9. The transport of radioactive sources shall be subject to the requirements of e IAEth A Regulation e Safth er Transporfo s f Radioactivo t e Materialy an d an 5 applicable international convention.

ADMINISTRATIVE REQUIREMENTS

Notification legay An l2.10 perso. nactione intendinth f o s y specifie carran o gt t you d under Generae th l Obligation practicer sfo Standarde th f so s (se 2.8d e paraan ) shal7 s2. l submi notificatioa t Regulatore th o nt y Authorit f sucyo intentionn ha . Notification

for consumer product requires si d only with respec6 manufacturingo t , assembling, importing and distributing.

e mosth te recenSe 5 t editioe IAEth f Ao n Regulation e Safth er Transporfo s f o t Radioactive Material (publishe s IAEda A Safety Serie(1990)6 . No s ; 1996 editioe b o nt issued). 6 Notification alone is sufficient provided that the normal exposures associated with practice th r actioeo unlikele nar exceeo yt dsmala l fraction, specifie Regulatore th y b d y Authority relevane th f o , t limits, thad likelihooe an th t expected dan d amount f potentiao l exposur othey an rd detrimentaean l consequenc negligiblee ear . 20 PRINCIPAL REQUIREMENTS

Authorization: registration or licensing

e lega2.11Th l .perso n responsibl sealey an r d fo esource , unsealed sourcr o e radiation generator shall, unless the source is exempted, apply to the Regulatory Authority for an authorization which shall take the form of either a registration7 or a licence. legae 2.12Th l perso. n responsibl irradiatioy an r efo n installation, min r mileo l processing radioactive ores, installation processing radioactive substances, nuclear installation or radioactive waste management facility, or for any use of a source which the Regulatory Authority has not designated as suitable for registration, shall apply to the Regulatory Authority for an authorization which shall take the form of a licence. 2.13. Any legal person applying for an authorization shall: (a) submi Regulatore th o t y Authority and applicablef ,i relevane th , t Sponsoring Organization relevant information necessary to support the application; (b) refrain from carrying out any of the actions described in the General Obliga- tion practicer sfo Standarde th f so s (se 2.8ed paraan ) unti7 registratiose 2. th l n or licence, as appropriate, has been granted; (c) make an assessment of the nature, magnitude and likelihood of the exposures attributed to the source and take all necessary steps for the protection and safety of both workers and the public; and e potentia th n exposur a f i (dr )fo l s greatei e r thay levean n l specifiee th y b d Regulatory Authority, have a safety assessment made and submitted to the Regulatory Authorit applicatione s parth y a f o t . legae 2.14Th l perso. n responsibl sourca usee r medicar b e fo d fo o et l exposure shall includ e applicatioth n ei r authorizationnfo : (a) the qualifications in radiation protection of the medical practitioners who are to be so designated by name in the registration or licence; or (b) a statement that only medical practitioners with the qualifications in radiation protection specified in the relevant regulations or to be specified in the registra- tio r licencno e wil permittee b l prescribo dt e medical exposur meany eb f so the authorized source.

7 Typical practices that are amenable to registration are those for which: (a) safety largeln ca ensuree y desigb e facilitie e th th y f dnequipmentb o d an s operatine th ) (b ; g proce- dure simple sar followo safete t th ) y(c ;trainin g requirement minimale ) thersar (d s ed i an ; problema historw fe f o y s with safet operationsn i y . Registratio s besi n t suite thoso t d e practice r whicsfo h operation t varno y o significantlysd . 2. REQUIREMENTS FOR PRACTICES 21

Authorized legal persons: registrant licenseed san s

2.15. Registrants and licensees shall bear the responsibility for setting up and implementing the technical and organizational measures that are needed for ensuring protectio e source d safetth r nan r whic fo yfo s h thee authorizedar y . They ma y appoint other people to carry out actions and tasks related to these responsibilities, but they shall retain the responsibility for the actions and tasks themselves. Registrants and licensees shall specifically identify the individuals responsible for ensuring compliance with the Standards. 2.16. Registrant licenseed an s s shall notif e Regulatorth y y Authorit f theio y r intention introduco t s e modification practicy an o r t ssource o r whicefo h thee yar authorized, wheneve modificatione rth s could have significant implication pror sfo - tectio r safetyn o suc y shald t carran han ,t no lmodificatio you n unless specifically authorize Regulatore th y db y Authority.

