DIN EN ISO 13408-7-2015 Aseptic processing of health care products - Part 7 Alternative processes for medical devices and combination products (ISO 13408-7 2012) German version EN .pdf
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1、November 2015 English price group 17No 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 11.080.01!%GR:“2364723www.din.d
2、eDIN EN ISO 13408-7A s e p t i c p r o c e s s i n g o f h e a l t h c a r e p r o d u c t s P a r t 7 : A l t e r n a t i v e p r o c e s s e s f o r m e d i c a l d e v i c e s a n d c o m b i n a t i o n p r o d u c t s ( I S O 1 3 4 0 8 - 7 : 2 0 1 2 ) ;E n g l i s h v e r s i o n E N I S O 1 3
3、4 0 8 - 7 : 2 0 1 5 ,English translation of DIN EN ISO 13408-7:2015-11A s e p t i s c h e H e r s t e l l u n g v o n P r o d u k t e n f r d i e G e s u n d h e i t s f r s o r g e T e i l 7 : A l t e r n a t i v e V e r f a h r e n f r M e d i z i n p r o d u k t e u n d K o m b i n a t i o n s p
4、r o d u k t e ( I S O 1 3 4 0 8 - 7 : 2 0 1 2 ) ;E n g l i s c h e F a s s u n g E N I S O 1 3 4 0 8 - 7 : 2 0 1 5 ,Englische bersetzung von DIN EN ISO 13408-7:2015-11T r a i t e m e n t a s e p t i q u e d e s p r o d u i t s d e s a n t P a r t i e 7 : P r o c d s a l t e r n a t i f s p o u r l e
5、 s d i s p o s i t i f s m d i c a u x e t l e s p r o d u i t s d e c o m b i n a i s o n ( I S O 1 3 4 0 8 - 7 : 2 0 1 2 ) ;V e r s i o n a n g l a i s e E N I S O 1 3 4 0 8 - 7 : 2 0 1 5 ,Traduction anglaise de DIN EN ISO 13408-7:2015-11www.beuth.deDocument comprises 30 pagesDTranslation by DIN-S
6、prachendienst.In case of doubt, the German-language original shall be considered authoritative.11.15 DIN EN ISO 13408-7:2015-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 13408-7:2015) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health
7、care products” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Comm
8、ittee NA 063-01-12 AA Aseptische Herstellung. In the German version of this document, the word Verfahrenssimulation is used synonymously with Prozesssimulation. EN ISO 13408 consists of the following parts, under the general title Aseptic processing of health care products: Part 1: General requireme
9、nts 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 DIN Standards corresponding to the International Standards referred to in this docu
10、ment are as follows: ISO 11137-2 DIN EN ISO 11137-2 ISO 11737-2 DIN EN ISO 11737-2 ISO 13408-1 DIN EN ISO 13408-1 ISO 13485 DIN EN ISO 13485 ISO 14971:2007 DIN EN ISO 14971:2013-04 ISO 14644 (all parts) DIN EN ISO 14644 (all parts) ISO 14698 (all parts) DIN EN ISO 14698 (all parts) DIN EN ISO 13408-
11、7:2015-11 3 National Annex NA (informative) Bibliography DIN EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose DIN EN ISO 11737-2, Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition
12、, validation and maintenance of a sterilization process DIN EN ISO 13408-1, Aseptic processing of health care products Part 1: General requirements DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14971, Medical devices Application of risk
13、management to medical devices DIN EN ISO 14644 (all parts), Cleanrooms and associated controlled environments DIN EN ISO 14698 (all parts), Cleanrooms and associated controlled environments Biocontamination control DIN EN ISO 13408-7:2015-11 4 This page is intentionally blank EUROPEAN STANDARD NORME
14、 EUROPENNE EUROPISCHE NORM EN ISO 13408-7 August 2015 ICS 11.080.01 English Version Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) Traitement aseptique des produits de sant - Partie 7: Procds alternatifs pour
15、 les dispositifs mdicaux et les produits de combinaison (ISO 13408-7:2012) Aseptische Herstellung von Produkten fr die Gesundheitsfrsorge - Teil 7: Alternative Verfahren fr Medizinprodukte und Kombinationsprodukte(ISO 13408-7:2012) This European Standard was approved by CEN on 30 July 2015. CEN memb
16、ers 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 bibliographical references concerning such national standards may be obtained on applicati
17、on 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 responsibility of a CEN member into its own language and notified to the CEN-CENELEC Managem
18、ent 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
19、Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 1
20、7, 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 13408-7:2015 EContents PageEuropean foreword 3Introduction 41 Scope 52 Normative references . 53 Terms and definitions . 54 Quality system elements . 65 As
21、eptic process definition 65.1 General . 65.2 Risk management 66 Manufacturing environment . 77 Equipment . 78 Personnel . 79 Manufacture of the product 710 Process simulation . 710.1 General . 710.2 Media selection and growth support 710.3 Simulation procedures . 710.4 Incubation and inspection of p
22、rocess simulation units . 1010.5 Initial performance qualification . 1010.6 Periodic performance requalification 1010.7 Repeat of initial performance qualification 1110.8 Documentation of process simulations 1110.9 Disposition of filled product . 1111 Test for sterility 1111.1 General . 1111.2 Inves
23、tigation of positive units from tests for sterility . 11Annex A (informative) Risk assessment for aseptic processing Quality risk management method 12Annex B (informative) Selection of a sample for testing for microbial contamination 19Annex C (informative) Testing options for process simulation .20
24、Bibliography .26Annex ZA Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices 23 Annex ZB Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 24
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