EN ISO 11607-1-2009 en Packaging for terminally sterilized medical devices - Part 1 Requirements for materials sterile barrier systems and packaging systems (Incorporates Amendment.pdf

1、BS EN ISO11607-1:2009ICS 11.080.30NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPackaging forterminally sterilizedmedical devicesPart 1: Requirements for materials, sterile barrier systems and packaging systems BS EN ISO 11607-1:2009 +A1:2014BS EN ISO 11607-1:

2、2009+A1:2014ISBN 978 0 580 77066 1Amendments/corrigenda issued since publicationDate Comments31 August 2014 Implementation of ISO amendment 1:2014 with CEN endorsement A1:2014. Annex ZA amendedThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 2

3、8 February 2010 The British Standards Institution 2014. Published by BSI Standards Limited 2014National forewordThis British Standard is the UK implementation of EN ISO 11607-1:2009+A1:2014. It is identical to ISO 11607-1:2006, incorporating amendment 1:2014. It supersedes BS EN ISO 11607-1:2009 whi

4、ch is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is indicated by .The UK participation in its preparation was entru

5、sted to Technical Committee CH/198, Sterilization of medical devices.A list of organizations represented on this committee can be obtained on request to its secretary.The publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applica

6、tion.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11607-1June 2009ICS 11.080.30 Supersedes EN ISO 11607-1:2006 English VersionPackaging for terminally sterilized medical devices - Part 1:Requirements for materi

7、als, sterile barrier systems andpackaging systems (ISO 11607-1:2006)Emballages des dispositifs mdicaux striliss au stadeterminal - Partie 1: Exigences relatives aux matriaux, auxsystmes de barrire strile et aux systmes demballage(ISO 11607-1:2006)Verpackungen fr in der Endverpackung zu sterilisieren

8、deMedizinprodukte - Teil 1: Anforderungen an Materialien,Sterilbarrieresysteme und Verpackungssysteme (ISO11607-1:2006)This European Standard was approved by CEN on 16 May 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Eu

9、ropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (Englis

10、h, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyp

11、rus, 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, Switzerland and United Kingdom.EUROPEAN COMMITTEE FORSTANDARDIZATIONCOMIT

12、EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FRNORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11607-1:2009: EEN ISO 11607-1:2009+A1July 2014BS EN ISO 11607-1:2009EN

13、 ISO 11607-1:2009 (E)3 Foreword The textofISO 11607-1:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of healthcare products”ofthe International Organizationfor Standardization (ISO)and has been taken over as EN ISO 11607-1:2009 by Technical Committee CEN/TC102 “Sterilizersfo

14、r medical purposes” the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical textorbyendorsement, at the latestbyDecember 2009, and conflicting national standards shall be withdrawn at the latestbyMarch 201

15、0. Attention is drawn to the possibilitythat some of the elements of this document maybethe subject of patent rights.CEN and/or CENELEC shallnot be held responsible for identifying anyorall such patent rights. This document supersedes EN ISO11607-1:2006.This document has been prepared under amandate

16、 given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive.Forrelationship withECDirective, seeinformative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC InternalRegulations, the national s

17、tandardsorganizations of the followingcountriesare bound to implement this European Standard: Austria,Belgium,Bulgaria, Cyprus, CzechRepublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta,Netherlands, Norway,Poland, Portuga

18、l, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the UnitedKingdom. Endorsement noticeThe textofISO 11607-1:2006 has been approved by CEN as a EN ISO 11607-1:2009 without anymodification.BS EN ISO 11607-1:2009EN ISO 11607-1:2009 (E)3 Foreword The textofISO 11607-1:2006 has been prepare

19、d by Technical Committee ISO/TC 198 “Sterilization of healthcare products”ofthe International Organizationfor Standardization (ISO)and has been taken over as EN ISO 11607-1:2009 by Technical Committee CEN/TC102 “Sterilizersfor medical purposes” the secretariat of which is held by DIN.This European S

20、tandard shall be given the status of a national standard, either by publication of an identical textorbyendorsement, at the latestbyDecember 2009, and conflicting national standards shall be withdrawn at the latestbyMarch 2010. Attention is drawn to the possibilitythat some of the elements of this d

21、ocument maybethe subject of patent rights.CEN and/or CENELEC shallnot be held responsible for identifying anyorall such patent rights. This document supersedes EN ISO11607-1:2006.This document has been prepared under amandate given to CEN by the European Commission and the European Free Trade Associ

22、ation, and supports essential requirements of EC Directive.Forrelationship withECDirective, seeinformative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC InternalRegulations, the national standardsorganizations of the followingcountriesare bound to implement this

23、European Standard: Austria,Belgium,Bulgaria, Cyprus, CzechRepublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta,Netherlands, Norway,Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the UnitedKi

24、ngdom. Endorsement noticeThe textofISO 11607-1:2006 has been approved by CEN as a EN ISO 11607-1:2009 without anymodification.BS EN ISO 11607-1:2009EN ISO 11607-1:2009 (E)3 Foreword The textofISO 11607-1:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of healthcare products”o

25、fthe International Organizationfor Standardization (ISO)and has been taken over as EN ISO 11607-1:2009 by Technical Committee CEN/TC102 “Sterilizersfor medical purposes” the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publica

26、tion of an identical textorbyendorsement, at the latestbyDecember 2009, and conflicting national standards shall be withdrawn at the latestbyMarch 2010. Attention is drawn to the possibilitythat some of the elements of this document maybethe subject of patent rights.CEN and/or CENELEC shallnot be he

27、ld responsible for identifying anyorall such patent rights. This document supersedes EN ISO11607-1:2006.This document has been prepared under amandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive.Forrelationship

