• Hydrogen Technologies Standards form the basic framework for market ramp-up

    More information
  • Climate change Standards and specifications support climate targets

    More information
  • Smart Farming Standards and specifications are drivers for the digitalization of agriculture

    More information
Draft standard

DIN EN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023

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/DIS 11137-1:2023); Deutsche und Englische Fassung prEN ISO 11137-1:2023

Responsible national committee

NA 176-03-09 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 2023-05
Original language German , English
Price from 146.40 €
Table of contents

Contact

Dipl.-Phys.

Jenny Blum

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2034
Fax: +49 30 2601-42034

Send message to contact