1、November 2015 English price group 20No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.080.99!%GR7“2364720www.din.d
2、eDIN EN ISO 11137-1Sterilization 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);English version EN ISO 11137-1:2015,English translation of DIN EN ISO 11137-
3、1:2015-11Sterilisation von Produkten fr die Gesundheitsfrsorge Strahlen Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens fr Medizinprodukte (ISO 11137-1:2006, einschlielich Amd 1:2013);Englische Fassung EN ISO 11137-1:2015,Englische berse
4、tzung von DIN EN ISO 11137-1:2015-11Strilisation des produits de sant Irradiation 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);Version anglaise EN ISO 11137-1:201
5、5,Traduction anglaise de DIN EN ISO 11137-1:2015-11SupersedesDIN EN ISO 11137-1:2013-12www.beuth.deDocument comprises 50 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.11.15 DIN EN ISO 11137-1:2015-11 2 A comma is used as the
6、decimal marker. National foreword This document (EN ISO 11137-1:2015) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 204 “Sterilizers for medical purposes” (Secretariat: BSI, United Kingdom). The responsibl
7、e German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medical), Working Committee NA 063-01-07 AA Sterilisation von Medizinprodukten. According to Resolution CEN/BT C51/2015 Annexes ZA, ZB and ZC and the European Foreword have been updated and published i
8、n June 2015 as a new edition of EN ISO 11137-1:2015. Thus, this new edition of DIN EN ISO 11137-1 has also been published. This document contains ISO 11137-1:2006 including Amendment 1:2013 unchanged. DIN EN ISO 11137 consists of the following parts, under the general title Sterilization of health c
9、are products Radiation: Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices Part 2: Establishing the sterilization dose Part 3: Guidance on dosimetric aspects The DIN Standards corresponding to the International Standards referred to in
10、 this document are as follows: ISO 9000 ISO 9001 DIN EN ISO 9000 DIN EN ISO 9001 ISO 10993-1 DIN EN ISO 10993-1ISO 11137-2 DIN EN ISO 11137-2ISO 11137-3 ISO 11607-1 DIN EN ISO 11137-3DIN EN ISO 11607-1ISO 11607-2 ISO 11737-1 DIN EN ISO 11607-2DIN EN ISO 11737-1ISO 11737-2 ISO 13485 DIN EN ISO 11737-
11、2DIN EN ISO 13485 ISO 14001 DIN EN ISO 14001 ISO 14040 ISO 22442-1 DIN EN ISO 14040 DIN EN ISO 22442-1ISO 22442-2 ISO 22442-3 DIN EN ISO 22442-2DIN EN ISO 22442-3Amendments This standard differs from DIN EN ISO 11137-1:2013-12 as follows: a) the European foreword has been updated; b) in the German v
12、ersion, the term “3.13 erarbeiten” has been harmonized with DIN EN ISO 14937; DIN EN ISO 11137-1:2015-11 3 c) in the German version, the informative Clause A.7 has partly been revised; d) in the German version, in Table A.3, the specifications for testing the conveyor speed monitoring and/or control
13、 circuitry have been corrected; e) Annex ZA (informative) “Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices” has been updated; f) Annex ZB (informative) “Relationship between this European Standard and the Ess
14、ential Requirements of EU Directive 93/42/EEC on medical devices” has been updated; g) Annex ZC (informative) “Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices” has been updated; Previous editions DIN EN 552: 1
15、994-11, 2001-02 DIN EN 552 Corrigendum 1: 1999-07 DIN EN ISO 11137-1: 2006-07, 2013-12 DIN EN ISO 11137-1:2015-11 4 National Annex NA (informative) Bibliography DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO
16、 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose DIN EN ISO 11137-3, Sterilization of health care products Radiation Part 3
17、: Guidance on dosimetric aspects DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for formi
18、ng, sealing and assembly processes DIN EN ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products DIN EN ISO 11737-2, Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the
19、 definition, validation and maintenance of a sterilization process DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14001, Environmental management systems Requirements with guidance for use DIN EN ISO 14040, Environmental management Life c
20、ycle assessment Principles and framework DIN EN ISO 22442-1, Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management DIN EN ISO 22442-2, Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
21、DIN EN ISO 22442-3, Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11137-1 June 2015 ICS 11.080.01 Supersede
22、s EN ISO 11137-1:2006English 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 - Part
23、ie 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, Validierung
24、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 this
