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Publications of CEN/TC 204

CEN ISO/TS 11135-2/AC 2009-04 Pre-standard Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008/Cor 1:2009) More  Order from DIN Media
CEN ISO/TS 13004 2014-05 Pre-standard Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013) More  Order from DIN Media
CEN ISO/TS 17665-2 2009-01 Pre-standard Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) More  Order from DIN Media
DIN CEN ISO/TS 11137-4 2023-10 Technical Specification Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020); German version CEN ISO/TS 11137-4:2023 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
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 11137-1 2020-04 Standards Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019 More  Order from DIN Media
DIN EN ISO 11137-1 2023-05 Draft standard Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023 More  Order from DIN Media
DIN EN ISO 11137-2 2023-08 Standards Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023 More  Order from DIN Media
DIN EN ISO 11137-3 2017-11 Standards Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 More  Order from DIN Media

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