DIN EN ISO 14937-2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development validation and routine control ofO.pdf

1、March 2010 Translation by DIN-Sprachendienst.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

2、11.080.01!$a.;“1621124www.din.deDDIN EN ISO 14937Sterilization of health care products General requirements for characterization of a sterilizing agent and thedevelopment, validation and routine control of a sterilization process formedical devices (ISO 14937:2009)English translation of DIN EN ISO 1

3、4937:2010-03Sterilisation von Produkten fr die Gesundheitsfrsorge Allgemeine Anforderungen an die Charakterisierung eines sterilisierenden Agens und andie Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrensfr Medizinprodukte (ISO 14937:2009)Englische bersetzung von DIN

4、EN ISO 14937:2010-03Strilisation des produits 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 dispositifsmdicaux (ISO 14937:2009)Traduction anglaise de DIN EN ISO 14937:2010-0

5、3SupersedesDIN EN ISO 14937:2001-05 andwww.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 50 pagesCorrigendum 1:2005-06DIN EN ISO 14937 03.10 DIN EN ISO 14937:2010-03 2 A comma is used as the decimal marker. National foreword This document

6、 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” (Secretariat: ANSI, United States), in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” (Secretariat: BSI, United Kingdom). The responsible German body involved in its pre

7、paration was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-01-07 AA Sterilisation von Medizinprodukten. The DIN Standards corresponding to the International Standards referred to in this standard are as follows: ISO 9000 DIN EN ISO 9000 ISO 9001 DIN EN ISO 9001

8、ISO 9004 DIN EN ISO 9004 ISO 10012 DIN EN ISO 10012 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-17 DIN EN ISO 10993-17 ISO 11135-1 DIN EN ISO 11135-1 ISO 11138-1 DIN EN ISO 11138-1 ISO 11137-1 DIN EN ISO 11137-1 ISO 11137-2 DIN EN ISO 11137-2 ISO 11140-1 DIN EN ISO 11140-1 ISO 11607-1 DIN EN ISO 11607-

9、1 ISO 11607-2 DIN EN ISO 11607-2 ISO 11737-1 DIN EN ISO 11737-1 ISO 11737-2 DIN EN ISO 11737-2 ISO 13485 DIN EN ISO 13485 ISO 14001 DIN EN ISO 14001 ISO 14040 DIN EN ISO 14040 ISO 14160 DIN EN ISO 14160 ISO 14161 DIN EN ISO 14161 ISO 14971 DIN EN ISO 14971 ISO/IEC 17025 DIN EN ISO/IEC 17025 ISO 1766

10、4 DIN EN ISO 17664 ISO 17665-1 DIN EN ISO 17665-1 ISO 15883 (all parts) DIN EN ISO 15883 (all parts) ISO 22442-1 DIN EN ISO 22442-1 ISO 22442-2 DIN EN ISO 22442-2 ISO 22442-3 DIN EN ISO 22442-3 IEC 61010-2-040 DIN EN 61010-2-040 (VDE 0411-2-040) Amendments This standard differs from DIN EN ISO 14937

11、:2001-05 and DIN EN ISO 14937 Corrigendum 1:2005-06 as follows: a) The requirements for quality management system elements have been revised. b) The requirements for product release from sterilization and assessment of change have been extended. c) Annex E “Guidance on application of this Internatio

12、nal Standard” has been included. d) The standard has been editorially revised. DIN EN ISO 14937:2010-03 3 Previous editions DIN EN ISO 14937: 2001-05 DIN EN ISO 14937 Corrigendum1: 2005-06 National Annex NA (informative) Bibliography DIN EN 61010-2-040 (VDE 0411-2-040), Safety requirements for elect

13、rical equipment for measurement, control and laboratory use Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 9001, Quality management systems Requirements DIN

14、 EN ISO 9004, Quality management systems Guidelines for performance improvements DIN EN ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing DIN EN ISO 1099

15、3-17, Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances DIN EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical

16、devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization d

17、ose DIN EN ISO 11138-1, Sterilization of health care products Biological indicators Part 1: General requirements DIN EN ISO 11140-1, Sterilization of health care products Chemical indicators Part 1: General requirements DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1:

18、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 forming, sealing and assembly processes DIN EN ISO 11737-1, Sterilization of medical devices Microbiological methods P

