ISO 11135:2014/Amd 1:2018

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

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

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Referenced standards

ISO 10993-7ISO 11138-7ISO 11737-1ISO 11737-2
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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

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

Edition2018
Standard Part No/Amd 1
Published Date2018
Published ByInternational Standardization Organisation
Page Count4