Exemption

2.17. Practices and sources within a practice may be exempted from the require- Standarde mentth f o s s provided that such sources comply with: requiremente th (a) exemption so n specifie Scheduln di r o , eI (b) any exemption levels defined by the Regulatory Authority on the basis of the exemption criteria specifie Scheduln di . eI

2.18. Exemptio ngrantee b shal t practicer no ldfo sjustifiede b deeme o t t .dno

Clearance

2.19. Sources, including substances, material objectsd an s , within notifier o d authorized practice e releaseb y ma sd from further requirement e Standardth f o s s subject to complying with clearance levels approved by the Regulatory Authority. Such clearance levels shall take account of the exemption criteria specified in Schedule I and shall not be higher than the exemption levels specified in Schedule I r definee Regulatoro th y b d y Authorit e criteri e basith th f o sn a o y specifien i d Schedule I, unless otherwise approved by the Regulatory Authority8.

8 Clearance of bulk amounts of materials with activity concentrations lower than the guidance exemption levels specified in Table I-I of Schedule I may require further considera- tion by the Regulatory Authority. 2 2 PRINCIPAL REQUIREMENTS

RADIATION PROTECTION REQUIREMENTS

Justification of practices practico 2.20N r .sourc o e e withi practica n e shoul e authorizedb d unlese th s practice produces sufficient benefit to the exposed individuals or to society to offset the radiation harm tha t mighi t t cause; tha : unlesis t practice sth justifieds ei , taking into account social, economic and other relevant factors. 2.21. Detailed requirement justificatioe th r fo s f practiceo n s involving medical exposure givee ar s Appendin ni . xII

2.22. Excep justifier fo t d practices involving medical exposures e followinth , g practices are deemed to be not justified whenever they would result in an increase, by deliberate additio f radioactivo n e substance activationy b r o se activit th n i f , o y the associated commoditie r productso s :

(a) practices involving food, beverages, cosmetic othey an rr o scommodit r o y product intende r ingestiondfo , inhalatio r percutaneouno s intakr applio , e-by cation humaa , to n beingd an ; (b) practices involvin frivoloue gth f radiatio o e us s r radioactivno e substancen si commodities or products such as toys and personal jewellery or adornments.

Dose limitation e norma2.23Th l. exposur f individualeo s shal restrictee b l thao ds t neithee th r total effectiv totae th dos lr equivaleneno t dos relevano et t organ tissuesr so , caused by the possible combination of exposures from authorized practices, exceeds any relevant dose limit specifie Scheduln di , excepeII specian i t l circumstances provided foAppendin i r . DosxI e limits shal t applno l medicao yt l exposures from authorized practices.

Optimization of protection and safety

2.24. In relation to exposures from any particular source within a practice, except for therapeutic medical exposures, protectio safetd nan y shal optimizee b l orden di r that the magnitude of individual doses, the number of people exposed and the likeli- hood of incurring exposures all be kept as low as reasonably achievable, economic and social factors being taken into account, within the restriction that the doses to individuals delivered by the source be subject to dose constraints. procese 2.25Th f optimizatio.so f protectiono safetd nan y measure rangy sma e from intuitive qualitative analyse o quantitativt s e analyses using decision aiding . REQUIREMENT2 3 2 PRACTICER SFO S

techniques t shal bu e sufficien, b l o tak t l trelevan al e t factors into accouna n i t coherent way so as to contribute to achieving the following objectives: o determint (a) e optimized protectio d safetan n y measure e prevailinth r fo s g circumstances, with account taken of the available protection and safety option naturee s welth a s s a l , magnitud likelihood ean f exposuresdo d an ; (b) to establish criteria, on the basis of the results of the optimization, for the restriction of the magnitudes of exposures and of their probabilities by means of measures for preventing accidents and mitigating their consequences.

Dose constraints

2.26. Except for medical exposure, the optimization of the protection and safety measures associated witparticulay han r source withi npractica e shal subjece b l o t t dose constraints which: (a) do not exceed either the appropriate values established or agreed to by the Regulatory Authority for such a source or values which can cause the dose limits to be exceeded; and (b) y sourcensurean r efo , (including radioactive waste management facilities) that can release radioactive substances to the environment, that the cumulative effects of each annual release from the source be restricted so that the effective dose in any year to any member of the public, including people distant fro e sourcmth peopl d ean f futureo e generations s unlikeli , exceeo yt y dan relevant dose limit, taking into account cumulative releases and the exposures expecte e delivereb l otheo dt al y rdb relevant source practiced an s s under control.

