DIN - German Institute for Standardization

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Hydrogen Technologies Standards form the basic framework for market ramp-up
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Climate change Standards and specifications support climate targets
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Draft standard [New]

FprEN 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/FDIS 11135:2026)

Title (German)

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO/FDIS 11135:2026)

Responsible national committee

NA 176-03-09 AA - Sterilization and processing of medical devices

Edition 2026-09

Original language English

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

Climate change Standards and specifications support climate targets

FprEN 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/FDIS 11135:2026)

Responsible national committee

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FprEN 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/FDIS 11135:2026)