1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11137-2:2013Sterilization of health care products RadiationPart 2: Establishing the sterilization doseCopyright European Committee for Standardization Provided by IHS u
2、nder license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11137-2:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11137-2:2013. It supersedes BS EN ISO 11137-2:2012 which iswithdrawn.The UK particip
3、ation in its preparation was entrusted to TechnicalCommittee CH/198, Sterilization of medical devices.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are res
4、ponsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 79909 9ICS 11.080.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandard
5、s Policy and Strategy Committee on 30 June 2013.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROP
6、ENNE EUROPISCHE NORM EN ISO 11137-2 June 2013 ICS 11.080.01 Supersedes EN ISO 11137-2:2012English Version Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) Strilisation des produits de sant - Irradiation - Partie 2: tablissement de la
7、dose strilisante (ISO 11137-2:2013)Sterilisation von Produkten fr die Gesundheitsfrsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO 11137-2:2013) This European Standard was approved by CEN on 25 May 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations whi
8、ch 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 Centre or to any CEN member. This Eu
9、ropean 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 official versions. CEN members
10、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, Netherlands, Norway, Poland, Portugal,
11、Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any mea
12、ns reserved worldwide for CEN national Members. Ref. No. EN ISO 11137-2:2013: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11137-2:2013EN ISO 11137-2:2013 (E) 3 For
13、eword This document (EN ISO 11137-2:2013) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of which is held by BSI. This European Standard shall be given
14、 the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2013, and conflicting national standards shall be withdrawn at the latest by December 2013. Attention is drawn to the possibility that some of the elements of this document may
15、 be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11137-2:2012. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associat
16、ion, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annex ZA, B and C, which are integral parts of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound t
17、o implement this European Standard: 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, Netherlands, Norway, Poland, Portugal, R
18、omania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11137-2:2013 has been approved by CEN as EN ISO 11137-2:2013 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot
19、for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11137-2:2013EN ISO 11137-2:2013 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices This Europ
20、ean Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices. Once this standard is cited in the
21、 Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the c
22、orresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 90/385/EEC Clauses of this European Standard Essential Requirements (ERs) of EU Directive 90/385/EEC Qualifying remarks/Notes 4, 5, 6, 7, 8, 9
23、, 10 7 This relevant ER is only partly addressed in this International Standard and only in conjunction with ISO 11137-1. Packaging for maintenance of sterility during transportation and storage are not covered. WARNING Other requirements and other EU Directives may be applicable to the product(s) f
24、alling within the scope of this standard. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11137-2:2013EN ISO 11137-2:2013 (E) 5 Annex ZB (informative) Relationship betw
25、een this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements o
26、f the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZB.1 con
27、fers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZB.1 Correspondence between this European Standard and EU Directive 93/42/EEC Clauses of this European Standard Es
28、sential Requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 4, 5, 6, 7, 8, 9, 10 8.3 This relevant ER is only partly addressed in this International Standard and only in conjunction with ISO 11137-1. Packaging for maintenance of sterility during transportation and storage are not c
29、overed. 4, 5, 6, 7, 8, 9, 10 8.4 This relevant ER is addressed in this International Standard only in conjunction with ISO 11137-1. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Copyright European Committee for Stand
30、ardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11137-2:2013EN ISO 11137-2:2013 (E) 6 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/
31、EC on in vitro diagnostic medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 98/79/EC on in vitro diagnostic
32、medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZC.1 confers, within the limits of the scope of th
33、is standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZC.1 Correspondence between this European Standard and Directive 98/79/EC Clauses of this European Standard Essential Requirements (ERs) of EU Directive 98/
34、79/EC Qualifying remarks/Notes 4, 5, 6, 7, 8, 9, 10 B.2.3 This relevant ER is only partly addressed in this International Standard and only in conjunction with ISO 11137-1. Packaging for maintenance of sterility during transportation and storage are not covered. 4, 5, 6, 7, 8, 9, 10 B.2.4 This relev
35、ant ER is only addressed in this International Standard in conjunction with ISO 11137-1. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Copyright European Committee for Standardization Provided by IHS under license wi
36、th CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11137-2:2013ISO 11137-2:2013(E) ISO 2013 All rights reserved iiiContents PageForeword vIntroduction vi1 Scope . 12 Normative references 13 Terms, definitions, and abbreviated terms . 13.1 Terms and def
37、initions . 13.2 Abbreviated terms . 34 Definition and maintenance of product families for dose setting, dose substantiation, and sterilization dose auditing . 44.1 General . 44.2 Defining product families 44.3 Designation of product to represent a product family for performance of a verification dos
38、e experiment or sterilization dose audit 54.4 Maintaining product families . 64.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a product family 75 Selection and testing of product for establishing the sterilization dose . 75.1 Nature of product . 75.2
39、Sample item portion (SIP) . 85.3 Manner of sampling 95.4 Microbiological testing . 95.5 Irradiation . 96 Methods of dose establishment 97 Method 1: dose setting using bioburden information 107.1 Rationale 107.2 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0
40、 for multiple production batches 117.3 Procedure for Method 1 for product with an average bioburden greater than or equal to 1,0 for a single production batch . 177.4 Procedure for Method 1 for product with an average bioburden in the range 0,1 to 0,9 for multiple or single production batches . 198
41、Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor .208.1 Rationale 208.2 Procedure for Method 2A 218.3 Procedure for Method 2B 249 Method VDmax Substantiation of 25 kGy or 15 kGy as the sterilization dose .289.1 Rationale 289.2 Pr
42、ocedure for Method VDmax25for multiple production batches .299.3 Procedure for Method VDmax25for a single production batch .349.4 Procedure for Method VDmax15for multiple production batches .379.5 Procedure for Method VDmax15for a single production batch .4010 Sterilization dose audit .4310.1 Purpos
43、e and frequency . 4310.2 Procedure for auditing a sterilization dose established using Method 1, Method 2A, or Method 2B 4310.3 Procedure for auditing a sterilization dose substantiated using Method VDmax25or Method VDmax154610.4 Failure of a sterilization dose audit 5211 Worked examples .52Copyrigh
44、t European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11137-2:2013ISO 11137-2:2013(E)iv ISO 2013 All rights reserved11.1 Worked examples for Method 1 5211.2 Worked examples for Metho
45、d 2 5411.3 Worked examples for Method VDmax.6211.4 Worked example of a sterilization dose audit for a dose established using Method 1, the findings from which necessitated augmentation of the sterilization dose 6411.5 Worked example of a sterilization dose audit for a dose established using Method 2
46、A, the findings from which necessitated augmentation of the sterilization dose 6411.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using Method VDmax2565Bibliography .67Copyright European Committee for Standardization Provided by IHS under license with CENNot f
47、or ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11137-2:2013ISO 11137-2:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Stan
48、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 take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees i
