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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 11135/A1
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

Title (German)

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte - Änderung 1: Überarbeitung von Anhang E, Freigabe einer einzelnen Charge (ISO 11135:2014/Amd 1:2018)

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 11135/A1 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

Responsible national committee

Jenny Blum

Want to learn more?

EN ISO 11135/A1
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)