25、 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 official ve
26、rsions (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 Austri
27、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, Slovakia, Slovenia, Spain, Sweden,
28、 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 CEN n
29、ational Members. Ref. No. EN ISO 11137-1:2015 EContents Page Foreword 3Introduction 4 1 Scope . 6 2 Normative references . 7 3 Terms and definitions. 7 4 Quality management system elements 13 4.1 Documentation 13 4.2 Management responsibility . 14 4.3 Product realization 14 4.4 Measurement, analysis
30、 and improvement Control of nonconforming product 14 5 Sterilizing agent characterization . 14 5.1 Sterilizing agent 14 5.2 Microbicidal effectiveness . 14 5.3 Material effects 14 5.4 Environmental considerations 15 6 Process and equipment characterization 15 6.1 Process 15 6.2 Equipment . 15 7 Prod
31、uct definition . 16 8 Process definition. 17 8.1 Establishing the maximum acceptable dose . 17 8.2 Establishing the sterilization dose 17 8.3 Specifying the maximum acceptable dose and the sterilization dose 18 8.4 Transference of maximum acceptable, verification or sterilization dose between radiat
32、ion sources 18 9 Validation. 19 9.1 Installation qualification. 19 9.2 Operational qualification 19 9.3 Performance qualification 20 9.4 Review and approval of validation 20 10 Routine monitoring and control 21 11 Product release from sterilization. 22 12 Maintaining process effectiveness . 22 12.1
33、Demonstration of continued effectiveness 22 12.2 Recalibration . 25 12.3 Maintenance of equipment 25 12.4 Requalification of equipment 25 12.5 Assessment of change. 25 Annex A (informative) Guidance. 26 Bibliography . EN ISO 11137-1:2015 (E) 2 54Annex ZA (informative) Relationship between this Europ
34、ean Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices . 41 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 42 Annex ZC (informative) Relationship betw
35、een this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices 43 DIN EN ISO 11137-1:2015-11 .Foreword EN ISO 11137-1:2015 (E) 3 DIN EN ISO 11137-1:2015-11 The text of ISO 11137-1:2006, including Amd 1:2013 has been prepared by Technical Com
36、mittee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11137-1:2015 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of which is held by BSI. This European Standard sh
37、all 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 standards shall be withdrawn at the latest by December 2015. Attention is drawn to the possibility that some of the elements of this
38、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 EN ISO 11137-1:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Tr
39、ade Association, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annexes ZA, ZB, ZC, which are an integral part of this document. The following referenced documents are indispensable for the application of this document. For undated referenc
40、es, the edition of the referenced document (including any amendments) listed below applies. For dated references, only the edition cited applies. However, 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 sup
41、erseded 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 text, this should be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated v
42、ersion 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 whole or in part) to which they apply. Table Correlation between normative references and dated EN and ISO standards Normative references
43、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 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
44、EN ISO 13485:2012 ISO 13485:2003 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, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav R
45、epublic 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 Kingdom. Endorsement notice The text of ISO 11137-1:2006, inclu
46、ding Amd 1:2013 has been approved by CEN as EN ISO 11137-1:2015 without any modification. Introduction A sterile medical device is one that is free of viable microorganisms. International Standards, which specify requirements for validation and routine control of sterilization processes, require, wh
47、en it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems
48、 (see, for example, ISO 13485) may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such medical devices are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones
49、. The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices can generally best be described by an exponential relationship between the numbers of microorganisms surviving and the extent of treatment with the sterilizing agent; inevitably this means that there is always a finite probability that a microorganism may survive regardless of t
