BS EN ISO 11137-2-2015 Sterilization of health care products Radiation Establishing the sterilization dose《保健产品的灭菌 辐射 杀菌剂量的确定》.pdf

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1、BSI Standards PublicationBS EN ISO 11137-2:2015Sterilization of health careproducts RadiationPart 2: Establishing the sterilization doseBS EN ISO 11137-2:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11137-2:2015. It is identical to ISO 11137-2:2013.

2、It supersedes BS EN ISO 11137-2:2013 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of organizations represented on this committee can be obtained on request to its secretary.This pub

3、lication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 90759 3ICS 11.080.01Compliance with a British Standard cannot confer immuni

4、ty from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11137-2 June 2015 ICS 11

5、.080.01 Supersedes EN ISO 11137-2:2013English 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 dose strilisante (ISO 11137-2:2013) Sterilisation vo

6、n Produkten fr die Gesundheitsfrsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO 11137-2:2013) This European Standard was approved by CEN on 20 May 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europea

7、n 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 European Standard exists in three official versions (

8、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 are the national standards bodies of Austria, Belgi

9、um, 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, Slovakia, Slovenia, Spain, Sweden, Switzer

10、land, 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 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national

11、Members. Ref. No. EN ISO 11137-2:2015 EBS EN ISO 11137-2:2015Foreword The text of ISO 11137-2:2013 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11137-2:2015 by

12、 Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of which is held by BSI. 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 December 2015, and conflicting national

13、standards shall be withdrawn at the latest by December 2015. Attention is drawn to the possibility that some of the elements of this document may 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

14、EN ISO 11137-2:2013. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are integral p

15、arts of this document. The following referenced documents are indispensable for the application of this document. For undated references, the edition of the referenced document (including any amendments) listed below applies. For dated references, only the edition cited applies. However, for any use

16、 of this standard within the meaning of Annex ZA, ZB or ZC, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard

17、 text, this should be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whol

18、e or in part) to which they apply. Table Correlation between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 11137 EN ISO 11137-1:2006/A1:2013 ISO 11137-1:2006/A1:2013 ISO 11737-1 EN ISO 11737-1:2

19、006 + AC:2009 ISO 11737-1:2006 + Cor 1:2007 ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009 According 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,

20、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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kin

21、gdom. Endorsement notice The text of ISO 11137-2:2013 has been approved by CEN as EN ISO 11137-2:2015 without any modification. EN ISO 11137-2:2015 (E)BS EN ISO 11137-2:2015Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on

22、 active implantable medical devices This European Standard has been prepared under a mandate given to CEN/CENELEC 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 implantab

23、le 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 normative clauses of this standard given in Table ZA.1 confers, within the limits of th

24、e scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance

25、 with 90/385/EEC, as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable r

26、isk must be in compliance with essential requirements 1, 4, 5, 8, 9 and 10 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not a

27、ppear in Table ZA.1, it means that it is not addressed by this European Standard. 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, 10

28、7 Only a sterilization process using ionizing radiation is considered by this standard. This relevant Essential Requirement is only partly addressed in this European Standard. Design and packaging for maintenance of sterility during transportation and storage are not covered. Aspects of manufacture

29、other than those related to sterilization are not covered. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. EN ISO 11137-2:2015 (E)BS EN ISO 11137-2:2015Annex ZB (informative) Relationship between this European Standard

30、 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/CENELC by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach

31、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 normative clauses of this standard given in Table ZB.1 confers, wit

32、hin the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs

33、 to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for deter

34、mining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Ess

35、ential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZB.1 Correspondence between this European Standard and EU Directive 93/42/EEC Clauses of this European Standard Essential Requirements (ERs) of EU Directive 93/42/EEC Qualifying remar

36、ks/Notes 4, 5, 6, 7, 8, 9, 10 8.3 Only a sterilization process using inoizing radiation is considered by this standard. This relevant ER is only partly addressed in this International Standard and only in conjunction with ISO 11137-1. Design and packaging for maintenance of sterility during transpor

37、tation and storage are not covered. Aspects of manufacture other than those related to sterilization are not covered. 4, 5, 6, 7, 8, 9, 10 8.4 This relevant ER is only partly addressed in this International Standard and only in conjunction with ISO 11137-1. Aspects of manufacture other than those re

38、lated to sterilization are not covered. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. EN ISO 11137-2:2015 (E)BS EN ISO 11137-2:2015Annex ZC (informative) Relationship between this European Standard and the Essential

39、Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices This European Standard has been prepared under a mandate given to CEN/CENELEC by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach

40、 Directive 98/79/EC on in vitro diagnostic 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 normative clauses of this standard given in Tab

41、le ZC.1 confers, 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. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk mana

42、gement process needs to be in compliance with 98/79/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining

43、acceptable risk must be in compliance with essential requirements Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6, and 7 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE

44、4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZC.1 Correspondence between this European Standard and Directive 98/79/EC Clauses of this European Standard Essential Requirements (ERs) of EU Directive 98/79/EC Qualifyi

45、ng remarks/Notes 4, 5, 6, 7, 8, 9, 10 B.2.3 Only a sterilization process using inoizing radiation is considered by this standard. This relevant ER is only partly addressed in this International Standard and only in conjunction with ISO 11137-1. Design and packaging for maintenance of sterility durin

46、g transportation and storage are not covered. Aspects of manufacture other than those related to sterilization are not covered. EN ISO 11137-2:2015 (E)BS EN ISO 11137-2:20154, 5, 6, 7, 8, 9, 10 B.2.4 This relevant Essential requirement is addressed in this International Standard in conjunction with

47、ISO 11137-1 and only with regard to: - sterilization, not covering other special microbiological state - devices for which sterilization by radiation is appropriate . WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. EN

48、ISO 11137-2:2015 (E)BS EN ISO 11137-2:2015ISO 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 definitions . 13.2 Abbreviated terms . 34 Definition and maintenance of

49、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 dose 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