1、BSI Standards PublicationBS EN ISO 11137-1:2015Sterilization of health careproducts RadiationPart 1: Requirements for development,validation and routine control of asterilization process for medical devicesBS EN ISO 11137-1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implem
2、entation of EN ISO11137-1:2015. It is identical to ISO 11137-1:2006, The UK participation in its preparation was entrusted to TechnicalCommittee CH/198, Sterilization and Associated Equipment andProcesses.A list of organizations represented on this committee can beobtained on request to its secretar
3、y.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 90757 9ICS 11.080.01Compliance with a British Standard cannot confe
4、r immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2006.Amendments/corrigenda issued since publicationDate Text affectedThe start and finish of text introduced or altered by amendment is indicated in the
5、 text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is indicated by !“.BS EN ISO 11137-1:2006+A1:2013 which is withdrawn.incorporating amendment 1:2013. It supersedes 31 August 2013 Implementation of ISO amendment 1:2
6、013 with CEN endorsement A1:2013: Annex ZA updated; Annex ZB and Annex ZC inserted31 July 2015 CEN have reissued this document with the updated identifier EN ISO 11137-1:2015, which has been reflected in the BSI adoption of this standardEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11137-
7、1June 2015 ICS 11.080.01 English Version Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) Strilisation des produits de sant - Irradiation -
8、Partie 1: Exigences relatives la mise au point, la validation et au contrle de routine dun procd de strilisation pour les dispositifs mdicaux (ISO 11137-1:2006, y compris Amd 1:2013) Sterilisation von Produkten fr die Gesundheitsfrsorge - Strahlen - Teil 1: Anforderungen an die Entwicklung, Validier
9、ung und Lenkung der Anwendung eines Sterilisationsverfahrens fr Medizinprodukte (ISO 11137-1:2006, einschlielich Amd 1:2013) 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
10、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 European Standard exists in three officia
11、l 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 are the national standards bodies of Au
12、stria, 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, Slovakia, Slovenia, Spain, Swe
13、den, 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 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for C
14、EN national Members. Ref. No. EN ISO 11137-1:2015 Eii Foreword The text of ISO 11137-1:2006, including Amd 1:2013 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
15、11137-1:2015 by 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 confli
16、cting national 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 docum
17、ent supersedes EN ISO 11137-1:2006. 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, ZC, which ar
18、e an integral part 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. Howeve
19、r, for any use 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 th
20、e ISO standard 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 e
21、xtent (in whole 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 10012-1 EN ISO 10012:2003 ISO 10012:2003 ISO 11137-2 EN ISO 11137-2:2013
22、ISO 11137-2:2013 ISO 11737-1 EN ISO 11737-1:2006 + AC:2009 ISO 11737-1:2006 + Cor 1:2007 ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009 ISO 13485 EN ISO 13485:2012 ISO 13485:2003 BS EN ISO 11137-1:2015EN ISO 11137-1:2015 (E)According to the CEN-CENELEC Internal Regulations, the national standards
23、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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembo
24、urg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11137-1:2006, including Amd 1:2013 has been approved by CEN as EN ISO 11137-1:2015 without any modification. BS EN ISO 11137-1
25、:2015EN ISO 11137-1:2015 (E)iii Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices This European Standard has been prepared under a mandate given to CEN/CENELEC by the European Commission
26、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 Official Journal of the European Union under that Directive and has been implemented a
27、s 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 the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA reg
28、ulations. 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 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
29、 level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk 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 refer
30、ences 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 appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard an
31、d Directive 90/385/EEC Clauses of this EN Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10,11,12 7 Only a sterilization process using ionizing radiation is considered by this standard. This relevant Essential Requirement is only partly addressed in this Eu
32、ropean Standard. Design and packaging for maintenance of sterility during transportation and storage are not covered. Aspects of manufacture other than those related to sterilization are not covered. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling withi
33、n the scope of this Standard. BS EN ISO 11137-1:2015EN ISO 11137-1:2015 (E)iv Annex ZB (informative) Relationship between 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/CENELC by
34、 the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of 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 implemen
35、ted as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZB.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 EFT
36、A 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 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 poss
37、ible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining 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 n
38、ormative 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 appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZB.1 Correspondence between this Europe
39、an Standard and Directive 93/42/EEC Clauses of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10,11,12 8.3 Only a sterilization process using ionizing radiation is considered by this standard. This relevant Essential Requirement is only partly addres
40、sed in this European Standard. Design and packaging for maintenance of sterility during transportation and storage are not covered. Aspects of manufacture other than those related to sterilization are not covered. 4,5,6,7,8,9,10,11,12 8.4 This relevant Essential Requirement is only partly addressed
41、in this European Standard. Aspects of manufacture 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. BS EN ISO 11137-1:2015EN ISO 11137-1:2015 (E)v Annex ZC (info
42、rmative) Relationship between this European Standard and the Essential 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 prov
43、ide a means of conforming to Essential Requirements of the New Approach 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 Sta
44、te, compliance with the normative clauses of this standard given in Table 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
45、 of this standard to the risk management process is made, the risk management 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
46、essential requirement. NOTE 2 The manufacturers policy for determining 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
47、the European foreword, replacing the references in the core text. NOTE 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 EN Essent
48、ial Requirements (ERs) of Directive 98/79/EC Qualifying remarks/Notes 4,5,6,7,8,9,10,11,12 B.2.3 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 main
49、tenance of sterility during transportation and storage are not covered. Aspects of manufacture other than those related to sterilization are not covered. BS EN ISO 11137-1:2015EN ISO 11137-1:2015 (E)vi 4,5,6,7,8,9,10,11,12 B.2.4 This relevant Essential requirement is addressed only with regard to: - sterilization, not covering other special microbiological state - devices for which sterilization by radiation is appropriate WARNING Other req
