EN ISO 19238-2017 en Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Radiological protection Performance criteria for service laboratories performing biological dosimetry by cytogenetics (ISO 19238:2014)BS EN ISO 19238:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 19238 Oc

2、tober 2017 ICS 13.280; 17.240 English Version Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics (ISO 19238:2014) Radioprotection - Critres de performance pour les laboratoires de service pratiquant la dosimtrie biologique par cyto

3、gntique (ISO 19238:2014) This European Standard was approved by CEN on 13 September 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date li

4、sts and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation unde

5、r the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Y

6、ugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION CO

7、MIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 19238:2017 ENational forewordThis British Standar

8、d is the UK implementation of EN ISO 19238:2017. It is identical to ISO 19238:2014. It supersedes BS ISO 19238:2014, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee NCE/2, Radiation protection and measurement.A list of organizations represented on this

9、 committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 96928 7ICS 1

10、7.240; 13.280Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2018.Amendments/corrigenda issued since publicationDate Text affected31 January 2018 This

11、 corrigendum renumbers BS ISO 19238:2014 as BS EN ISO 19238:2017BRITISH STANDARDBS EN ISO 19238:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 19238 October 2017 ICS 13.280; 17.240 English Version Radiological protection - Performance criteria for service laboratories performing biolog

12、ical dosimetry by cytogenetics (ISO 19238:2014) Radioprotection - Critres de performance pour les laboratoires de service pratiquant la dosimtrie biologique par cytogntique (ISO 19238:2014) This European Standard was approved by CEN on 13 September 2017. CEN members are bound to comply with the CEN/

13、CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Cent

14、re or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the

15、 official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherl

16、ands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN A

17、ll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 19238:2017 EBS EN ISO 19238:2017EN ISO 19238:2017 (E) 3 European foreword The text of ISO 19238:2014 has been prepared by Technical Committee ISO/TC 85 “Nuclear energy, nuclear technol

18、ogies, and radiological protection” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 19238:2017 by Technical Committee CEN/TC 430 “Nuclear energy, nuclear technologies, and radiological protection” the secretariat of which is held by AFNOR. This European

19、Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2018, and conflicting national standards shall be withdrawn at the latest by April 2018. Attention is drawn to the possibility that some of the elements of

20、this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austri

21、a, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain,

22、 Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 19238:2014 has been approved by CEN as EN ISO 19238:2017 without any modification. BS EN ISO 19238:2017ISO 19238:2014(E) ISO 2014 All rights reserved iiiContents PageForeword vIntroduction vi1 Scope . 12 Terms an

23、d definitions . 13 Dicentric assay 34 Responsibility of the customer 35 Responsibility of the service laboratory 45.1 Setup and sustainment of the QA program . 45.2 Responsibility during service . 46 Confidentiality of personal information 56.1 Overview 56.2 Applications of the principle of confiden

24、tiality 57 Laboratory safety requirements 67.1 Overview 67.2 Microbiological safety requirements . 67.3 Chemical safety . 67.4 Optical safety requirements 87.5 Safety plan . 88 Calibration curve(s) 98.1 Culturing . 98.2 Calibration source(s) 108.3 Establishment of calibration curve(s) . 108.4 Minimu

25、m resolvable dose measurement 119 Scoring unstable chromosome aberrations 119.1 Procedure for scoring first-division metaphases .119.2 Criteria for scoring 1110 Criteria for converting a measured aberration frequency into an estimate of absorbed dose 1210.1 Overview . 1210.2 Comparison with controls

26、 1210.3 Testing the distribution of aberrations per cell .1210.4 Determination of estimated whole-body dose and confidence limits .1210.5 Acute and non-acute exposure cases 1310.6 Partial-body and prior-exposure cases . 1311 Reporting of results 1511.1 General 1511.2 Content of the report (see Annex

27、 C for a standard form) .1511.3 Interpretation of the results .1612 Quality assurance and quality control 1612.1 Overview .1612.2 Specific requirements 17Annex A (informative) Sample instructions for customer 19Annex B (informative) Sample questionnaire .20Annex C (informative) Sample of report 22An

28、nex D (informative) Fitting of the low-LET dose-response curve by the method of maximum likelihood and calculating the error of dose estimate .23Annex E (informative) Odds ratio method for cases of suspected exposure to a low dose .26BS EN ISO 19238:2017ISO 19238:2014(E)iv ISO 2014 All rights reserv

29、edAnnex F (informative) Sample data sheet for recording aberrations .27Bibliography .28BS EN ISO 19238:2017ISO 19238:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International

30、 Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, a

31、lso take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1.

