1、July 2013 Translation by DIN-Sprachendienst.English price group 14No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 1
2、1.080.01!%*p“2040777www.din.deDDIN EN ISO 13408-6Aseptic processing of health care products Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013);English version EN ISO 13408-6:2011 + A1:2013,English translation of DIN EN ISO 13408-6:2013-07Aseptische Herstellung von Produkten fr die Gesundheitsf
3、rsorge Teil 6: Isolatorensysteme (ISO 13408-6:2005 + Amd 1:2013);Englische Fassung EN ISO 13408-6:2011 + A1:2013,Englische bersetzung von DIN EN ISO 13408-6:2013-07Traitement aseptique des produits de sant Partie 6: Systmes isolateurs (ISO 13408-6:2005 + Amd 1:2013);Version anglaise EN ISO 13408-6:2
4、011 + A1:2013,Traduction anglaise de DIN EN ISO 13408-6:2013-07SupersedesDIN EN ISO 13408-6:2011-09www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.2807.13 DIN EN ISO 13408-6:2013-07 2 A comma is used as the decimal marker. National
5、 foreword This document (EN ISO 13408-6:2011 + A1:2013) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” (Secretariat: BSI, United Kingdom). The
6、 responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-01-12 AA Aseptische Herstellung. EN ISO 13408 consists of the following parts, under the general title Aseptic processing of health care products: Part 1: Gene
7、ral requirements Part 2: Filtration Part 3: Lyophilization Part 4: Clean-in-place technologies Part 5: Sterilization in place Part 6: Isolator systems Part 7: Alternative processes for medical devices and combination products The start and finish of text introduced or altered by amendment is indicat
8、ed in the text by tags !“. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 13408-1 DIN EN ISO 13408-1 ISO 13408-4 DIN EN ISO 13408-4 ISO 13408-5 DIN EN ISO 13408-5 ISO 14644-1 DIN EN ISO 14644-1 ISO 14644-7 DIN EN ISO 14644-7 ISO 14971
9、DIN EN ISO 14971 ISO 17665-1 DIN EN ISO 17665-1 ISO/TS 17665-2 DIN ISO/TS 17665-2 Amendments This standard differs from DIN EN ISO 13408-6:2009-11 as follows: a) normative references have been updated; b) the Bibliography has been updated. Previous editions DIN EN 13824: 2005-02 DIN EN ISO 13408-6:
10、2011-09 DIN EN ISO 13408-6:2013-07 3 National Annex NA (informative) Bibliography DIN EN ISO 13408-1, Aseptic processing of health care products Part 1: General requirements DIN EN ISO 13408-4, Aseptic processing of health care products Part 4: Clean-in-place technologies DIN EN ISO 13408-5, Aseptic
11、 processing of health care products Part 5: Sterilization in place DIN EN ISO 14644-1, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness DIN EN ISO 14644-7, Cleanrooms and associated controlled environments Part 7: Separative devices (clean air hoods, gloveb
12、oxes, isolators and mini-environments) DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medi
13、cal devices DIN ISO/TS 17665-2, Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1 DIN EN ISO 13408-6:2013-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13408-6 June 2011 + A1 March 2013 ICS 11.080.01 S
14、upersedes EN 13824:2004English Version Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) Traitement aseptique des produits de sant - Partie 6: Systmes isolateurs (ISO 13408-6:2005/Amd 1:2013) Aseptische Herstellung von Produkten fr die Gesundheitsf
15、rsorge - Teil 6: Isolatorensysteme (ISO 13408-6:2005 + Amd 1:2013) EN ISO 13408-6:2011 was approved by CEN on 2011-06-10 and Amendment A1:2013 on 2013-03-07. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the
16、 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 member. This European Standard exists in three official versions (English, Frenc
17、h, 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. CEN members are the national standards bodies of Austria, Belgium, Bulgaria,
18、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, Switzerland, Turkey a
19、nd United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 1
20、3408-6:2011 + A1:2013 EEN ISO 13408-6:2011 + A1:2013 (E) Contents Page Foreword to EN ISO 13408-6:2011 3 Foreword to EN ISO 13408-6:2011/A1:2013 .4 Introduction .5 1 Scope 6 2 Normative references 6 3 Terms and definitions .6 4 Quality system elements .7 4.1 General 7 4.2 Management responsibility 7
21、 4.3 Design control 8 4.4 Measuring instruments and measuring systems .8 5 Design of isolator systems .8 5.1 General 8 5.2 Types of isolators 8 5.3 Materials of construction 8 5.4 Air-handling system 9 5.5 Operator interface 10 5.6 Ancillary equipment 10 6 Facility requirements .11 6.1 Surrounding r
22、oom classification .11 6.2 Process utilities .11 7 User requirements .11 7.1 Product/process application 11 7.2 Ergonomics 11 7.3 Cleaning 12 7.4 Bio-decontamination .12 8 Validation 15 8.1 General 15 8.2 Design qualification .15 8.3 Installation qualification 15 8.4 Operational qualification .16 8.
