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Publications of ISO/TC 198/WG 2

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 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 13004 2023-10 Standards Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO 13004:2022); German version EN ISO 13004:2023 More  Order from DIN Media
ISO/TS 11137-4 2020-06 Pre-standard Sterilization of health care products - Radiation - Part 4: Guidance on process control More  Order from DIN Media
ISO 11137-1 2006-04 Standards Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More  Order from DIN Media
ISO 11137-1 AMD 1 2013-07 Standards Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1 More  Order from DIN Media
ISO 11137-1 AMD 2 2018-11 Standards 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 11.2 More  Order from DIN Media
ISO 11137-2 2013-06 Standards Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More  Order from DIN Media

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