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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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Standards [CURRENT]

EN ISO 11137-1/A2
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 1 (ISO 11137-1:2006/Amd 2:2018)

Title (German)

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte - Änderung 2: Überarbeitung von 4.3.4 und 1 (ISO 11137-1:2006/Amd 2:2018)

Responsible national committee

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

Edition 2019-11

Original language English

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Table of contents

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Terminology

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

EN ISO 11137-1/A2 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 1 (ISO 11137-1:2006/Amd 2:2018)

Responsible national committee

Jenny Blum

Want to learn more?

EN ISO 11137-1/A2
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 1 (ISO 11137-1:2006/Amd 2:2018)