EN ISO 14937-2009 en Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development validation and routine control of .pdf

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1、BS EN ISO14937:2009ICS 11.080.01NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDSterilization of healthcare products General requirementsfor characterizationof a sterilizing agentand the development,validation androutine control of asterilization processfor medi

2、cal devices(ISO 14937:2009)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 March2010 BSI 2010ISBN 978 0 580 57850 2Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 14937:2009National forewordThis British Standard is the UK

3、implementation of EN ISO 14937:2009.It supersedes BS EN ISO 14937:2001 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/198, Sterilization of medical devices.A list of organizations represented on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 secret

4、ary.This publication 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 14937 October 2009 IC

5、S 11.080.01 Supersedes EN ISO 14937:2000English Version Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) Strilisation des produi

6、ts de sant - Exigences gnrales pour la caractrisation dun agent strilisant et pour la mise au point, la validation et la vrification de routine dun processus de strilisation pour dispositifs mdicaux (ISO 14937:2009) Sterilisation von Produkten fr die Gesundheitsfrsorge - Allgemeine Anforderungen an

7、die Charakterisierung eines sterilisierenden Agens und an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens fr Medizinprodukte (ISO 14937:2009) This European Standard was approved by CEN on 24 September 2009. CEN members are bound to comply with the CEN/CENELEC In

8、ternal Regulations which 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 Management Centre or to any CEN m

9、ember. This European 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 Management Centre has the same status as the official versions. CEN me

10、mbers are the national standards bodies of 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

11、, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION 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. Re

12、f. No. EN ISO 14937:2009: EBS EN ISO 14937:2009EN ISO 14937:2009 (E) 3 Foreword This document (EN ISO 14937:2009) 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 se

13、cretariat 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 April 2010, and conflicting national standards shall be withdrawn at the latest by April 2010. Attention is drawn

14、 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 EN ISO 14937:2000. This document has been prepared under a mandate given to CEN

15、 by the European Commission and the European Free Trade Association, 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 nationa

16、l standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Pol

17、and, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14937:2009 has been approved by CEN as a EN ISO 14937:2009 without any modification. BS EN ISO 14937:2009EN ISO 14937:2009 (E) 4 Annex ZA (informative) Relationship betwe

18、en 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 by the European Commission and the European Free Trade Association to provide a means of conforming to Essen

19、tial 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 as a national standard in at least one Member State, compliance with the clauses o

20、f 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 regulations. Table ZA.1 Correspondence between this European Standard and Directive 90/385/EEC

21、 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 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) falli

22、ng within the scope of this Standard. BS EN ISO 14937:2009EN ISO 14937:2009 (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 th

23、e 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 implemented

24、 as a national standard in at least one Member State, compliance with the 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

25、. Table ZB.1 Correspondence between this European 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 This relevant Essential Requirement is only partly addressed in this European Standard 4,5,6,7,8

26、,9,10,11,12 8.4 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. BS EN ISO 14937:2009EN ISO 14937:2009 (E) 6 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Direct

27、ive 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 on in vitro d

28、iagnostic 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 s

29、cope 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 EN Essential Requirements (ERs) of Directive 98/79/EC Qu

30、alifying remarks/Notes 4,5,6,7,8,9,10,11,12 2.3 This relevant Essential Requirement is only partly addressed in this European Standard 4,5,6,7,8,9,10,11,12 2.4 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. BS EN ISO

31、14937:2009ISO 14937:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword .v Introductionvi 1 Scope1 1.1 Inclusions.1 1.2 Exclusions1 2 Normative references2 3 Terms and definitions .2 4 Quality management system elements.7 4.1 Documentation 7 4.2 Management responsibility 7 4.3 Product rea

32、lization 8 4.4 Measurement, analysis and improvement Control of non-conforming product8 5 Sterilizing agent characterization 8 5.1 General .8 5.2 Sterilizing agent.8 5.3 Microbicidal effectiveness8 5.4 Effects on materials 9 5.5 Safety and the environment .9 6 Process and equipment characterization

33、.9 6.1 General .9 6.2 Process characterization9 6.3 Equipment characterization .10 7 Product definition10 8 Process definition .11 9 Validation12 9.1 General .12 9.2 Installation qualification .12 9.3 Operational qualification 13 9.4 Performance qualification 13 9.5 Review and approval of validation

34、 14 10 Routine monitoring and control.14 11 Product release from sterilization .14 12 Maintaining process effectiveness15 12.1 General .15 12.2 Recalibration15 12.3 Maintenance of equipment .15 12.4 Requalification.15 12.5 Assessment of change .15 Annex A (normative) Factors to be considered in sele

35、ction of microorganisms for demonstrating microbicidal effectiveness16 Annex B (normative) Approach 1 Process definition based on inactivation of the microbial population in its natural state 18 Annex C (normative) Approach 2 Process definition based on inactivation of reference microorganisms and k

36、nowledge of bioburden 19 BS EN ISO 14937:2009ISO 14937:2009(E) iv ISO 2009 All rights reservedAnnex D (normative) Approach 3 Conservative process definition based on inactivation of reference microorganisms20 Annex E (informative) Guidance on application of this International Standard .22 Bibliograp

37、hy 36 BS EN ISO 14937:2009ISO 14937:2009(E) ISO 2009 All rights reserved vForeword 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 te

38、chnical 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 close

39、ly 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 is to prepare International Standards. Draft

40、 International Standards adopted by the technical 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 docume

41、nt may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14937 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 14937:2000) and IS

42、O 14937:2000/Cor.1:2003 which have been technically revised. BS EN ISO 14937:2009ISO 14937:2009(E) vi ISO 2009 All rights reservedIntroduction A sterile medical device is one that is free of viable microorganisms. International Standards that specify requirements for validation and routine control o

43、f sterilization processes require, when 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 requir

44、ements for quality management systems (see, for example, ISO 13485) could, 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-st

45、erile medical devices into sterile ones. The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices generally can best be described by an exponential relationship between the number of microorganisms surviving and the extent

46、of treatment with the sterilizing agent; inevitably this means that there is always a finite probability that a microorganism might 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 a

47、nd by the environment in which the organisms exist during treatment. It follows that the sterility of any one medical device 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

48、viable microorganism present on a medical device. This International Standard describes requirements that, if met, will provide a sterilization process with appropriate microbicidal activity intended to sterilize medical devices. Furthermore, compliance with the requirements ensures that the sterili

49、zation process is both reliable and reproducible so that predictions can be made, with reasonable confidence, that there is a low level of probability of there being a viable microorganism present on a medical device after sterilization. Specification of this probability is a matter for regulatory authorities and can vary from country to country (see, for example, EN 556-1 and ANSI/AAMI ST67). Generic requirements of the quality management system for design and development, production, installation and servicing are given in ISO 900