1、BRITISH STANDARDBS EN ISO 11607-2:2006Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processesThe European Standard EN ISO 11607-2:2006 has the status of a British StandardICS 11.080.30g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g
2、50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO +A1:2014BS EN ISO 11607-2:2006+A1:2014ISBN 978 0 580 77067 8Amendments/corrigenda issued since publicationDate Comments30 September 20
3、14 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 31 May 2006 The British Standards Institution 2014. Published by BSI Standards Limited 2014National forewo
4、rdThis British Standard is the UK implementation of EN ISO 11607-2:2006+A1:2014. It is identical to ISO 11607-2:2006, incorporating amendment 1:2014. It supersedes BS EN ISO 11607-2:2006, which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by t
5、ags. 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 entrusted to Technical Committee CH/198, Sterilization of medical devices.A list of organizations represented on t
6、his 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 application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARDNORME
7、EUROPENNEEUROPISCHE NORMEN ISO 11607-2April 2006ICS 11.080.30English VersionPackaging for terminally sterilized medical devices - Part 2:Validation requirements for forming, sealing and assemblyprocesses (ISO 11607-2:2006)Emballages des dispositifs mdicaux striliss au stadeterminal - Partie 2: Exige
8、nces de validation pour lesprocds de formage, scellage et assemblage (ISO 11607-2:2006)Verpackungen fr in der Endverpackung zu sterilisierendeMedizinprodukte - Teil 2: Validierungsanforderungen anProzesse der Formgebung, Siegelung und desZusammenstellens (ISO 11607-2:2006)This European Standard was
9、approved by CEN on 13 April 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationa
10、lstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified
11、 to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, N
12、orway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form
13、and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11607-2:2006: EEN ISO 11607-2:2006+A1July 2014Foreword This document (EN ISO 11607-2:2006) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Committee
14、 CEN/TC 102 “Sterilizers for 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 text or by endorsement, at the latest by October 2006, and conflicting national standards shall be w
15、ithdrawn at the latest by October 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 requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is a
16、n integral part 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, I
17、celand, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 11607-2:2006 has been approved by CEN as EN ISO 11607-2:2006 without any modifications.
18、EN ISO 11607-2:2006iiBS EN ISO 11607-2:2006+A1:2014EN ISO 11607-2:2006+A1:2014 (E)EN ISO 11607-2:2006/A1:2014 (E) 3 Foreword This document (EN ISO 11607-2:2006/A1:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committ
19、ee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 11607:2006 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2015, and confl
20、icting 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 all such patent rights. This docum
21、ent 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 of this document. According to the
22、 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 Macedonia, France, Germany, Greece, Hu
23、ngary, 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 11607-2:2006/Amd 1:2014 has been approved by CEN as EN ISO 11607-2:2
24、006/A1:2014 without any modification. Foreword to amendment A1Endorsement noticeiiiBS EN ISO 11607-2:2006+A1:2014EN ISO 11607-2:2006+A1:2014 (E)EN ISO 11607-2:2006/A1:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EE
25、C 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 this standard is c
26、ited 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 presumption of conformity
27、 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 device Clause(s)/subclause(s) of this International standard Essential Requirements (ERs) of EU Directive
28、 93/42/EEC Qualifying remarks/notes 4.1, 4.3, 5, 6, 7, 8 7.6 Partly addressed. To fully address the ER, requirements for materials, sterile barrier systems and packaging systems need to be addressed (ISO 11607-1). 4.1, 4.3, 5, 6, 7, 8 8.1, 8.3 Partly addressed. To fully address the ER, requirements
29、for materials, sterile barrier systems and packaging systems need to be addressed (ISO 11607-1). 5 8.4 6.1 8.5 Partly addressed. Standard does not mention or define values and/or limits. 6.3 8.6, 2nd part Partly addressed. To fully address the ER, requirements for materials, sterile barrier systems
