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DIN Standards Committee Quality Management, Statistics and Certification

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Standards [CURRENT]

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 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019

Title (German)

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 11135:2014 + Amd.1:2018); Deutsche Fassung EN ISO 11135:2014 + A1:2019

Document: references other documents

Document: referenced in other documents

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 2020-04
Original language German
Translation English
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