23、5 Performance qualification .17 8.6 Review and approval of validation .18 8.7 Requalification .19 9 Routine monitoring and control .19 9.1 Procedures .19 9.2 System integrity .19 9.3 Bio-decontamination process monitoring 19 9.4 Environmental monitoring 19 9.5 Change control .20 9.6 Maintenance and
24、calibration 20 10 Personnel training .20 Bibliography 21 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices 22 Annex ZB (informative) Relationship between this European Standard and the Es
25、sential Requirements of EU Directive 93/42/EEC on Medical Devices .23 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices 24 2 DIN EN ISO 13408-6:2013-07 EN ISO 13408-6:2011 + A1:2013 (E) Fo
26、reword to EN ISO 13408-6:2011 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 Committee CEN/TC 204 “Sterili
27、zation 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 shall be withdrawn at the late
28、st 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. This document has been pr
29、epared 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 document. According to the CEN/CE
30、NELEC 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, Ireland, Italy, Latvia, Lithua
31、nia, 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 EN ISO 13408-6:2011 without any modification. 3 DIN EN ISO 13408-6:2013-07 EN ISO
32、 13408-6:2011 + A1:2013 (E) Foreword to EN ISO 13408-6:2011/A1:2013 This document (EN ISO 13408-6:2011/A1:2013) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” the secr
33、etariat 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 September 2013, and conflicting national standards shall be withdrawn at the latest by September 2013. Attention is
34、 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 has been prepared under a mandate given to CEN by the European Commission and the Eu
35、ropean 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 parts of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the f
36、ollowing 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherland
37、s, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The 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. 4 DIN EN ISO 13408-6:2013-07 EN ISO 13408-
38、6:2011 + A1:2013 (E) 5Introduction 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 asept
39、ic preparation and filling of solutions, suspensions, emulsions, and solids, as well as to the aseptic handling, transfer and filling of those products which cannot be terminally sterilized. Aseptic processing is an exacting and demanding discipline. It is essential that manufacturers make use of qu
40、alified/validated systems, adequately trained personnel, controlled environments and well-documented systematic processes to assure a sterile finished product. DIN EN ISO 13408-6:2013-07 EN ISO 13408-6:2011 + A1:2013 (E) 6 1 Scope This part of ISO 13408 specifies the requirements for isolator system
41、s used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this ma
42、y include applications for hazardous materials. This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions. 2 Normative references T
43、he 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. !ISO 13408-1:2008“, Aseptic processing of health c
44、are products Part 1: General requirements ISO 13408-4 !Deleted text“, Aseptic processing of health care products Part 4: Clean-in-place technologies ISO 13408-5 !Deleted text“, Aseptic processing of health care products Part 5: Sterilization in place ISO 14644-7:2004, Cleanrooms and associated contr
45、olled environments Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) ISO/IEC 90003, Software engineering Guidelines for the application of ISO 9001:2000 to computer software 3 Terms and definitions For the purposes of this document, the terms and definitions g
46、iven in !ISO 13408-1:2008“ and the following apply. !Deleted text“ !Deleted text“ !Deleted text“ !3.1“ isolator system isolator with transfer system(s) and ancillary equipment used for aseptic processing !3.2“ leak test physical test to identify a quantifiable leakage rate under repeatable test cond
47、itions !3.3“ material safety data sheet document specifying the properties of a material, its potential hazardous effects for humans and the environment, and the precautions necessary to handle and dispose of the material safely DIN EN ISO 13408-6:2013-07 EN ISO 13408-6:2011 + A1:2013 (E) 7!3.4“ ris
48、k assessment overall process comprising a risk analysis and a risk evaluation !ISO 14971:2007, definition 2.18“ !Deleted text“ !Deleted text“ !3.5“ transfer device mechanism to effect movement of material into or out of separative devices while minimizing ingress or egress of unwanted matter ISO 14644-7:2004, 3.18 EXAMPLES Transfer isolator, transfer container, and transfer system. !3.6“ transfer port interface between the interiors of an isolator and a transfer device that can be attached to an
