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NA 176

DIN Standards Committee Health Technologies

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Draft standard [New]

DIN EN ISO 11135
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025); German and English version prEN ISO 11135:2025

Title (German)

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 11135:2025); Deutsche und Englische Fassung prEN ISO 11135:2025

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 1 - Industrial ethylene oxide sterilization  

Edition 2025-08
Publication 2025-07-04
Public enquiry period until 2025-09-04
Original language German , English
Price from 238.30 €
Read draft and comment Order from DIN Media
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

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