Guidance levels for medical exposure

2.27. Guidance levels for medical exposure shall be established for use by medical practitioners. The guidance levels are intended: reasonabla e b o t (a)e indicatio f doseno r averagsfo e sized patients; (b) to be established by relevant professional bodies in consultation with the Regulatory Authority followin detailee gth d requirement f Appendiso d an I xI the guidance levels give Scheduln ni e III; (c) to provide guidance on what is achievable with current good practice rather tha whan no t shoul consideree db d optimum performance; appliee b o t (dd) with flexibility alloo t w higher exposure f thessi indicatee ear d by sound clinical judgement; and revisee b o t technologs da ) (e techniqued yan s improve. 24 PRINCIPAL REQUIREMENTS

MANAGEMENT REQUIREMENTS

Safety culture

2.28. A safety culture shall be fostered and maintained to encourage a questioning and learning attitud protectioo et discourago safetd t nd an yan e complacency, which shall ensure that: (a) policies and procedures be established that identify protection and safety as being of the highest priority; (b) problems affecting protection and safety be promptly identified and corrected in a manner commensurate with their importance; (c) the responsibilities of each individual, including those at senior management levels r protectiofo , safetd nan clearle b y y identifie eacd an dh individuae b l suitably trained and qualified; (d) clear lines of authority for decisions on protection and safety be defined; and (e) organizational arrangement d line f an scommunicationo s e effecteb s d that resulappropriatn a n i t e flo f informatiowo protection o n d safetd an nan t a y between the various levels in the organization of the registrant or licensee.

Quality assurance

2.29. Quality assurance programmes shall be established that provide, as appropriate: (a) adequate assurance thaspecifiee th t d requirements relatin protectioo gt d nan safety are satisfied; and (b) quality control mechanism procedured an s r reviewinfo s assessind gan e gth overall effectiveness of protection and safety measures.

Human factors

2.30. Provision shall be made for reducing as far as practicable the contribution of human error to accidents and other events that could give rise to exposures, by ensuring that: (a) all personnel on whom protection and safety depend be appropriately trained and qualified so that they understand their responsibilities and perform their duties with appropriate judgement and according to defined procedures; (b) sound ergonomic principles be followed as appropriate in designing equipment and operating procedures facilitato t s a safe o s ,e th e operatioequipf o e us - r no ment minimizo t , possibilite eth y that operating errors will lea accidentso dt , and to reduce the possibility of misinterpreting indications of normal and abnormal conditionsd an ; . REQUIREMENT2 5 2 PRACTICER SFO S

(c) appropriate equipment, safety systems, and procedural requirements be provided and other necessary provisions be made: practicable s reduceo a t r (ifa ) s a , possibilite th , y that human error will lead to inadvertent or unintentional exposure of any person; (ii) to provide means for detecting human errors and for correcting or compensating for them; and (iii) to facilitate intervention in the event of failure of safety systems or of other protective measures.

Qualified experts

2.31. Qualified experts shall be identified and made available for providing advice on the observance of the Standards. 2.32. Registrants and licensees shall inform the Regulatory Authority of their arrangement mako t s e availabl expertise eth e necessar provido yt e e advicth n eo observanc Standardse th f eo informatioe Th . n provided shall includ scope e eth th f eo function qualifiey an f o s d experts identified.

TECHNICAL REQUIREMENTS

2.33. Relevant principal parties shall ensure thaprotectioe th t safetd nan y mea- sures for practices and sources for which they have responsibilities, other than nuclear installations and radioactive waste management facilities, are governed by the interrelated technical requirement paraf so s 2.34-2.36. These technical require- ments shal appliee b l d when appropriat extenn a o t t d commensuratean e wite hth magnitud likelihood ean exposuree th f do s expected fro practice mth r sourceeo . Nuclear installations and radioactive waste management facilities, including disposal facilities, are typically subject to more specific technical and other requirements such s thosa e issued unde IAEA'e th r s Nuclear Safety Standards (NUSS) Programme 9

and Radioactive Waste Safety Standards (RADWASS) Programme, as well as 0

other relevant requirement Sponsorine th f so g Organizations thess A . e more specifi1 c requirement generalle sar y consistent wit Standardse hth t followi , s that complyn i , - ing with them, such more complex installations should also generally comply with the Standards.

9 Publications withi IAEA'e nth s NUSS Programme, Safety. Serie50 . sNo 10 Publications withi IAEA'e nth s RADWASS Programme, Safety Serie . 111sNo . 26 PRINCIPAL REQUIREMENTS

Securit f sourceyo s

2.34. Sources shal kepe b l tpreven o t secur s a o ets thef damagr o tpreveno t d ean t any unauthorized legal person from carrying out any of the actions specified in the General Obligations for practices of the Standards (see paras 2.7-2.9), by ensuring that: (a) control of a source not be relinquished without compliance with all relevant requirements specified in the registration or licence and without immediate communication to the Regulatory Authority, and when applicable to the rele- vant Sponsoring Organization informatiof o , n regardin decontrolledy gan , lost, stole r missinno g source; (b) a source not be transferred unless the receiver possesses a valid authorization; and periodia (c) c inventor f movablyo e source conductee sb t appropriatda e intervals to confirm that they are in their assigned locations and are secure.

