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Standard [WITHDRAWN]

DIN EN ISO 11137-1:2013-12

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd 1:2013); German version EN ISO 11137-1:2006 + A1:2013

German title
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 11137-1:2006 + Amd 1:2013); Deutsche Fassung EN ISO 11137-1:2006 + A1:2013
Publication date
2013-12
Original language
German
Pages
53

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Publication date
2013-12
Original language
German
Pages
53

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Overview

This new edition of ISO 11137-1 incorporates Amendment A1 into the existing standard. The amendment mainly includes the revision of normative references, terms and definitions. Furthermore, the English language version has been revised to achieve consistent terminology. This standard has been prepared by ISO/TC 198 "Sterilization of health care products" (secretariat: ANSI, USA), in collaboration with CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom). On the national level, Working Committee NA 063-01-07 AA "Sterilisation von Medizinprodukten" ("Sterilization of medical devices") at the Medicine Standards Committee (NAMed) is responsible.

Content
ICS
11.080.99
Replacement amendments

This document replaces DIN EN ISO 11137-1:2006-07 .

This document has been replaced by: DIN EN ISO 11137-1:2015-11 .

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