DIN EN ISO 13408-5-2011 Aseptic processing of health care products - Part 5 Sterilization in place (ISO 13408-5 2006) German version EN ISO 13408-5 2011《医疗保健产品的无菌加工 第5部分 在位消毒(ISO 1.pdf
《DIN EN ISO 13408-5-2011 Aseptic processing of health care products - Part 5 Sterilization in place (ISO 13408-5 2006) German version EN ISO 13408-5 2011《医疗保健产品的无菌加工 第5部分 在位消毒(ISO 1.pdf》由会员分享,可在线阅读,更多相关《DIN EN ISO 13408-5-2011 Aseptic processing of health care products - Part 5 Sterilization in place (ISO 13408-5 2006) German version EN ISO 13408-5 2011《医疗保健产品的无菌加工 第5部分 在位消毒(ISO 1.pdf(25页珍藏版)》请在麦多课文档分享上搜索。
1、September 2011 Translation by DIN-Sprachendienst.English price group 13No 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).
2、ICS 11.080.01!$tk#“1817200www.din.deDDIN EN ISO 13408-5Aseptic processing of health care products Part 5: Sterilization in place (ISO 13408-5:2006)English translation of DIN EN ISO 13408-5:2011-09Aseptische Herstellung von Produkten fr die Gesundheitsfrsorge Teil 5: Sterilisation vor Ort (ISO 13408-
3、5:2006)Englische bersetzung von DIN EN ISO 13408-5:2011-09Traitement aseptique des produits de sant Partie 5: Strilisation sur place (ISO 13408-5:2006)Traduction anglaise de DIN EN ISO 13408-5:2011-09Together with DIN EN ISO 13408-1:2011-09, DIN EN ISO 13408-2:2011-09, DIN EN ISO 13408-3:2011-09,DIN
4、 EN ISO 13408-4:2011-09 and DIN EN ISO 13408-6:2011-09 supersedes DIN EN 13824:2005-02Supersedes: see belowwww.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.2509.11 DIN EN ISO 13408-5:2011-09 National foreword This standard has been
5、prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” (Secretariat: ANSI, United States) in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation wa
6、s the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-01-12 AA Aseptische Herstellung. ISO 13408 consists of the following parts, under the general title Aseptic processing of health care products: Part 1: General requirements Part 2: Filtration Part 3: Lyophilization
7、 Part 4: Clean-in-place technologies Part 5: Sterilization in place Part 6: Isolator systems The following parts are in preparation: Part 7: Alternative processes for atypical medical devices and combination products Part 8: Cell based health care products Parts 1 to 6 of the DIN EN ISO 13408 series
8、 supersede DIN EN 13824, Sterilization of medical devices Aseptic processing of liquid medical devices Requirements. The DIN Standards corresponding to the International Standards referred to in this standard are as follows: ISO 9000 DIN EN ISO 9000 ISO 11138 (all parts) DIN EN ISO 11138 (all parts)
9、 ISO 11140 (all parts) DIN EN ISO 11140 (all parts) ISO 13408-1 DIN EN ISO 13408-1 ISO 13408-4 DIN EN ISO 13408-4 ISO 14161 DIN EN ISO 14161 ISO 14937 DIN EN ISO 14937 ISO 17665-1 DIN EN ISO 17665-1 ISO 22442 (all parts) DIN EN ISO 22442 (all parts) Amendments This standard differs from DIN EN 13824
10、:2005-02 as follows: a) the specifications relating to the sterilization in place have been updated and rendered more precise. Previous editions DIN EN 13824: 2005-02 2 DIN EN ISO 13408-5:2011-09 National Annex NA (informative) Bibliography DIN EN ISO 9000, Quality management systems Fundamentals an
11、d vocabulary DIN EN ISO 11138 (all parts), Sterilization of health care products Biological indicators DIN EN ISO 11140 (all parts), Sterilization of health care products Chemical indicators DIN EN ISO 13408-1, Aseptic processing of health care products Part 1: General requirements DIN EN ISO 13408-
12、4, Aseptic processing of health care products Part 4: Clean-in-place technologies DIN EN ISO 14161, Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results DIN EN ISO 14937, Sterilization of health care products General requirements f
13、or characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for 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 sterilizati
14、on process for medical devices DIN EN ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives 3 DIN EN ISO 13408-5:2011-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13408-5 June 2011 ICS 11.080.01 Supersedes EN 13824:200
15、4English Version Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) Traitement aseptique des produits de sant - Partie 5: Strilisation sur place (ISO 13408-5:2006) Aseptische Herstellung von Produkten fr die Gesundheitsfrsorge - Teil 5: Sterilisation vor O
16、rt (ISO 13408-5:2006) 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-date lists and
17、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 under the re
18、sponsibility 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, France, Germany,
19、 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 NORMUNG Man
20、agement 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 13408-5:2011: EContents Page1 Scope .52 Normative references .53 Terms and definitions .64 Quality system elements 74.1 Gene
21、ral 74.2 Management responsibility .74.3 Design control 74.4 Measuring instruments and measuring systems 75 Process and equipment characterization . 85.1 General concepts .85.2 Effectiveness of sterilization in place (SIP) .85.3 Equipment .86 Sterilizing agent characterization .106.1 Selection of st
22、erilizing agent(s) 6.2 Quality of sterilizing agent(s) . .106.3 Safety and the environment 107 SIP process .107.1 Process parameters .7.2 Cycle development .118 Validation .118.1 Validation protocol .118.2 Design qualification .118.3 Installation qualification 118.4 Operational qualification .128.5
23、Performance qualification .128.6 Review and approval of validation 148.7 Requalification 149 Routine monitoring and control 149.1 SIP process control 149.2 Procedures 149.3 SIP process records .159.4 Change control . 159.5 Maintenance of equipment 1510 Personnel training 15Annex A (informative) Stea
24、m sterilization in place 16Bibliography 20Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices 17Annex ZB (informative) Relationship between this European Standard and the Essential Requirem
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