Defence in depth

2.35. A multilayer (defence in depth) system of provisions for protection and safety commensurate with the magnitude and likelihood of the potential exposures involved shal appliee b l sourceo dt s such tha failura layee t on compensate s t i r ea d for or corrected by subsequent layers, for the purposes of: (a) preventing accidents causy thama t e exposure; (b) mitigatin consequencee gth sucy an h f accidenso t that does occurd an ; (c) restoring sources to safe conditions after any such accident.

Good engineering practice applicables A 2.36. sitinge th , , location, design, construction, assembly, commis- sioning, operation, maintenance and decommissioning of sources within practices shal basee b l sounn do d engineering which shall s appropriatea , : (a) take account of approved codes and standards and other appropriately documented instruments; (b) be supported by reliable managerial and organizational features, with the aim of ensuring protection and safety throughout the life of the sources; (c) include sufficient safety margin desige th constructio d r nsan fo sourcese th f no , anr operationfo d s involvin e sourcesgth , ensuro suct s a h e reliable perfor- mance during normal operation, taking into account quality, redundancy and inspectability, with emphasi preventinn so g accidents, mitigating their conse- quences and restricting any future exposures; and 2. REQUIREMENTS FOR PRACTICES 27

(d) take accoun f relevano t t development technican i s l criteriae th s wela ,s a l results of any relevant research on protection or safety and lessons from experience.

VERIFICATION OF SAFETY

Safety assessments

2.37. Safety assessments relate protectioo dt safetd nan y measure r sourcefo s s within practices shall be made at different stages, including siting, design, manu- facture, construction, assembly, commissioning, operation, maintenance and decom- missioning appropriates a , ordern i , : (a) to identify the ways in which normal exposures and potential exposures coul incurrede db , account being effece taketh f eventf o nto s externae th o t l source s wela sevents a l s directly involvin sourcee gth theid san r associated equipment; determino t (b) expectee eth d magnitude f normaso l exposures extene andth o ,t t reasonable and practicable, to estimate the probabilities and the magnitudes of potential exposures; and asseso t (c qualite ) sth extenprotectioe d th yan f o t safetd nan y provisions.

Monitorin verificatiod gan f compliancno e

2.38. Monitorin measurementd gan s shal conductee b l parametere th f do s neces- sary for verification of compliance with the requirements of the Standards. 2.39. For the purposes of monitoring and verification of compliance, suitable equipment shall be provided and verification procedures introduced. The equipment shal properle b l y maintaine tested shald an calibratede an b l t appropriatda e inter- vals with referenc standardo et s traceabl nationao et r internationao l l standards.

Records

2.40. Records shal maintainee b l resulte th f monitorindf o so verificatiod gan f no compliance, including records of the tests and calibrations carried out in accordance with the Standards. 3. REQUIREMENTS FOR INTERVENTION

APPLICATION

3.1. The intervention situations to which the Standards apply are:

(a) emergency exposure situations requiring protective actio reduco nt r avereo t temporary exposures, including: (i) accident emergencied an s whicn i s emergencn ha y pla r emergencno y procedures have been activated; and y othean (iir) temporary exposure situation identifie e Regulatorth y b d y Authority or the Intervening Organization as warranting intervention; and (b) chronic exposure situations requiring remedial action to reduce or avert chronic exposure, including: (i) natural exposure, suc exposurs ha radoo et buildingn i workplacesd san ; (ii) exposur radioactivo et e residues from past events radioe th , o suct - s ha active contamination caused by accidents, after the situation requiring protective action has been terminated, as well as from the conduct of f sourceo e t undepracticeus sno e systee th rth d f notificationmsan o d an , authorizationd an ; y othe(iiian )r chronic exposure situation specifiee Regulatorth y b d y Authorit Intervenine th r yo g Organizatio s warrantinna g intervention. 3.2. The detailed requirements relating to emergency exposure situations and chronic exposur Appendicen i e I respectivelyt situationV ou d t an se e sV sar . These shal consideree b l consequentias da l requirements subsidiar thoso yt e specifie thin di s Section, unless other more desirable options for protection and safety are established by the Regulatory Authority or, where applicable, by a relevant Sponsoring Organization.

