DIN EN ISO 13408-6-2013 Aseptic processing of health care products - Part 6 Isolator systems (ISO 13408-6 2005 + Amd 1 2013) German version EN ISO 13408-6 2011 + A1 2013《医疗保健产品的无菌加.pdf
《DIN EN ISO 13408-6-2013 Aseptic processing of health care products - Part 6 Isolator systems (ISO 13408-6 2005 + Amd 1 2013) German version EN ISO 13408-6 2011 + A1 2013《医疗保健产品的无菌加.pdf》由会员分享,可在线阅读,更多相关《DIN EN ISO 13408-6-2013 Aseptic processing of health care products - Part 6 Isolator systems (ISO 13408-6 2005 + Amd 1 2013) German version EN ISO 13408-6 2011 + A1 2013《医疗保健产品的无菌加.pdf(28页珍藏版)》请在麦多课文档分享上搜索。
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
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