1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 13408-6:2011Aseptic processing of health care productsPart 6: Isolator systems+A1:2013BS EN ISO 13408-6:2011+A1:2013National forewordThis British Standard is the UK imp
2、lementation of EN ISO 13408-6:2011+A1:2013. It is identical to ISO 13408-6:2005, incorporating amendment 1:2013. It supersedes BS EN ISO 13408-6:2011, which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags.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 t
3、ext 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 this committee can be obtained on re
4、quest 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 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 76266 6ICS 11.080.01Compliance with a Briti
5、sh Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 October 2011.Amendments/corrigenda issued since publicationDate Text affected30 June 2013 Implementation of ISO amendment 1:2013 with
6、 CEN endorsement A1:2013. Annexes ZA, ZB and ZC updatedBRITISH STANDARDEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13408-6:2011+A1 March 2013 ICS 11.080.01 English Version Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005) Traitement aseptique des p
7、roduits de sant - Partie 6: Systmes isolateurs (ISO 13408-6:2005) Aseptische Herstellung von Produkten fr die Gesundheitsfrsorge - Teil 6: Isolatorensysteme (ISO 13408-6:2005) This European Standard was approved by CEN on 10 June 2011. CEN members are bound to comply with the CEN/CENELEC Internal Re
8、gulations 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 CEN-CENELEC Management Centre or to any CEN me
9、mber. 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 has the same status as the official versions.
10、 CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Sloveni
11、a, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN nati
12、onal Members. Ref. No. EN ISO 13408-6:2011: E3 Foreword The text of ISO 13408-6:2005 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 13408-6:2011 by Technical Com
13、mittee CEN/TC 204 “Sterilization of medical devices” the secretariat of which is held by BSI. 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 December 2011, and conflicting national standards shal
14、l be withdrawn at the latest by December 2011. 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 document supersedes EN 13824:2004.
15、 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 Directives. For relationship with EU Directives, see informative Annexes ZA, ZB, or ZC, which are integral parts of this documen
16、t. 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, France, Germany, Greece, Hungary, Iceland, Irel
17、and, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 13408-6:2005 has been approved by CEN as a EN ISO 13408-6:2011 without any modification. Forewor
18、d to amendment A1This document (EN ISO 13408-6:2011/A1:2013) has been pr epared 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 Amendment to
19、 the European Standard EN ISO 13408:2011 shall be given the status of a na tional standard, either by publication of an identical text or by endorsement, at the latest by September 2013, and conflicting national standards shall be withdrawn at the latest by September 2013. Attention is drawn to the
20、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 document has been prepared under a mandate given to CEN by the European Commission and the European Free Tr
21、ade Association, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annex ZA, B, C, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries a
22、re 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, Norway, Poland, P
23、ortugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement noticeThe text of ISO 13408-6:2005/Amd 1:2013 has been approved by CEN as EN ISO 13408-6:2011/A1:2013 without any modification.BS EN ISO 13408-6:2011+A1:2013 ISO 13408-6:2011+A1:2013 (E)4 BS
24、EN ISO 13408-6:2011+A1:2013 ISO 13408-6:2011+A1:2013 (E)Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices This European Standard has been prepared under a mandate given to CEN by the Euro
25、pean Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has be
26、en 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 with the corresponding Essential Requirements of that Directive and associated EF
27、TA regulations. Table ZA.1 Correspondence between this European Standard and Directive 90/385/EEC Clauses of this EN Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10 7 In conjunction with EN ISO 13408-1, this relevant Essential Requirement is only partly a
28、ddressed in this International Standard. Packaging for maintenance of sterility during transportation and storage are not covered WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. 5 BS EN ISO 13408-6:2011+A1:2013 ISO 134
29、08-6:2011+A1:2013 (E)Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 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
30、 to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. 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, complia
31、nce with the 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 Requirements of that Directive and associated EFTA regulations. Table ZB.1 Correspondence between this European Standard an
32、d Directive 93/42/EEC Clauses of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10 8.3 In conjunction with EN ISO 13408-1, this relevant Essential Requirement is only partly addressed in this International Standard. Packaging for maintenance of steri
33、lity during transportation and storage are not covered 4,5,6,7,8,9,10 8.4 This relevant Essential Requirement is addressed in this International standard only in conjunction with ISO 13408-1 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the sco
34、pe of this Standard. 6 BS EN ISO 13408-6:2011+A1:2013 ISO 13408-6:2011+A1:2013 (E)Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices This European Standard has been prepared under a mandate
35、 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 98/79/EC on in vitro diagnostic medical devices. Once this standard is cited in the Official Journal of the European Union under t
36、hat 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 ZC.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Dir
37、ective and associated EFTA regulations. Table ZC.1 Correspondence between this European Standard and Directive 98/79/EC Clauses of this EN Essential Requirements (ERs) of Directive 98/79/EC Qualifying remarks/Notes 4,5,6,7,8,9,10 B.2.3 In conjunction with EN ISO 13408-1, this relevant Essential Requ
38、irement is only partly addressed in this International Standard. Packaging for maintenance of sterility during transportation and storage are not covered 4,5,6,7,8,9,10 B.2.4 This relevant Essential Requirement is addressed in this International standard only in conjunction with ISO 13408-1 WARNING
39、Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. ISO 2013 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Quality system elements 2 4.1 General
40、. 2 4.2 Management responsibility . 3 4.3 Design control. 3 4.4 Measuring instruments and measuring systems 3 5 Design of isolator systems 3 5.1 General. 3 5.2 Types of isolators . 3 5.3 Materials of construction . 4 5.4 Air-handling system . 4 5.5 Operator interface. 5 5.6 Ancillary equipment 5 6 F
41、acility requirements 6 6.1 Surrounding room classification 6 6.2 Process utilities 6 7 User requirements 6 7.1 Product/process application . 6 7.2 Ergonomics . 6 7.3 Cleaning. 7 7.4 Bio-decontamination 7 8 Validation. 10 8.1 General. 10 8.2 Design qualification 10 8.3 Installation qualification. 10
42、8.4 Operational qualification 11 8.5 Performance qualification 12 8.6 Review and approval of validation 13 8.7 Requalification 13 9 Routine monitoring and control 14 9.1 Procedures 14 9.2 System integrity 14 9.3 Bio-decontamination process monitoring . 14 9.4 Environmental monitoring . 14 9.5 Change
43、 control 14 9.6 Maintenance and calibration . 15 10 Personnel training 15 Bibliography . 16 BS EN ISO 13408-6:2011+A1:2013 ISO 13408-6:2011+A1:2013 (E)iv ISO 2013 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodi
44、es (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations
45、, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the IS
46、O/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the
47、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 held responsible for identifying any or all such patent rights. ISO 13408-6 was prepared by Technical Committee ISO/TC 198, Sterilizati
48、on of health care products. ISO 13408 consists of the following parts, under the general title Aseptic processing of health care products: Part 1: General requirements Part 2: Filtration Part 3: Lyophilization Part 4: Clean-in-place technologies Part 5: Sterilization in place Part 6: Isolator system
49、s Part 7: Alternative processes for medical devices and combination products ! “BS EN ISO 13408-6:2011+A1:2013 ISO 13408-6:2011+A1:2013 (E) ISO 2013 All rights reserved vIntroduction Health care products that are labelled “sterile” are prepared by using appropriate and validated methods. When a health care product is intended to be sterile and cannot be terminally sterilized, aseptic processing provides an alternative. This applies to the aseptic preparation and filling of solutions, suspensions, emulsions, and solids, as well as to the ase