30、and packaging systems need to be addressed (ISO 11607-1). iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 General requirements. 4 4.1 Quality systems 4 4.2 Sampling 4 4.3 Test methods. 4 4.4 Documentation 5 5 Validation of packaging pro
31、cesses. 5 5.1 General. 5 5.2 Installation qualification (IQ) . 6 5.3 Operational qualification (OQ). 6 5.4 Performance qualification (PQ) . 7 5.5 Formal approval of the process validation 8 5.6 Process control and monitoring . 8 5.7 Process changes and revalidation 8 6 Packaging system assembly . 8
32、7 Use of reusable sterile barrier systems 9 8 Sterile fluid-path packaging. 9 Annex A (informative) Process development 10 Bibliography . 11 EN ISO 11607-2:2006Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC on medical
33、devices 12 iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions 14 General requirements. 4 4.1 Quality systems 4 4.2 Sampling 4 4.3 Test methods 44.4 Documentation5 Validation of packaging processes. 5 5.1 General. 5 5.2 Installation qualificatio
34、n (IQ) . 6 5.3 Operational qualification (OQ). 6 5.4 Performance qualification (PQ) . 7 5.5 Formal approval of the process validation 8 5.6 Process control and monitoring5.7 Process changes and revalidation 8 6 Packaging system assembly . 8 7 Use of reusable sterile barrier systems 9 8 Sterile fluid
35、-path packaging. 9 Annex A (informative) Process development . 10Bibliography . 11 EN ISO 11607-2:2006Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 12 BS EN ISO 11607-2:2006+A1:2014ISO 11607-2:2006+
36、A1:2014ivviiv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject
37、 for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC)
38、on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees
39、 are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be hel
40、d responsible for identifying any or all such patent rights. ISO 11607-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 11607-1 and ISO 11607-2 cancel and replace ISO 11607:2003, which has been technically revised. ISO 11607 consists of the following parts
41、, under the general title Packaging for terminally sterilized medical devices: Part 1: Requirements for materials, sterile barrier systems and packaging systems Part 2: Validation requirements for forming, sealing and assembly processes EN ISO 11607-2:2006BS EN ISO 11607-2:2006+A1:2014ISO 11607-2:20
42、06+A1:2014v vIntroduction Medical devices delivered in a sterile state should be designed, manufactured and packed to ensure that they are sterile when placed on the market and remain sterile, under documented storage and transport conditions, until the sterile barrier system is damaged or opened. A
43、dditionally, medical devices delivered in a sterile state should have been manufactured and sterilized by an appropriate, validated method. One of the most critical characteristics of a sterile barrier system and packaging system for sterile medical devices is the assurance of sterility maintenance.
44、 The development and validation of packaging processes are crucial to ensure that sterile barrier system integrity is attained and will remain so until opened by the users of sterile medical devices. There should be a documented process validation program demonstrating the efficacy and reproducibili
45、ty of all sterilization and packaging processes. Along with the sterilization process, some of the packaging operations that can affect sterile barrier system integrity are forming, sealing, capping or other closure systems, cutting and process handling. This part of ISO 11607 provides the framework
46、 of activities and requirements to develop and validate the process used to make and assemble the packaging system. ISO 11607-1 and ISO 11607-2 are designed to meet the Essential Requirements of the European Medical Device Directives. One significant barrier to harmonization was terminology. The ter
47、ms “package”, “final package”, “final pack”, “primary pack”, and “primary package” all have different connotations around the globe and choosing one of these terms to be the harmonized basis for this part of ISO 11607 was considered a barrier to successful completion of this document. As a result, t
48、he term “sterile barrier system” was introduced to describe the minimum packaging required to perform the unique functions required of medical packaging: to allow sterilization, to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects the ste
49、rile barrier system, and together they form the packaging system. “Preformed sterile barrier systems” would include any partially assembled sterile barrier systems such as pouches, header bags or hospital packaging reels. The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices. Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device. Preformed sterile