32、 In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention is drawn to the possibility that some of the elements of

33、 this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.

34、iso.org/patentsAny trade name used in this document is information given for the convenience of users and does not constitute an endorsement.The committee responsible for this document is ISO/TC 85, Nuclear energy, nuclear technologies, and radiological protection, Subcommittee SC 2, Radiological pr

35、otection.This second edition cancels and replaces the first edition (ISO 19238:2004), of which it constitutes a minor revision. ISO 2014 All rights reserved vBS EN ISO 19238:2017ISO 19238:2014(E)IntroductionThe wide use of ionising radiations for medical, industrial, agricultural, research, and mili

36、tary purposes increases the risk of overexposure of radiation workers and individuals of the general population. Biological dosimetry, based on the study of chromosomal aberrations, mainly the dicentric assay, has become a routine component of accidental dose assessment. Experience with its applicat

37、ion in hundreds of cases of suspected or verified overexposures has proved the value of this method and also defined its limitations. It should be emphasized that cytogenetic analysis is used as a dosimeter and provides one input into the compendium of information needed for assessment of a radiolog

38、ical accident.Many studies in animals and man have shown that one can establish a good correlation between the results obtained in vivo and in vitro, so that in vitro established dose-effect relationships from irradiated blood samples can be used as calibration curves. The dicentric yield is depende

39、nt on radiation quality and dose rate so that information about these variables needs to be established for each investigation. If known, these exposure characteristics are important for refining the dose estimates. The specificity of this technique is enhanced by the fact that generally 1 dicentric

40、 is observed per 1 000 metaphase spreads in the normal population, and that this frequency is approximatively independent of age and sex. The precision of the technique thus depends on the number of cells observed, the background level, and the calibration curve used. Theoretically, it is possible t

41、o detect exposure as low as 0,01 Gy. However, for these very low doses, it is necessary to analyse tens of thousands of metaphase spreads. In practice, this level of detection is neither feasible nor necessary. The upper limits to dose detection extend well into the range of doses that are lethal to

42、 humans.The primary purpose of this International Standard is to provide a guideline to all laboratories in order to perform the dicentric assay using documented and validated procedures. Secondly, it can facilitate the comparison of results obtained in different laboratories, particularly for inter

43、national collaborations or intercomparisons. Finally, laboratories newly commissioned to carry out the dicentric assay should conform to this International Standard in order to perform it reproducibly and accurately.This International Standard is written in the form of procedures to be adopted for b

44、iological dosimetry for overexposures involving, at most, a few casualties. The criteria required for such measurements will usually depend upon the application of the results: radiation protection management, medical management when appropriate, record keeping, and legal requirements. In the specia

45、l situation of a mass radiation casualty and limited resources, the technique can be applied for emergency triage analysis. The standard recommended scoring criteria would then be relaxed as appropriate to the situation.A part of the information in this International Standard is contained in other i

46、nternational guidelines and scientific publications, primarily in the International Atomic Energy Agencys (IAEA) Technical Reports Series on Biological Dosimetry. However, this International Standard expands and standardizes the quality assurance and quality control, the criteria of accreditation, a

47、nd the evaluation of performance. This International Standard is generally compliant with ISO/IEC 17025, with particular consideration given to the specific needs of biological dosimetry. The expression of uncertainties in dose estimations given in this International Standard comply with the ISO gui

48、de to the expression of uncertainty in measurement (ISO/IEC Guide 98-1) and the ISO 5725 on accuracy (trueness and precision) of measurement methods and results.vi ISO 2014 All rights reservedBS EN ISO 19238:2017Radiological protection Performance criteria for service laboratories performing biologi

49、cal dosimetry by cytogenetics1 ScopeThis International Standard provides criteria for quality assurance and quality control, evaluation of the performance, and the accreditation of biological dosimetry by cytogenetic service laboratories.This International Standard addressesa) the confidentiality of personal information, for the customer and the service laboratory,b) the laboratory safety requirements,c) the calibration sources and calibration dose ranges useful for establishing the reference dose-effect curves that contribute to the dose estimatio