1、Packaging for terminally sterilized medical devicesPart 2: Validation requirements for forming, sealing and assembly processesBS EN ISO 11607-2:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11607-2 July 2017 ICS 11.080.30 Supersedes EN ISO 11607-2:2006English Version Packaging for ter
2、minally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014) Emballages des dispositifs mdicaux striliss au stade terminal - Partie 2: Exigences de validation pour les procds de formage, scellage et assembla
3、ge (ISO 11607-2:2006, y compris Amd 1:2014) Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2006, einschlielich Amd 1:2014) This European Standard was approved by C
4、EN 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 alteration. Up-to-date lists and bibliographical references concerning such national standards
5、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 its own language and notifie
6、d 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, Germany, Greece, Hungary, Icela
7、nd, 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 KOMITEE FR NORMUNG CEN-CENELE
8、C 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 11607-2:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 11607-2:2017. It is identical t
9、o ISO 11607-2:2006, incorporating amendment 1:2014. It supersedes BS EN ISO 11607-2:2006+A1:2014, 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 this c
10、ommittee 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 0 580 96434 3ICS 11.
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.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 11607
12、-2:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11607-2 July 2017 ICS 11.080.30 Supersedes EN ISO 11607-2:2006English Version Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including
13、 Amd 1:2014) Emballages des dispositifs mdicaux striliss au stade terminal - Partie 2: Exigences de validation pour les procds de formage, scellage et assemblage (ISO 11607-2:2006, y compris Amd 1:2014) Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanf
14、orderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2006, 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
15、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 CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official ver
16、sions (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 has the same status as the official versions. CEN members are the national standards bodies of Austria
17、, 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, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain,
18、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-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide fo
19、r CEN national Members. Ref. No. EN ISO 11607-2:2017 EBS EN ISO 11607-2:2017EN ISO 11607-2:2017 (E) 3 European foreword The text of ISO 11607-2:2006, including Amd 1:2014 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for
20、 Standardization (ISO) and has been taken over as EN ISO 11607-2:2017 by Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by
21、 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 possibility that some of the elements of this document may be the subject of patent rights. CEN shall not
22、 be held responsible for identifying any or all such patent rights. This standard replaces EN ISO 11607-2:2006. This document has been prepared under a standardization request given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU D
23、irective(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 for the application of this document. For undated references, the latest edition of the referenced d
24、ocument (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 that any referenced document has not been superseded and that its relevant contents can still be consid
25、ered 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, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE Th
26、e 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 Equivalent dated
27、 standard EN ISO or IEC ISO 11607-1 EN ISO 11607-1:2009/A1: 2014 BS EN ISO 11607-2:2017EN ISO 11607-2:2017 (E) 4 According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgari
28、a, Croatia, Cyprus, Czech Republic, Denmark, Estonia, 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, Switzerlan
29、d, Turkey and the United Kingdom. Endorsement notice The text of ISO 11607-2:2006, including Amd 1:2014 has been approved by CEN as EN ISO 11607-2:2017 without any modification. BS EN ISO 11607-2:2017EN ISO 11607-2:2017 (E) 5 Annex ZA (informative) Relationship between this European Standard and the
30、 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 Standards related to medical devices to provide one voluntary means of conforming to essential
31、 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 implemented as a national standard in at least one Member State, compliance with the normative
32、 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. NOTE 1 Where a reference from a clause of this standard to the risk man
33、agement 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 lowest possible level, minimized or removed, according to the wording of the correspondi
34、ng 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 based on normative references according to the table of references in the European fore
35、word, 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 I of Directive 93/42/EEC OJ L 169 Essential Requirement
36、s of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 8.1 4.3, 5, 6, 7, 8 E.R. 8.1 is covered only in respect of the function of the 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 prese
37、ntation and only if the requirements of EN ISO 11607-1:2009/A1:2014 (Requirements for materials, sterile barrier systems and packaging systems) are met as well. 8.3 4.3, 5, 6, 8 E.R. 8.3 is covered only in BS EN ISO 11607-2:2017EN ISO 11607-2:2017 (E) 6 Essential Requirements of Directive 93/42/EEC
38、Clause(s)/sub-clause(s) of this EN Remarks/Notes 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 of EN ISO 11607-1:2009/A1:2014 are met a
39、s well (Requirements for materials, sterile barrier systems and packaging systems). In this respect damage to the “protective packaging” is taken to mean damage to or loss of integrity of the sterile barrier system only. 8.4 5, 6, 8 E.R. 8.4 is covered only in respect of the compatibility between th
40、e packaging and the selected sterilisation processes including packaging system performance testing and sterile barrier system stability testing, but only if the requirements of EN ISO 11607-1:2009/A1:2014 are met as well (Requirements for materials, sterile barrier systems and packaging systems). W
41、ARNING 1 Presumption of conformity 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 U
42、nion. WARNING 2 Other Union legislation may be applicable to the products falling within the scope of this standard. BS EN ISO 11607-2:2017EN ISO 11607-2:2017 (E) 7 Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC OJ L 189 aime
43、d to be covered This European Standard 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 i
44、mplantable medical devices OJ L 189. 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 t
45、he 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 made, the risk management process needs to be in compliance with Directive 90/385/EEC as amended by 2007/47/EC. This me
46、ans 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 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requiremen
47、ts 1, 4, 5, 8, 9 and 10 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 in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZB.1, it means that it is not addres
48、sed by this European Standard. Table 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 4.3, 5, 6, 8 E.R. 7 is covered only in respect of the function of ste
49、rile 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 of EN ISO 11607-1:2009/A1:2014 are met as well (Requirements for materials, sterile barrier systems and packaging systems). WARNING 1 Presumption of conformity 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 BS EN ISO 1160
