BS EN ISO 20857-2013 Sterilization of health care products Dry heat Requirements for the development validation and routine control of a sterilization process for medical devices《保.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 20857:2013Sterilization of healthcare products Dry heat Requirements for thedevelopment, validation and routine control of asterilization process for medical devicesBS

2、EN ISO 20857:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 20857:2013. It is identical to ISO 20857:2010.The UK participation in its preparation was entrusted to TechnicalCommittee CH/198, Sterilization of medical devices.A list of organizations repre

3、sented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013.Published by BSI Standards Limited 2013 ISBN 978 0 580

4、77933 6 ICS 11.080.01 Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2013. Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME E

5、UROPENNE EUROPISCHE NORM EN ISO 20857 April 2013 ICS 11.080.01 English Version Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) Strilisation des produits de sant - Chale

6、ur sche - Exigences pour llaboration, la validation et le contrle de routine dun processus de strilisation pour dispositifs mdicaux (ISO 20857:2010) Sterilisation von Produkten fr die Gesundheitsfrsorge - Trockene Hitze - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung von in

7、dustriellen Sterilisationsverfahren fr Medizinprodukte (ISO 20857:2010) This European Standard was approved by CEN on 5 April 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national stan

8、dard 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 (English, French, German). A version in a

9、ny 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, Belgium, Bulgaria, Croatia, Cyprus, Czech Rep

10、ublic, 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 United Kingdom. EUROPEA

11、N COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 20857:2013: EBS EN ISO 2085

12、7:2013EN ISO 20857:2013 (E) 3 Foreword The text of ISO 20857:2010 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 20857:2013 by Technical Committee CEN/TC 204 “St

13、erilization 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 October 2013, and conflicting national standards shall be withdrawn at the

14、latest by October 2013. 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 has been prepared under a mandate given to CEN b

15、y 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 national

16、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 Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuani

17、a, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 20857:2010 has been approved by CEN as EN ISO 20857:2013 without any modification. BS EN ISO 20857:2013EN ISO 20857:

18、2013 (E) 4 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 by the European Commission and the European Free Trade A

19、ssociation 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 as a national standard in at l

20、east one Member State, compliance with the 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 regulations. Table ZA.1 Correspondence bet

21、ween this European Standard and 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 This relevant Essential Requirement is only partly addressed in this European Standard. Packaging for maintenance of sterility

22、during transportation and storage 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 20857:2013EN ISO 20857:2013 (E) 5 Annex ZB (informative) Relationship between this European Standard and the E

23、ssential 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 provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/E

24、EC 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 clauses of this standard given in Table ZB.1 confers, within the limits of the scope

25、 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 Directive 93/42/EEC Clauses of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qual

26、ifying 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. Packaging for maintenance of sterility during transportation and storage are not covered 4,5,6,7,8,9,10,11,12 8.4 WARNING Other requirements and other EU Directives m

27、ay be applicable to the product(s) falling within the scope of this Standard. BS EN ISO 20857:2013EN ISO 20857:2013 (E) 6 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices This European St

28、andard 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 diagnostic medical devices. Once this standard is cited in the Offici

29、al 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 scope of this standard, a presumption of conformity with the correspo

30、nding 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 Qualifying remarks/Notes 4,5,6,7,8,9,10,11,12 B.2.3 This relevant Esse

31、ntial Requirement is only partly addressed in this European Standard. Packaging for maintenance of sterility during transportation and storage are not covered 4,5,6,7,8,9,10,11,12 B.2.4 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of

32、 this Standard. BS EN ISO 20857:2013ISO 20857:2010(E) ISO 2010 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.10 4.1 Documentation 10 4.2 Management resp

33、onsibility 10 4.3 Product realization 10 4.4 Measurement, analysis and improvement Control of nonconforming product.10 5 Sterilizing agent characterization11 5.1 Sterilizing agent.11 5.2 Microbicidal effectiveness11 5.3 Material effects 11 5.4 Environmental considerations.11 6 Process and equipment

34、characterization .11 6.1 Process characterization11 6.2 Equipment characterization .11 7 Product definition13 7.1 General .13 7.2 Product safety and performance .13 7.3 Packaging considerations14 7.4 Microbiological quality14 7.5 Product family14 7.6 Biological safety14 8 Process definition .15 9 Va

35、lidation .16 9.1 General .16 9.2 Installation qualification .16 9.3 Operational qualification 16 9.4 Performance qualification 16 9.5 Additional sterilization systems 18 9.6 Review and approval of validation 18 10 Routine monitoring and control.19 10.1 Routine control 19 10.2 Routine monitoring .19

36、10.3 Process monitoring locations20 11 Product release from sterilization/depyrogenation .21 12 Maintaining process effectiveness21 12.1 General .21 12.2 Recalibration21 12.3 Maintenance of equipment .21 12.4 Requalification.21 12.5 Assessment of change .22 BS EN ISO 20857:2013ISO 20857:2010(E) iv I

37、SO 2010 All rights reservedAnnex A (informative) Guidance on the application of this International Standard .23 Annex B (informative) Process definition based on inactivation of the microbial population in its natural state (bioburden-based approach) .46 Annex C (informative) Process definition base

38、d on the inactivation of reference microorganisms and knowledge of bioburden (combined bioburden/biological indicator approach) .48 Annex D (informative) Conservative process definition based on inactivation of reference microorganisms (overkill method).51 Annex E (informative) Process development 5

39、4 Bibliography 57 BS EN ISO 20857:2013ISO 20857:2010(E) ISO 2010 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 th

40、rough ISO technical 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 collab

41、orates closely 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 Stan

42、dards. Draft 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

43、 this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 20857 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. BS EN ISO 20857:2013ISO 20857:2010(E) vi ISO 2010 All rights reservedI

44、ntroduction A sterile medical device is one that is free of viable microorganisms. International Standards that specify requirements for development, validation and routine control of sterilization processes, require, when it is necessary to supply a sterile medical device, that adventitious microbi

45、ological 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 (see, for example, ISO 13485) may, prior to sterilization, have microorganisms

46、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 microorganisms by physical and/or chemical

47、 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 su

48、rvive 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 sterility of any one product in a population

49、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. This International Standard describes requirements that, if met, will provide a dry heat sterilization process capable of sterilizing medical devices through appropriate microbicidal activity. This International Standard also describes requirements that, if met, will provide a dry heat depyrogenation process through an appropriate denatur