19、art 1: Determination of a population of microorganisms on products DIN EN ISO 14937:2010-03 4 DIN EN ISO 11737-2, Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process DIN EN ISO 13485, M

20、edical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14001, Environmental management systems Specifications with guidance for use DIN EN ISO 14040, Environmental management Life cycle assessment Principles and framework DIN EN ISO 14160, Sterilization of single-u

21、se medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants DIN EN ISO 14161, Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results DIN EN ISO 14971, Medi

22、cal devices Application of risk management to medical devices DIN EN ISO 15883 (all parts), Washer-disinfectors DIN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories DIN EN ISO 17664, Sterilization of medical devices Information to be provided by the m

23、anufacturer for the processing of resterilizable medical devices DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 22442-1, Medical devices utilizing

24、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 DIN EN ISO 22442-3, Medical devices utilizing animal tissues and their derivatives Part

25、 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14937 October 2009 ICS 11.080.01 Supersedes EN ISO 14937:2000English Version Sterilization of health care products - General requireme

26、nts 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 produits de sant - Exigences gnrales pour la caractrisation dun agent strilisant et pour la mise au point, la validatio

27、n et la vrification de routine dun processus de strilisation pour dispositifs mdicaux (ISO 14937:2009) Sterilisation von Produkten fr die Gesundheitsfrsorge - Allgemeine Anforderungen an die Charakterisierung eines sterilisierenden Agens und an die Entwicklung, Validierung und Lenkung der Anwendung

28、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 Internal Regulations which stipulate the conditions for giving this European Standard the status of a national stan

29、dard 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 version in any other

30、 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, Denmark, Estonia,

31、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 NORMALISATION EUROPISCH

32、ES 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 14937:2009: EContents DIN EN ISO 14937:2010-03 EN ISO 14937:2009 (E) 2 Page Foreword .4 Introductio

33、n.5 1 Scope7 1.1 Inclusions.7 1.2 Exclusions7 2 Normative references8 3 Terms and definitions .8 4 Quality management system elements.13 4.1 Documentation 13 4.2 Management responsibility 13 4.3 Product realization 14 4.4 Measurement, analysis and improvement Control of non-conforming product14 5 St

34、erilizing agent characterization 14 5.1 General .14 5.2 Sterilizing agent.14 5.3 Microbicidal effectiveness14 5.4 Effects on materials 15 5.5 Safety and the environment .15 6 Process and equipment characterization .15 6.1 General .15 6.2 Process characterization15 6.3 Equipment characterization .16

35、7 Product definition16 8 Process definition .17 9 Validation .18 9.1 General .18 9.2 Installation qualification .18 9.3 Operational qualification 19 9.4 Performance qualification 19 9.5 Review and approval of validation 20 10 Routine monitoring and control.20 11 Product release from sterilization .2

36、0 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 .21 Annex A (normative) Factors to be considered in selection of microorganisms for demonstrating microbicidal effectiveness .22 Annex B

37、(normative) Approach 1 Process definition based on inactivation of the microbial population in its natural state 24 Annex C (normative) Approach 2 Process definition based on inactivation of reference microorganisms and knowledge of bioburden 25 DIN EN ISO 14937:2010-03 EN ISO 14937:2009 (E) 3 Annex

38、 D (normative) Approach 3 Conservative process definition based on inactivation of reference microorganisms. 26 Annex E (informative) Guidance on application of this International Standard 28 Bibliography. 42 Annex ZA (informative) Relationship between this European Standard and the Essential Requir

39、ements of EU Directive 90/385/EEC on Active Implantable Medical Devices . 44 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 45 Annex ZC (informative) Relationship between this European Standard and the Es

40、sential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices. 46 Foreword 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 April 201

41、0, and conflicting national standards shall be withdrawn at the latest by April 2010. 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.

42、This document supersedes EN ISO 14937:2000. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annex ZA, B and C, w

43、hich 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 European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,

44、Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, 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

45、 any modification. DIN EN ISO 14937:2010-03 EN ISO 14937:2009 (E) 4 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” Introduction A ste

46、rile medical device is one that is free of viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a med

47、ical 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) could, prior to sterilization, have microorganisms on them, albeit in low number

48、s. 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. 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