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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Smart Farming Standards and specifications are drivers for the digitalization of agriculture
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Draft standard

FprEN 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/FDIS 11137-1:2024)

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/FDIS 11137-1:2024)

Responsible national committee

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

Edition 2024-12

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

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

FprEN 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/FDIS 11137-1:2024)

Responsible national committee

Want to learn more?

FprEN 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/FDIS 11137-1:2024)