EN ISO 11607-1-2017 en Packaging for terminally sterilized medical devices - Part 1 Requirements for materials sterile barrier systems and packaging systems.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Packaging for terminally sterilized medical devicesPart 1: Requirements for materials, sterile barrier systems and packaging systemsBS EN ISO 11607-1:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11607-1

2、July 2017 ICS 11.080.30 Supersedes EN ISO 11607-1:2009English Version Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014) Emballages des dispositifs mdicaux striliss au stade

3、terminal - Partie 1: Exigences relatives aux matriaux, aux systmes de barrire strile et aux systmes demballage (ISO 11607-1:2006, y compris Amd 1:2014) Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackung

4、ssysteme (ISO 11607-1:2006, einschlielich Amd 1:2014) This European Standard was approved by CEN on 18 July 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 a

5、lteration. 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 any other language

6、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 Republic, Denmark, Es

7、tonia, Finland, Former Yugoslav Republic of Macedonia, 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 COMMITTE

8、E FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11607-1:2017 ENational fo

9、rewordThis British Standard is the UK implementation of EN ISO 11607-1:2017. It is identical to ISO 11607-1:2006, incorporating amendment 1:2014. It supersedes BS EN ISO 11607-1:2009+A1:2014, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Ster

10、ilization and Associated Equipment and Processes.A list of organizations represented on 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 S

11、tandards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 96433 6ICS 11.080.30Compliance 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.A

12、mendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 11607-1:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11607-1 July 2017 ICS 11.080.30 Supersedes EN ISO 11607-1:2009English Version Packaging for terminally sterilized medical devices - Part 1: Re

13、quirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014) Emballages des dispositifs mdicaux striliss au stade terminal - Partie 1: Exigences relatives aux matriaux, aux systmes de barrire strile et aux systmes demballage (ISO 11607-1:2006, y co

14、mpris Amd 1:2014) Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2006, einschlielich Amd 1:2014) This European Standard was approved by CEN on 18 July 2017. CEN members are boun

15、d 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 concerning such national standards may be obtained on application to the CE

16、N-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 its own language and notified to the CEN-CENELEC Management Centre h

17、as 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, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, L

18、uxembourg, 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 KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B

19、-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11607-1:2017 EBS EN ISO 11607-1:2017EN ISO 11607-1:2017 (E) 3 European foreword The text of ISO 11607-1:2006, including Amd 1:2014 has been prepared by Technic

20、al Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 11607-1:2017 by Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices” the secretariat of whi

21、ch is held by DIN. 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 January 2018, and conflicting national standards shall be withdrawn at the latest by January 2018. Attention is drawn to the poss

22、ibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This standard replaces EN ISO 11607-1:2009. This document has been prepared under a standardization request given to CEN by the Eur

23、opean Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, Annex ZB, and Annex ZC, which are an integral part of this document. The following referenced documents are indispensable

24、 for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check th

25、at any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard,

26、if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE 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

27、 EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 5636-5 ISO 5636-5:2013 BS EN ISO 11607-1:2017EN ISO 11607-1:2017 (E) 4 According to the CEN-CENELEC Internal Regulations, the national standards organizations of the follo

28、wing 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, Lithuania, Luxembourg, Malta, Netherlands, N

29、orway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11607-1:2006, including Amd 1:2014 has been approved by CEN as EN ISO 11607-1:2017 without any modification. BS EN ISO 11607-1:2017EN ISO 11607-

30、1:2017 (E) 5 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/023 concerning the development of European standar

31、ds relating to medical devices to 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 and has been implem

32、ented as a national standard in at least one Member State, 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 E

33、FTA regulations. 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 Directive 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

34、lowest possible level, 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, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is

35、 based on normative references according 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

36、this European Standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 8.1 6.1.1, 6.1.2, 6.1.4, 6.2.2 E.R. 8.1 is covered only in respect of the function of the sterile barrier system(s) to protect the sterili

37、ty of the device from the point of sterilisation to the point of use and to allow for aseptic presentation but only if the requirements of EN ISO 11607-2:2006/A1:2014 are met as well (Validation requirements for forming, sealing and assembling processes) 8.3 4.4, 5.2, 6.1.2, 6.1.4, 6.1.6, 6.2.2, E.R

38、. 8.3 is covered only in BS EN ISO 11607-1:2017EN ISO 11607-1:2017 (E) 6 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 6.3.1, 6.3.4, 6.3.5, 6.4.1, 6.4.2, 6.4.3, 6.4.6, 6.4.7 respect of the function of sterile barrier system(s) to protect the sterility

39、 of the device from the point of sterilisation to the point of use and to allow for aseptic presentation but only if the requirements of EN ISO 11607-2:2006/A1:2014 are met as well (Validation requirements for forming, sealing and assembling processes) In this respect damage to the “protective packa

40、ging” is taken to mean damage to or loss of integrity of the sterile barrier system only. 8.4 4.4, 5.3.1, 5.3.3, 5.3.5, 6.1.2, 6.1.4, 6.1.6, 6.2.2, 6.3.1, 6.3.4, 6.3.5, 6.4.1, 6.4.2, 6.4.3, 6.4.6, 6.4.7 E.R. 8.4 is covered only in respect of the compatibility between the packaging and the selected s

41、terilisation processes including packaging system performance testing and sterile barrier system stability testing, but only if the requirements of EN ISO 11607-2:2006/A1:2014 are met as well (Validation requirements for forming, sealing and assembling processes) WARNING 1 Presumption of conformity

42、stays valid only as long as a reference to this European Standard is maintained in the list published 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 legisla

43、tion may be applicable to the products falling within the scope of this standard. BS EN ISO 11607-1:2017EN ISO 11607-1:2017 (E) 7 Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC OJ L 189 aimed to be covered This European Stand

44、ard has been prepared under a Commissions standardization request M/432 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

45、. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative 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 requirem

46、ents of that Directive and associated EFTA regulations. 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 Directive 90/385/EEC as amended by 2007/47/EC. This means that risks have to be reduced a

47、s far as possible, to a minimum, to the lowest possible level, 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 Dire

48、ctive. NOTE 3 This Annex ZB is based on normative references according 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 ZB.1, it means that it is not addressed by this European Standard. Tabl

49、e ZB.1 Correspondence between this European Standard and Annex I of Directive 90/385/EEC OJ L 189 Essential Requirements of Directive 90/385/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7 6.1.4, 6.1.6, 6.2.2, 6.3.1, 6.3.4, 6.3.5, 6.4.1, 6.4.2, 6.4.3, 6.4.6, 6.4.7 E.R. 7 is covered only in respect of the function of sterile barrier system(s) to protect the sterility of the device from the point of sterilisation to the point of use and to allow for aseptic presentation but only if the requirements o