NA 063

DIN Standards Committee Medicine

Standards [Withdrawn]

DIN EN ISO 11137-1
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

Title (German)

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


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.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 063-04-10 AA - Sterilization and processing of medical devices 

Responsible european committee

CEN/TC 204 - Sterilization of medical devices 

Responsible international committee

ISO/TC 198/WG 2 - Radiation sterilization 

Edition 2015-11
Original language German
Translation English
Price from 129.90 €
Table of contents



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