1、BS EN ISO11737-2:2009ICS 07.100.10; 11.080.01NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterilization ofmedical devices MicrobiologicalmethodsPart 2: Tests of sterility performedin the definition, validation andmaintenance of a sterilization process(ISO 117
2、37-2:2009)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 March2010 BSI 2010ISBN 978 0 580 57852 6Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 11737-2:2009National forewordThis British Standard is the UK implementation
3、of EN ISO11737-2:2009. It supersedes BS EN ISO 11737-2:2000 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/198, Sterilization of medical devices.A list of organizations represented on this committee can be obtained onrequest to its secretary.This pub
4、lication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11737-2 November 2009 ICS 07.100.
5、10; 11.080.01 Supersedes EN ISO 11737-2:2000English Version Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) Strilisation des dispositifs mdicaux - Mthodes mic
6、robiologiques - Partie 2: Contrles de strilit pratiqus au moment de la dfinition, de la validation et de la maintenance dun procd de strilisation (ISO 11737-2:2009) Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 2: Prfungen der Sterilitt bei der Definition, Validierung und Au
7、frechterhaltung eines Sterilisationsverfahrens fr Medizinprodukte (ISO 11737-2:2009) This European Standard was approved by CEN on 28 October 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of
8、 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 Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A vers
9、ion in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, De
10、nmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALI
11、SATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11737-2:2009: EBS EN ISO 11737-2:2009EN ISO 11737-2:2009 (E) 3 Foreword This docume
12、nt (EN ISO 11737-2:2009) 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 the status of a
13、national standard, either by publication of an identical text or by endorsement, at the latest by May 2010, and conflicting national standards shall be withdrawn at the latest by May 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent r
14、ights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11737-2:2000. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential
15、 requirements of EU Directives. For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are integral parts of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Europe
16、an Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United K
17、ingdom. Endorsement notice The text of ISO 11737-2:2009 has been approved by CEN as a EN ISO 11737-2:2009 without any modification. BS EN ISO 11737-2:2009EN ISO 11737-2:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385
18、/EEC on Active Implantable 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 90/385/EEC on active implantabl
19、e 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 ZA.1 confers, within the limits of the scope of
20、this standard, a presumption of conformity with the corresponding 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 Directive 90
21、/385/EECQualifying remarks/Notes 4,5,6,7,8 7 This relevant Essential Requirement is only partly addressed in this European Standard WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 11737-2:2009EN ISO 11737-2:
22、2009 (E) 5 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 by the European Commission and the European Free Trade Association to provid
23、e 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 implemented as a national standard in at least one Member State, compliance with t
24、he 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 EFTA regulations. Table ZB.1 Correspondence between this European Standard and Directiv
25、e 93/42/EEC Clauses of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4,5,6,7,8 8.3 This relevant Essential Requirement is only partly addressed in this European Standard 4,5,6,7,8 8.4 This relevant Essential Requirement is only partly addressed i
26、n this European Standard WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 11737-2:2009EN ISO 11737-2:2009 (E) 6 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements
27、 of EU Directive 98/79/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
28、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 clauses of this standard given in Table ZC.1 confers, within the li
29、mits of the scope of this 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 (E
30、Rs) of Directive 98/79/EC Qualifying remarks/Notes 4,5,6,7,8 B.2.3 This relevant Essential Requirement is only partly addressed in this European Standard 4,5,6,7,8 B.2.4 This relevant Essential Requirement is only partly addressed in this European Standard WARNING Other requirements and other EU Dir
31、ectives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 11737-2:2009ISO 11737-2:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Quality management system elements.3
32、 4.1 Documentation 3 4.2 Management responsibility 3 4.3 Product realization 4 4.4 Measurement, analysis and improvement4 5 Selection of product4 5.1 General .4 5.2 Sample item portion (SIP).4 5.3 Packaging of product and sample item portions.5 6 Methods for performing tests of sterility 5 7 Assessm
33、ent of method for performing tests of sterility .6 8 Maintenance of the method for performing tests of sterility 6 Annex A (informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process7 Bibliography15 BS EN ISO 11737-2:2009ISO 11737-2:2009(E) iv ISO
34、2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in
35、 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 Commiss
36、ion (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 is to prepare International Standards. Draft International Standards adopted by the technical
37、committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall
38、not be held responsible for identifying any or all such patent rights. ISO 11737-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 11737-2:1998) which has been technically revised. ISO 11737 consis
39、ts of the following parts, under the general title Sterilization of medical devices Microbiological methods: Part 1: Determination of a population of microorganisms on products Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process BS EN ISO 117
40、37-2:2009ISO 11737-2:2009(E) ISO 2009 All rights reserved vIntroduction A sterile medical device is one that is free from viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes require, when it is necessary to supply a s
41、terile medical device, that adventitious microbiological contamination of a medical device from all sources be minimized. Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (see, for example, ISO 13485) may, pr
42、ior to sterilization, have microorganisms on them, albeit in low numbers. Such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones. The kinetics of inactivation of a pure culture of
43、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 fini
44、te probability that a microorganism may survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. It follows that the ste
45、rility of any one item in a population subjected to sterilization processing cannot be guaranteed and the sterility of a processed population is defined in terms of the probability of there being a viable microorganism present on a product item. Generic requirements of the quality management system
46、for design and development, production, installation and servicing are given in ISO 900116and particular requirements for quality management systems for medical device production are given in ISO 13485. The standards for quality management systems recognise that, for certain processes used in manufa
47、cturing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterilization process is monitored routinely a
48、nd the equipment is maintained. International Standards specifying procedures for the development, validation and routine control of the processes used for sterilization of medical devices have been prepared (see ISO 11135-11, ISO 11137-13, ISO 1493712, ISO 141607, ISO 17665-113and ISO 2085714). An
49、element of validation might consist of exposing medical devices to the sterilizing agent with the extent of treatment being reduced relative to that which will be used in routine sterilization processing, in order to provide a knowledge of the resistance to the agent of the microbial contamination as it occurs naturally on medical devices. Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of ISO 11737. Examples of the use of such tests are in a) establishin
