EN ISO 11737-1-2018 en Sterilization of health care products - Microbiological methods - Part 1 Determination of a population of microorganisms on products.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Sterilization of health care products - Microbiological methodsPart 1: Determination of a population of microorganisms on productsBS EN ISO 11737-1:2018Incorporating corrigendum June 2018EUROPEAN STANDARD NORME EUROPENN

2、E EUROPISCHE NORM EN ISO 11737-1 January 2018 ICS 07.100.10; 11.080.01 Supersedes EN ISO 11737-1:2006English Version Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) Strilisation des produits de s

3、ant - Mthodes microbiologiques - Partie 1: Dtermination dune population de micro-organismes sur des produits (ISO 11737-1:2018) Sterilisation von Produkten fr die Gesundheitsfrsorge - Mikrobiologische Verfahren - Teil 1: Bestimmung der Population von Mikroorganismen auf Produkten (ISO 11737-1:2018)T

4、his European Standard was approved by CEN on 6 December 2017. 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 standard without any alteration. Up-to-date lists and bibliographical refe

5、rences 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 any other language made by translation under the responsibility of a CE

6、N 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 Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedoni

7、a, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION

8、 EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11737-1:2018 ENational forewordThis British Standard is the UK implementa

9、tion of EN ISO 11737-1:2018. It is identical to ISO 11737-1:2018. It supersedes BS EN ISO 11737-1:2006, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of organizations represented on

10、this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 539 01414 3I

11、CS 07.100.10; 11.080.01Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affected31 May 2018 Im

12、plementation of CEN correction notice 14 March 2018: European Foreword has been updated and Annexes ZA, ZB and ZC have been added30 June 2018 Implementation of CEN correction notice 18 April 2018: Z Annexes updatedBRITISH STANDARDBS EN ISO 11737-1:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NOR

13、M EN ISO 11737-1 January 2018 ICS 07.100.10; 11.080.01 Supersedes EN ISO 11737-1:2006English Version Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) Strilisation des produits de sant - Mthodes mi

14、crobiologiques - Partie 1: Dtermination dune population de micro-organismes sur des produits (ISO 11737-1:2018) Sterilisation von Produkten fr die Gesundheitsfrsorge - Mikrobiologische Verfahren - Teil 1: Bestimmung der Population von Mikroorganismen auf Produkten (ISO 11737-1:2018)This European Sta

15、ndard was approved by CEN on 6 December 2017. 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 standard without any alteration. Up-to-date lists and bibliographical references concernin

16、g 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 any other language made by translation under the responsibility of a CEN member into it

17、s 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 Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germa

18、ny, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOM

19、ITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11737-1:2018 EBS EN ISO 11737-1:2018EN ISO 11737-1:2018 (E) 3 European foreword This docu

20、ment (EN ISO 11737-1:2018) 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

21、a national standard, either by publication of an identical text or by endorsement, at the latest by July 2018, and conflicting national standards shall be withdrawn at the latest by July 2018. Attention is drawn to the possibility that some of the elements of this document may be the subject of pate

22、nt rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11737-1:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requiremen

23、ts of EU Directive. For relationship with EU Directive(s), see informative Annex ZA, ZB, and ZC, which are integral parts of this document. The following referenced documents are indispensable for the application of this document. For undated references, the edition of the referenced document (inclu

24、ding 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 superseded and that its relevant contents can still

25、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 version of the ISO or IEC standard as listed below

26、. NOTE 1 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 as listed in Clause 2 of the ISO standard Equiv

27、alent dated standard EN ISO ISO 10012 EN ISO 10012:2003 ISO 10012:2003 ISO 13485 EN ISO 13485:2016 ISO 13485:2016 ISO 15189 EN ISO 15189:2012 ISO 15189:2012 ISO/IEC 17025 EN ISO/IEC 17025:2017 ISO/IEC 17025:2017 NOTE 2 Many of the standards normatively referred to by ISO 11737-1 are undated. These r

28、eferred standards also include normative references themselves to other dated and undated standards. For undated normative references, it should always be assumed that the latest edition applies. BS EN ISO 11737-1:2018EN ISO 11737-1:2018 (E) 4 According to the CEN-CENELEC Internal Regulations, the n

29、ational 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,

30、Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11737-1:2018 has been approved by CEN as EN ISO 11737-1:2018 without any modification. BS EN ISO 117

31、37-1:2018EN ISO 11737-1:2018 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices OJ L 189 aimed to be covered This European standard has been prepared under a Commissions standardisat

32、ion request M/023 to provide one voluntary means of conforming to essential requirements of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices OJ L 189. Once this standard is cited in the Official Journal

33、of the European Union under that Directive, compliance with the normative 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

34、. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with 90/385/EEC, as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level,

35、minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with essential requirements 1, 4, 5, 8, 9 and 10 of the Directive. NOTE 3 This Annex ZA is based on normative references ac

36、cording to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Annex

37、I of Directive 90/385/EEC OJ L 189 Essential Requirements (ERs) of Directive 90/385/EEC Clauses of this EN Qualifying remarks/Notes 7 4,5,6,7,8,9 This standard addresses the determination of the population of microorganisms on or in a medical device as part of the validation and routine control of a

38、 sterilization process. This relevant Essential Requirement is partly addressed in this European Standard and only in conjunction with the applicable standard for validation and routine control of the sterilization process being employed. Design and packaging for maintenance of sterility during tran

39、sportation and storage are not covered. Aspects of manufacture other than those related to sterilization are not covered. BS EN ISO 11737-1:2018EN ISO 11737-1:2018 (E) 6 WARNING 1 Presumption of conformity stays valid only as long as a reference to this European Standard is maintained in the list pu

40、blished in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2 Other Union legislation may be applicable to the products falling within the scope of this standard. BS EN ISO 11

41、737-1:2018EN ISO 11737-1:2018 (E) 7 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/023 t

42、o provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this stan

43、dard 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. NOTE 1 Where a reference from a clause of this standard to the risk management process is ma

44、de, the risk management process needs to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE

45、 2 The manufacturers policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZB is based on normative references according to the table of references in the European foreword, replacing the references

46、 in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this European Standard. Table ZB.1 Correspondence between this European Standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements (ERs) of Directive 93/42/EEC

47、 Clauses of this EN Qualifying remarks/Notes 8.3 4,5,6,7,8,9 This standard addresses the determination of the population of microorganisms on or in a medical device as part of the validation and routine control of a sterilization process. This relevant Essential Requirement is partly addressed in th

48、is European Standard and only in conjunction with the applicable standard for validation and routine control of the sterilization process being employed. Design and packaging for maintenance of sterility during transportation and storage are not covered. Aspects of manufacture other than those relat

49、ed to sterilization are not covered. BS EN ISO 11737-1:2018EN ISO 11737-1:2018 (E) 8 Essential Requirements (ERs) of Directive 93/42/EEC Clauses of this EN Qualifying remarks/Notes 8.4 4,5,6,7,8,9 This relevant Essential Requirement is only partly addressed in this European Standard. Aspects of manufacture other than those related to determination of the population of microorganisms are not covered. WARNING 1 Presumption of conformity stays valid only as long as a reference to this European Standard is maintained