BASIC OBLIGATIONS

3.3. In order to reduce or avert exposures in intervention situations, protective actions or remedial actions shall be undertaken whenever they are justified. 3.4. The form, scale, and duration of any such protective action or remedial action shall be optimized so as to produce the maximum net benefit, understood in broaa d sense, unde prevailine th r g socia economid an l c circumstances.

28 . REQUIREMENT3 9 2 INTERVENTIOR SFO N e cas th f emergenc eo n I 3.5. y exposure situations, protective t actionno e ar s normally likely to be necessary unless intervention levels or action levels11 are or may be exceeded. 3.6. In the case of chronic exposure situations, remedial actions are not normally

likelnecessare b o yt y unles relevane sth t action levels exceedede ar .

1 1

ADMINISTRATIVE REQUIREMENTS

Responsibilities

3.7. For occupational exposures incurred by workers undertaking intervention, responsibilitiee th t fort sse Appendi n hi shalxV dischargee b l registrane th y db r o t licensee, the employer and the Intervening Organizations, as required by the Regula- tory Authority. publir Fo c3.8 exposur. intervention ei n situations, responsibilities identified dan assigned by the government for the various organizational arrangements and functions necessar r ensurinyfo g effective intervention shal dischargede b l : (a) by the appropriate national, regional or local Intervening Organizations; and, a practic f i r sourco ) e (b e tha s registerei t r licenseo d s involvedi d e th y b , registran r licenseeo t . 3.9. Each registrant r licenseo e responsibl r sourceefo whicr sfo h prompt inter- vention may be required shall ensure that an emergency plan exists that defines on- site responsibilities and takes account of off-site responsibilities appropriate for the source and provides for implementation of each relevant form of protective action, as set out in Appendix V. 3.10. The relevant Intervening Organizations shall prepare a general plan or plans for co-ordinating and implementing the actions required for supporting protective actions under the emergency plans of registrants and licensees, as well as for other situations that may require prompt intervention. This includes situations involving such sources of exposure as sources illegally brought into the country, falling satel- lites equipped with sources or radioactive materials released in accidents beyond national borders.

11 Intervention level actiod san n levels serv proteco et t membere publie ar th d f sco an specified separately for different protective actions and remedial actions. Optimized levels for justified intervention normalle ar s y selecte r inclusiodfo emergencn ni y plan remediad san l action plans, and, in the case of accidents, are re-evaluated at the time of their implementation on the basis of current conditions. 30 PRINCIPAL REQUIREMENTS

3.11. For chronic exposure situations in which the relevant action levels for remedia exceedede b y lma relevane actionr th ,o e ar st Intervening Organizations shall ensure that generi r sito c e specific remedial action plans s necessarya , e ar , developed. When remedial action is to be undertaken, the legal person responsible for carryin remediae th t gou l action shall ensur accordancn i e s thai t i t e wite hth generic remedial action pla r thano t specific remedial action plan developede ar s , approve implementedd dan .

Notification requirements

3.12. Registrants and licensees shall notify the Regulatory Authority and the rele- vant Intervening Organizations promptly when a situation requiring protective action has arisen or is expected to arise, and shall keep them informed of: (a) the situation as it develops and how it is expected to develop; (b) the measures taken for the protection of workers and members of the public; and (c) the exposures that have been incurred and that are expected to be incurred.

RADIATION PROTECTION REQUIREMENTS

3.13. Interventio justifies ni s dexpectei t onli f yi achievo dt e more good than harm, wite regarhdu healtho dt , socia economid an l c factors dose th ef I .level s approac expectee ar r ho approaco dt levele hth s specifie Scheduln di , protectiveIV e actions or remedial actions will be justified under almost any circumstances. 3.14. Optimized intervention level actiod san n levels shal specifiee b l plann di s for intervention situations, on the basis of the guidelines given in Schedules V and , modifieVI tako dt e accoun f loca o nationatd an l l conditions, suc: has (a) the individual and collective exposures to be averted by the intervention; and radiologicae th (b) non-radiologicad an l l healt financiae h th risk d sociad san an l l cost benefitd an s s associated wit interventione hth . 3.15. Durin response gth accidentn a o et , justificatio interventiof no optimid nan - zation of pre-established intervention levels shall be reconsidered, with account take: nof (a) those factors which are unique to the actual situation, such as the nature of the release, weather conditions and other relevant non-radiological factors; and (b) the likelihood that the protective actions will provide a net benefit, given that future conditions may be uncertain.