28、withECDirective, seeinformative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC InternalRegulations, the national standardsorganizations of the followingcountriesare bound to implement this European Standard: Austria,Belgium,Bulgaria, Cyprus, CzechRepublic, Denmark

29、, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta,Netherlands, Norway,Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the UnitedKingdom. Endorsement noticeThe textofISO 11607-1:2006 has been approved by CE

30、N as a EN ISO 11607-1:2009 without anymodification.iiBS EN ISO 11607-1:2009+A1:2014EN ISO 11607-1:2009+A1:2014 (E)EN ISO 11607-1:2009/A1:2014 (E) 3 Foreword This document (EN ISO 11607-1:2009/A1:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in coll

31、aboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 11607-1:2009 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the

32、 latest by January 2015, and conflicting national standards shall be withdrawn at the latest by January 2015. 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

33、all such patent rights. 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 Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part

34、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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Mace

35、donia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11607-1:2006/Amd 1:2014 has been a

36、pproved by CEN as EN ISO 11607-1:2009/A1:2014 without any modification. Foreword to amendment A1iiiBS EN ISO 11607-1:2009+A1:2014EN ISO 11607-1:2009+A1:2014 (E)EN ISO 11607-1:2009/A1:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Di

37、rective 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/EEC on medical devices. Once th

38、is 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 ZA.1 confers, within the limits of the scope of this standard, a presumpti

39、on of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this International Standard and Directive 93/42/EEC on medical devices Clause(s)/subclause(s) of this International standard Essential Requirements (ERs

40、) of EU Directive 93/42/EEC Qualifying remarks/notes 5.1.3, 5.1.4, 5.1.5, 5.5 7.2 5.1.6 e), 5.1.7 a), 5.1.7 d), 5.1.7 f), 5.1.7 g), 5.1.9 a), 5.3.1, 6.1.3, 6.2.3, 7.3, 1st part 5.1.7 a), 5.1.7 g), 5.1.9 a), 5.4 c) 7.5, 1st paragraph 5.1.7 g) 7.5, 2nd paragraph Partly addressed. Only toxics are dealt

41、 with. 5.1.6 a), 5.1.10 b) 5.1.10 c), 5.2, 6.1.1, 6.1.2, 6.1.4 7.6 Partly addressed. To fully address the ER, validation requirements for forming, sealing and assembling processes need to be addressed (ISO 11607-2). 5.1.6 a), 5.1.10 b), 5.1.10 c), 5.2, 6.1.1, 6.1.2, 6.1.4, 6.2.2, 6.3.5 8.1 Partly ad

42、dressed. To fully address the ER, validation requirements for forming, sealing and assembling processes need to be addressed (ISO 11607-2). 5.1.10 a), 5.1.10 b), 5.1.10 c), 6.1.1, 6.1.2, 6.1.4, 6.2.2, 6.3.1, 6.3.5, 6.4.1, 7.1 8.3 Partly addressed. To fully address the ER, validation requirements for

43、 forming, sealing and assembling processes need to be addressed (ISO 11607-2). 5.1.3, 5.1.4, 5.1.5, 5.1.7 d) 8.5 ivBS EN ISO 11607-1:2009+A1:2014EN ISO 11607-1:2009+A1:2014 (E)EN ISO 11607-1:2009/A1:2014 (E) 5 5.1.3, 5.1.4, 5.1.5, 7.1, 5.1.6 e), 5.1.7 f), 5.1.7 g), 5.1.9 a), 5.3, 6.1.3 8.6 5.3.6, 7.

44、1 9.1 Partly addressed. To fully address the ER, validation requirements for forming, sealing and assembling processes need to be addressed (ISO 11607-2). 6.2.3 h), 6.2.3 j), 7.1 9.2, 2nd dash Partly addressed. Standard does not mention or define values and/or limits. 7 13.1 Partly addressed. Traini

45、ng and knowledge of the potential users is not dealt with. 7 13.3 a), b), d), e), f), i), j), m) 5.1.10 d), 5.1.11 b), 5.1.12 13.6 h) Partly addressed. Standard requires this information only for reusable SBS. BS EN ISO 11607-1:2009ISO 11607-1:2006(E) ISO 2006 All rightsreserved iiiContents PageFore

46、word ivIntroduction v1Scope . 12Normative references. 13Terms and definitions. 14General requirements. 54.1 General. 54.2 Quality systems 54.3 Sampling64.4 Test methods. 64.5 Documentation 65Materials and preformed sterile barrier systems 75.1 General requirements. 75.2 Microbial barrier properties.

47、 95.3 Compatibility with the sterilization process. 105.4 Compatibility with thelabelling system . 105.5 Storage and transport 106Design and development requirements for packaging systems. 116.1 General. 116.2 Design 116.3 Packaging-system performance testing. 126.4 Stabilitytesting.127Information t

48、o be provided 13AnnexA(informative) Guidance on medical packaging 14AnnexB(informative) Standardizedtest methods and proceduresthatmay be used to demonstrate compliance with the requirements of this part of ISO11607 17AnnexC(normative) Test method for resistance of impermeable materialstothe passage

49、 of air 21Bibliography. 22 ISO 2006 All rights reservedBS EN ISO 11607-1:2009+A1:2014ISO 11607-1:2006+A1:2014 (E)vviviiBS EN ISO 11607-1:2009ISO 11607-1:2006(E)iv ISO 2006 All rightsreservedForeword ISO (the International Organization forStandardization)isa worldwide federation of national standards bodies (ISO member bodies). The workofpreparing International Standards is normallycarriedout through ISO technical committees. Eachmember bodyinterestedin a subject forwhich a technical committee has beenestablished hasthe right to be represented on th