EN ISO 17099-2017 Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymp.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO 17099:2014)BS EN ISO 17099:2017EUROPEAN

2、 STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17099 October 2017 ICS 13.280 English Version Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO 17099:2014) Radioprotecti

3、on - Critres de performance pour les laboratoires pratiquant la dosimtrie biologique par le test des micronoyaux avec blocage de la cytodirse (CBMN) dans les lymphocytes du sang priphrique (ISO 17099:2014) This European Standard was approved by CEN on 13 September 2017. CEN members are bound to comp

4、ly 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 lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

5、 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 under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the sa

6、me status as the 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

7、, Malta, Netherlands, 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 Bru

8、ssels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17099:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 17099:2017. It is identical to ISO 17099:2014.The UK participation in its preparat

9、ion was entrusted to Technical Committee NCE/2, Radiation protection and measurement.A list of organizations represented on this 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 it

10、s correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 96932 4ICS 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 S

11、trategy Committee on 31 January 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 17099:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17099 October 2017 ICS 13.280 English Version Radiological protection - Performance criteria for laborator

12、ies using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO 17099:2014) Radioprotection - Critres de performance pour les laboratoires pratiquant la dosimtrie biologique par le test des micronoyaux avec blocage de la cytodirse (CBMN) dans l

13、es lymphocytes du sang priphrique (ISO 17099:2014) 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

14、 alteration. Up-to-date lists 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 languag

15、e 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 official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,

16、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, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMIT

17、TEE FOR STANDARDIZATION COMIT 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 17099:2017 EBS EN ISO 1

18、7099:2017EN ISO 17099:2017 (E) 3 European foreword The text of ISO 17099:2014 has been prepared by Technical Committee ISO/TC 85 “Nuclear energy, nuclear technologies, and radiological protection” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 17099:201

19、7 by Technical Committee CEN/TC 430 “Nuclear energy, nuclear technologies, and radiological protection” the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by A

20、pril 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 this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. Accordi

21、ng to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, G

22、reece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 17099:2014 has been approved by CEN as EN ISO 17099

23、:2017 without any modification. BS EN ISO 17099:2017ISO 17099:2014(E)Contents PageForeword vIntroduction vi1 Scope . 12 Terms and definitions . 13 Micronucleus assay methodology used in this standard 43.1 General . 43.2 General requirement of the laboratory 43.3 Requests for analysis and blood sampl

24、ing 43.4 Cell culturing . 53.5 Staining 53.6 Microscopy . 63.7 Visual scoring of slides . 63.8 Automated analysis . 74 Confidentiality of personal information 74.1 Overview 74.2 Applications of the principle of confidentiality 75 Laboratory safety requirements 85.1 Overview 85.2 Microbiological safe

25、ty requirements . 85.3 Chemical safety requirements . 95.4 Optical safety requirements . 105.5 Safety plan 106 Calibration source(s), calibration curve, and minimum resolvable dose 106.1 Calibration source(s) 106.2 Calibration curve 106.3 Background micronucleus frequency 116.4 Minimum resolvable do

26、se measurement 127 Responsibility of the customer .128 Responsibility of the CBMN laboratory 128.1 Setup and sustainment of the QA program 128.2 Responsibility during service 139 Accidental overexposure involving few individuals .149.1 Procedure for scoring micronuclei in binucleated cells .149.2 Cr

27、iteria for converting a micronucleus yield into an estimate of absorbed dose .149.3 Reporting of Results 1510 Population triage 1710.1 General 1710.2 Use of a CBMN assay network for large scale exposures .1710.3 Procedure for scoring micronuclei in binucleated cells .1710.4 Criteria for converting a

28、 micronucleus yield into an estimate of absorbed dose .1710.5 Reporting of results . 1711 Quality assurance and quality control 1711.1 Overview . 1711.2 Quality Assurance 1711.3 Quality control 18Annex A (informative) Sample data sheet for recording micronuclei in binucleated cells 20Annex B (inform

