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Publications of ISO/TC 198/WG 1

DIN EN ISO 11135 2024-04 Draft standard Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024 More  Order from DIN Media
DIN EN ISO 11135 2020-04 Standards Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 More  Order from DIN Media
ISO/TS 21387 2020-09 Pre-standard Sterilization of medical devices - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release More  Order from DIN Media
ISO 11135 2014-07 Standards Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More  Order from DIN Media
ISO 11135 AMD 1 2018-10 Standards Revision of Annex E, Single batch release More  Order from DIN Media

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