Standard [WITHDRAWN]
DIN EN ISO 11137-1:2015-11
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, including Amd 1:2013); German version EN ISO 11137-1:2015
- 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, einschließlich Amd 1:2013); Deutsche Fassung EN ISO 11137-1:2015
- Publication date
- 2015-11
- Original language
- German
- Pages
- 54
- Publication date
- 2015-11
- Original language
- German
- Pages
- 54
- DOI
- https://dx.doi.org/10.31030/2344179
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By decision of the CEN Technical Bureau (Resolution CEN/BT C52/2015), Annexes ZA, ZB and ZC and the European Preface have been updated and published in June 2015 as a new edition EN ISO 11137-1:2015. With this new edition of DIN EN ISO 11137-1, the foreword newly published by CEN, including Annexes Z, has been incorporated into the existing standard. The standard contains ISO 11137-1:2006 unchanged including amendment 1:2013. The 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, Great Britain). On the national level, DIN Working Committee NA 063-01-07 AA "Sterilisation von Medizinprodukten" ("Sterilization of medical devices") at NAMed is responsible.
This document replaces DIN EN ISO 11137-1:2013-12 .
This document has been replaced by: DIN EN ISO 11137-1:2020-04 .