1、BSI Standards PublicationBS EN ISO 13408-7:2015Aseptic processing of healthcare productsPart 7: Alternative processes for medicaldevices and combination productsBS EN ISO 13408-7:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 13408-7:2015. The UK parti
2、cipation in its preparation was entrusted to TechnicalCommittee CH/198, Sterilization and Associated Equipment andProcesses.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
3、 contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 84747 9 ICS 11.080.01 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under
4、 the authority of the Standards Policy and Strategy Committee on 28 February 2013.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e d31 August 2015 This corrigendum renumbers BS ISO 13408-7:2012as BS EN ISO 13408-7:2015. Z Annexes includedIt is identical to ISO 13408-7:2012. I
5、t supersedes BS ISO 13408-7:2012,which is withdrawn.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13408-7 August 2015 ICS 11.080.01 English Version Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) Tr
6、aitement aseptique des produits de sant - Partie 7: Procds alternatifs pour les dispositifs mdicaux et les produits de combinaison (ISO 13408-7:2012) Aseptische Herstellung von Produkten fr die Gesundheitsfrsorge - Teil 7: Alternative Verfahren fr Medizinprodukte und Kombinationsprodukte (ISO 13408-
7、7:2012) This European Standard was approved by CEN on 30 July 2015. 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 bibliographica
8、l 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 made by translation under the responsibility o
9、f 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, Estonia, Finland, Former Yugoslav Republic of Ma
10、cedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION E
11、UROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13408-7:2015 EEN ISO 13408-7:2015 (E) European foreword The text of ISO 13408-7
12、:2012 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 13408-7:2015 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of which i
13、s 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 February 2016, and conflicting national standards shall be withdrawn at the latest by February 2016. Attention is drawn to the possib
14、ility 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 Trade As
15、sociation, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are integral parts of this document. The following referenced documents are indispensable for the application of this document. For undated references, t
16、he edition of the referenced document (including any amendments) listed below applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, ZB or ZC, the user should always check that any referenced document has not been supersed
17、ed 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 should be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated versio
18、n 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 EN and ISO standards Normative references as li
19、sted in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 13408-1:2008 EN ISO 13408-1:2015 ISO 13408-1:2008 According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgi
20、um, 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, Slovakia, Slovenia, Spain, Sweden, Switzer
21、land, Turkey and the United Kingdom. Endorsement notice The text of ISO 13408-7:2012 has been approved by CEN as EN ISO 13408-7:2015 without any modification. BS EN ISO 13408-7:20154EN ISO 13408-7:2015 (E) Annex ZA (informative) Relationship between this European Standard and the Essential Requireme
22、nts 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 European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 90/38
23、5/EEC on active implantable 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, compliance with the normative clauses of this standard given in Table ZA.1 confers
24、, 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 management process is made, the risk management process
25、needs to be in compliance with 90/385/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 corresponding essential requirement. NOTE 2 The manufacturers policy for
26、 determining acceptable risk must be in compliance with essential requirements 1, 4, 5, 8, 9 and 10 of the Directive. NOTE 3 This Annex ZA 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 Essenti
27、al 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 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
28、,11 7 Only attainment of sterility by aseptic processing is considered by this standard. This relevant Essential Requirement is only partly addressed in this European Standard. Design and packaging for maintenance of sterility during transportation and storage are not covered. Aspects of manufacture
29、 other than those related to aseptic processing are not covered. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. BS EN ISO 13408-7:20155Annex ZB (informative) Relationship between this European Standard and the Essenti
30、al 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 to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on
31、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, compliance with the normative clauses of this standard given in Table ZB.1 confers, within the limits of the s
32、cope 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 management process is made, the risk management process needs to be in compliance wi
33、th 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 corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk
34、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 foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does
35、 not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZB.1 Correspondence between this European Standard and Directive 93/42/EEC Clauses of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10,11 8.3 Only attainme
36、nt of sterility by aseptic processing is considered by this standard. This relevant Essential Requirement is only partly addressed in this European Standard. Design and packaging for maintenance of sterility during transportation and storage are not covered. Aspects of manufacture other than those r
37、elated to aseptic processing are not covered. 4,5,6,7,8,9,10,11 8.4 This relevant Essential Requirement is only partly addressed in this European Standard. Aspects of manufacture other than those related to aseptic processing are not covered. WARNING Other requirements and other EU Directives may be
38、 applicable to the product(s) falling within the scope of this Standard. EN ISO 13408-7:2015 (E) BS EN ISO 13408-7:20156Annex 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 Stan
39、dard 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 98/79/EC on in vitro diagnostic medical devices. Once this standard is cited in the Official
40、 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 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
41、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 98/79/EC. This means that risks have to be reduced as far
42、 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 Part A: 1, 2 and 5; Part B: 1.2, 2, 3
43、, 5, 6, and 7 of the Directive. NOTE 3 This Annex ZA 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 ZA.1, it means that it is not addressed by thi
44、s European Standard. 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 4,5,6,7,8,9,10,11 B.2.3 Only attainment of sterility by aseptic processing is considered by this standar
45、d. This relevant Essential Requirement is only partly addressed in this European Standard. Design and packaging for maintenance of sterility during transportation and storage are not covered. Aspects of manufacture other than those related to aseptic processing are not covered. 4,5,6,7,8,9,10,11 B.2
46、.4 This relevant Essential requirement is addressed in this International Standard only with regard to: - aseptic processing to attain sterility, not covering other special microbiological state - medical devices for which aseptic processing is appropriate WARNING Other requirements and other EU Dir
47、ectives may be applicable to the product(s) falling within the scope of this Standard. EN ISO 13408-7:2015 (E) BS EN ISO 13408-7:20157 ISO 2012 All rights reserved Contents PageForeword .Introduction 1 Scope 112 Normative references . 113 Terms and definitions . 114 Quality system elements .5 Asepti
48、c process definition 5.1 General .5.2 Risk management 6 Manufacturing environment .7 Equipment .8 Personnel .9 Manufacture of the product 10 Process simulation .10.1 General .10.2 Media selection and growth support10.3 Simulation procedures .10.4 Incubation and inspection of process simulation units
49、 .10.5 Initial performance qualification .10.6 Periodic performance requalification 10.7 Repeat of initial performance qualification 10.8 Documentation of process simulations 10.9 Disposition of filled product .11 Test for sterility 11.1 General .11.2 Investigation of positive units from tests for sterility .Annex A (informative) Risk assessment for aseptic processing Quality risk management method Annex B (informative) Selection of a sample for testing for microbial contamination Annex C (informative) Testing options f
