BS EN ISO 13408-1-2015 Aseptic processing of health care products General requirements《保健品的无菌加工 通用要求》.pdf

1、BSI Standards PublicationBS EN ISO 13408-1:2015Aseptic processing of healthcare productsPart 1: General requirementsBS EN ISO 13408-1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 13408-1:2015. It is identical to ISO 13408-1:2008, incorporating amendm

2、ent 1:2013. It supersedes BS EN ISO 13408-1:2011+A1:2013 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags.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 text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is ind

3、icated by .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 committee can be obtained on request to its secretary.This publication does not purport to include all the

4、necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 90760 9ICS 11.080.01Compliance with a British Standard cannot confer immunity from legal obligations.This British Stand

5、ard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13408-1 June 2015 ICS 11.080.01 Supersedes EN ISO 13408-1:2011English Version Aseptic p

6、rocessing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) Traitement aseptique des produits de sant - Partie 1: Exigences gnrales (ISO 13408-1:2008, y compris Amd 1:2013) Aseptische Herstellung von Produkten fr die Gesundheitsfrsorge - Teil 1: Allgemei

7、ne Anforderungen (ISO 13408-1:2008, einschlielich Amd 1:2013) This European Standard was approved by CEN on 20 May 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 withou

8、t 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 versions (English, French, German). A version in any other la

9、nguage 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, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denm

10、ark, 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, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE

11、 FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES 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 13408-1:2015 EBS EN ISO 13

12、408-1:2015EN ISO 13408-1:2015 (E) 2 Foreword The text of ISO 13408-1:2008, including Amd 1:2013 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 13408-1:2015 by Te

13、chnical Committee 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 2015, and conflicting national sta

14、ndards shall be withdrawn at the latest by December 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 document supersedes EN

15、ISO 13408-1:2011. 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 and ZC, which are integral part

16、s of this document. The following referenced documents are indispensable for the application of this document. For undated references, the edition of the referenced document (including any amendments) listed below applies. For dated references, only the edition cited applies. However, for any use of

17、 this standard within the meaning of Annex ZA, ZB or ZC, the user should always check that any referenced document has not been superseded 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 te

18、xt, this should 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 The way in which these referenced documents are cited in normative requirements determines the extent (in whole o

19、r 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 standard EN ISO ISO 9001 EN ISO 9001:2008 ISO 9001:2008 ISO 11135 EN ISO 11135:2014 ISO 11135:2014 ISO 11137-1

20、 EN ISO 11137-1:2006 + A1:2013 ISO 11137-1:2006 + A1:2013 ISO 11137-2 EN ISO 11137-2:2013 ISO 11137-2:2013 ISO 13408-2 EN ISO 13408-2:2011 ISO 13408-2:2011 ISO 13408-3 EN ISO 13408-3:2011 ISO 13408-3:2011 ISO 13408-4 EN ISO 13408-4:2011 ISO 13408-4:2011 ISO 13408-5 EN ISO 13408-5:2011 ISO 13408-5:20

21、11 ISO 13408-6 EN ISO 13408-6:2011 + A1:2013 ISO 13408-6:2011 + A1:2013 BS EN ISO 13408-1:2015EN ISO 13408-1:2015 (E)iiBS EN ISO 13408-1:2015EN ISO 13408-1:2015 (E) 3 Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 13485 EN ISO 13485:2012 ISO 13485

22、:2003 ISO 14160 EN ISO 14160:2011 ISO 14160:2011 ISO 14644-1 EN ISO 14644-1:1999 ISO 14644-1:1999 ISO 14644-2 EN ISO 14644-2:2000 ISO 14644-2:2000 ISO 14644-3 EN ISO 14644-3:2005 ISO 14644-3:2005 ISO 14644-4 EN ISO 14644-4:2001 ISO 14644-4:2001 ISO 14644-5 EN ISO 14644-5:2004 ISO 14644-5:2004 ISO 14

23、644-7 EN ISO 14644-7:2004 ISO 14644-7:2004 ISO 14698-1 EN ISO 14698-1:2003 ISO 14698-1:2003 ISO 14698-2 EN ISO 14698-2:2003 + A1:2006 ISO 14698-2:2003 + A1:2006 ISO 14937 EN ISO 14937:2009 ISO 14937:2009 ISO 14971 EN ISO 14971:2012 ISO 14971:2007 ISO 17665-1 EN ISO 17665-1:2006 ISO 17665-1:2006 ISO

24、20857 EN ISO 20857:2013 ISO 20857:2013 Regarding the reference to ICH Q9: Guidance for Industry Quality Risk Management, this should be considered to be the edition published in 2006. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries a

25、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

26、ortugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 13408-1:2008, including Amd 1:2013 has been approved by CEN as EN ISO 13408-1:2015 without any modification. BS EN ISO 13408-1:2015EN ISO 13408-1:2015 (E)iiiBS EN ISO 1

27、3408-1:2015EN ISO 13408-1:2015 (E) 4 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/CENELEC by the European Commis

28、sion 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 been implemen

29、ted as a national standard in at least one Member State, compliance with the normative 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 EFT

30、A 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 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 pos

31、sible 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 1, 4, 5, 8, 9 and 10 of the Directive. NOTE 3 This Annex ZA is based on normative

32、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 this European Standard. Table ZA.1 Correspondence between this European Standa

33、rd and Directive 90/385/EEC Clauses of this EN Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10,11 7 Only attainment of sterility by aseptic processing is considered by this standard. This relevant Essential Requirement is only partly addressed in this Eur

34、opean Standard. Design and packaging for maintenance of sterility during transportation and storage are not covered. Aspects of manufacture other than those related to sterilization are not covered. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within

35、 the scope of this Standard. BS EN ISO 13408-1:2015EN ISO 13408-1:2015 (E)ivBS EN ISO 13408-1:2015EN ISO 13408-1:2015 (E) 5 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 p

36、repared under a mandate given to CEN/CENELC 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 cited in the Official Journal of the European Un

37、ion 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 scope of this standard, a presumption of conformity with the corresponding Essential Req

38、uirements 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 93/42/EEC, as amended by 2007/47/EC. This means that risks have to be reduced as far

39、 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 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the

40、 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 this European Standard.

41、 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 attainment of sterility by aseptic processing is considered by this standard. This relevant Ess

42、ential 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 sterilization are not covered. 4,5,6,7,8,9,10,11 8.4 This relevant Essential

43、Requirement is only partly addressed in this European Standard. Aspects of manufacture other than those related to sterilization 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 13408-1:2015EN

44、 ISO 13408-1:2015 (E)vBS EN ISO 13408-1:2015EN ISO 13408-1:2015 (E) 6 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 given to CE

45、N/CENELEC 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 that

46、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 corresponding Essential Requirements of th

47、at 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 as possible, to a minimum, to the lowest

48、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, 5, 6, and 7 of the Directive. NOTE 3 Thi

49、s 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 this 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 co