EN ISO 13408-2-2011 en Aseptic processing of health care products - Part 2 Filtration《医疗保健产品的无菌加工 第2部分 过滤》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 13408-2:2011Aseptic processing of healthcare productsPart 2: Filtration (ISO 13408-2:2003)BS EN ISO 13408-2:2011 BRITISH STANDARDNational forewordThis British Standard

2、is the UK implementation of EN ISO 13408-2:2011. It is identical to ISO 13408-2:2003. Together with the other parts of the BS EN ISO 13408 series, it supersedes BS EN 13824:2004.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices.A li

3、st 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 contract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 72614 9 ICS 11.080.01 Compliance with a Br

4、itish 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 issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13408-2

5、 June 2011 ICS 11.080.01 Supersedes EN 13824:2004English Version Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) Traitement aseptique des produits de sant - Partie 2: Filtration (ISO 13408-2:2003) Aseptische Herstellung von Produkten fr die Gesundheitsfrsorge - Tei

6、l 2: Filtration (ISO 13408-2:2003)This European Standard was approved by CEN on 10 June 2011. 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-dat

7、e 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 language made by translation

8、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, Denmark, Estonia, Finland, Fran

9、ce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR

10、 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 national Members. Ref. No. EN ISO 13408-2:2011: EBS EN ISO 13408-2:2011 EN ISO 13408-2:2011 (E) 3 Foreword The text of ISO 13408-2:2003 has been p

11、repared 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 13408-2:2011 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of which is held by BSI. T

12、his 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 shall be withdrawn at the latest by December 2011. Attention is drawn to the possibility that some

13、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. This document has been prepared under a mandate given to CEN by the European Commission and th

14、e 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 document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of t

15、he following countries are bound to implement this European Standard: 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, Romani

16、a, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 13408-2:2003 has been approved by CEN as a EN ISO 13408-2:2011 without any modification. BS EN ISO 13408-2:2011EN ISO 13408-2:2011 (E) 4 Annex ZA (informative) Relationship between this Europ

17、ean 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 European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirem

18、ents 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 implemented as a national standard in at least one Member State, compliance with the clauses of this standa

19、rd 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. Table ZA.1 Correspondence between this European Standard and Directive 90/385/EEC Clauses of t

20、his EN Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10,11,12 7 This relevant Essential Requirement is only partly addressed in this European Standard and only in conjunction with EN ISO 13408-1 WARNING Other requirements and other EU Directives may be app

21、licable to the product(s) falling within the scope of this Standard. BS EN ISO 13408-2:2011 EN ISO 13408-2:2011 (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 prepare

22、d 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 cited in the Official Journal of the European Union under tha

23、t 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 ZB.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Direc

24、tive and associated EFTA regulations. 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 4,5,6,7,8,9,10,11,12 8.3 This relevant Essential Requirement is only partly addressed

25、 in this European Standard and only in conjunction with EN ISO 13408-1 4,5,6,7,8,9,10,11,12 8.4 This relevant Essential Requirement is addressed in this European standard only in conjunction with EN ISO 13408-1 WARNING Other requirements and other EU Directives may be applicable to the product(s) fa

26、lling within the scope of this Standard. BS EN ISO 13408-2:2011EN ISO 13408-2:2011 (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

27、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 Journal of the European Union

28、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 ZC.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of t

29、hat Directive 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 4,5,6,7,8,9,10,11,12 B.2.3 This relevant Essential Requirement is only partly

30、addressed in this European Standard and only in conjunction with EN ISO 13408-1 4,5,6,7,8,9,10,11,12 B.2.4 This relevant Essential Requirement is addressed in this European standard only in conjunction with EN ISO 13408-1 WARNING Other requirements and other EU Directives may be applicable to the pr

31、oduct(s) falling within the scope of this Standard. BS EN ISO 13408-2:2011ISO 13408-2:2003(E) ISO 2003 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 General requirements. 3 5 Selection of filters and filter assemblie

32、s based on filter manufacturers data. 3 6 Fluid-specific selection criteria based on filter users data 3 7 Filtration process 4 7.1 Process parameters 4 7.2 Validation of fluid-specific microbial retention by filters 5 8 Filtration system design. 7 9 Routine process 8 10 Process documentation . 8 11

33、 Maintenance and change control 9 12 Operator training. 9 Annex A (informative) Basic information and quality certificates for filter cartridges. 10 Bibliography . 11 BS EN ISO 13408-2:2011ISO 13408-2:2003(E) iv ISO 2003 All rights reservedForeword ISO (the International Organization for Standardiza

34、tion) 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 for which a technical committee has been established has the right to be

35、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) on all matters of electrotechnical standardization. International Standard

36、s 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 are circulated to the member bodies for voting. Publication as an Interna

37、tional 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 held responsible for identifying any or all such patent rights. ISO 13408-2 w

38、as prepared by Technical Committee ISO/TC 198, Sterilization 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 The following parts are under preparation: Part 3: Free

39、ze-drying Part 4: Sterilization in place Part 5: Cleaning in place Part 6: Isolator/barrier technology BS EN ISO 13408-2:2011ISO 13408-2:2003(E) ISO 2003 All rights reserved vIntroduction During the process of preparing ISO 13408-1:1998, which addresses general requirements, several items, e.g. filt

40、ration, freeze-drying and steam-in-place, were found to be in need of supplementary information which was too large to be given in corresponding Annexes. This part of ISO 13408 includes requirements and guidance that are to be observed when aseptically manufacturing health care products by filtratio

41、n. ISO 13408-1:1998 will be revised soon after the publication of this part of ISO 13408, as clause 20 of ISO 13408-1:1998 is replaced by this part of ISO 13408. BS EN ISO 13408-2:2011BS EN ISO 13408-2:2011INTERNATIONAL STANDARD ISO 13408-2:2003(E) ISO 2003 All rights reserved 1Aseptic processing of

42、 health care products Part 2: Filtration 1 Scope This part of ISO 13408 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a s

43、terilizing filtration process, to be used for aseptic processing of health care products. This part of ISO 13408 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacter

44、ial whole-cell vaccines). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

45、ISO 13408-1:1998, Aseptic processing of health care products Part 1: General requirements ISO/TS 11139:2001, Sterilization of health care products Vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 13408-1, ISO/TS 11139 and the following appl

46、y. 3.1 bacterial challenge test test to evaluate the capability of a filter to retain organisms from a bacterial suspension under defined conditions 3.2 bioburden population of viable microorganisms in a fluid prior to sterilizing filtration NOTE For the purposes of this part of ISO 13408, the defin

47、ition of bioburden is narrower than that in ISO/TS 11139. 3.3 chemical compatibility ability of the process fluids not to adversely affect the properties of filter materials and/or filter assembly components and vice versa 3.4 fibre particle having an aspect (length-to-width) ratio of 10 or more ISO

48、 14644-1:1999, 2.2.7 BS EN ISO 13408-2:2011ISO 13408-2:2003(E) 2 ISO 2003 All rights reserved3.5 fibre-releasing filter filter which, even after any appropriate treatment such as washing or flushing, will release fibres into the filtrate 3.6 filter porous material through which a liquid or a gas is

49、passed to remove viable and non-viable particles 3.7 filter assembly filter cartridge(s) or filter material installed into a housing or holder NOTE This can be done by the filter user or by the filter manufacturer, e.g. in the form of pre-assembled filter units. 3.8 filter cartridge filter material assembled into a unit 3.9 filter equipment gauge, valve and other items attached to filter assembly 3.10 filtration process to remove viable and/or non-viable particles from liquids and/or gases by passage through a porous material