29、ative) Automation of micronuclei scoring .21Annex C (informative) Instructions for customer (sample) 23 ISO 2014 All rights reserved iiiBS EN ISO 17099:2017ISO 17099:2014(E)Annex D (informative) Sample questionnaire .24Annex E (informative) Sample of report for single assessment 26Annex F (informati

30、ve) Example group sample report .27Bibliography .29iv ISO 2014 All rights reservedBS EN ISO 17099:2017ISO 17099:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Stan

31、dards 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, also t

32、ake 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. In p

33、articular 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 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements o

34、f 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 (see

35、 www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to

36、 the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword Supplementary information .The committee responsible for this document is ISO/TC 85, Nuclear energy, nuclear technologies, and radiological protection, Subcommittee SC 2, Radiological protection. ISO 2014 A

37、ll rights reserved vBS EN ISO 17099:2017ISO 17099:2014(E)IntroductionThe purpose of this International Standard is to define the use of the cytokinesis block micronucleus (CBMN) assay with human peripheral blood lymphocytes for biological dosimetry of exposure to ionizing radiation. This assay is in

38、tended to be applied for accidental or malevolent exposures involving a) up to a few casualties to provide individual full dose estimates or b) in a triage mode to populations to provide interim dose estimates for individuals.The CBMN assay is an alternative cytogenetic technique, which is possibly

39、simpler and faster to perform than the dicentric assay (ISO 19238:2014, ISO 21243:2008). It is also routinely used to demonstrate exposure to genotoxic agents, other than ionizing radiation, which is not covered in this International Standard. Although culture of the blood samples is slightly longer

40、 than for dicentrics, the scoring of micronuclei in binucleated lymphocytes is easier.As was done with the dicentric assay, the CBMN assay has been adapted for the emergency triage of large-scale multi casualty radiation accidents. The blood volume required for sufficient number of scorable binuclea

41、ted cells is similar than required for the dicentric assay. Again, the faster counting speed for micronuclei compensates for the extended culture time. In addition, the CBMN assay can be performed in an automated mode.This International Standard provides a guideline on how to perform the CBMN assay

42、for dose assessment using documented and validated procedures. Dose assessment using the CBMN assay has relevance in medical management, radiation-protection management, record keeping, and medical/legal requirements. This International Standard is divided into two parts, according to the use of CBM

43、N assay: radiation exposure of a few individuals or population triage in a large radiological event.A part of the information in this International Standard is contained in other international guidelines and scientific publications, primarily in the International Atomic Energy Agencys (IAEA) technic

44、al reports series on biological dosimetry. However, this International Standard expands and standardizes the quality assurance and quality control, the criteria of accreditation and the evaluation of performance. This International Standard is generally compliant with ISO/IEC 17025 “General requirem

45、ents for the competence of testing and calibration laboratories” with particular consideration given to the specific needs of biological dosimetry. The expression of uncertainties in dose estimations given in this International Standard complies with the “ISO-guide for the expression of uncertainty

46、in measurement” (former GUM) and the ISO 5725-all parts.vi ISO 2014 All rights reservedBS EN ISO 17099:2017Radiological protection Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry1 ScopeThis Internati

47、onal Standard addresses the following:a) confidentiality of personal information for the customer and the laboratory;b) laboratory safety requirements;c) radiation sources, dose rates, and ranges used for establishing the calibration reference dose-effect curves allowing the dose estimation from CBM

48、N assay yields and the minimum resolvable dose;d) performance of blood collection, culturing, harvesting, and sample preparation for CBMN assay scoring;e) scoring criteria;f) conversion of micronucleus frequency in binucleated cells into an estimate of absorbed dose;g) reporting of results;h) qualit

49、y assurance and quality control;i) informative annexes containing examples of a questionnaire, instructions for customers, a microscope scoring data sheet, a sample report and advice on strengths and limitations of current automated systems for automated micronucleus scoring.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1acentricchromosome fragment of varying sizeNote 1 to entry: When it is formed independently of a dicentric or centric ring chromosome aberration, it is usually referred t