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Publications of CEN/TC 204

Order from DIN Media
DIN EN ISO 11737-1 2021-10 Standards Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021 More  Order from DIN Media
DIN EN ISO 11737-1 2026-04 Draft standard Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO/DIS 11737-1:2026); German and English version prEN ISO 11737-1:2026 More 
DIN EN ISO 11737-2 2020-07 Standards Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020 More  Order from DIN Media
DIN EN ISO 11737-3 2026-03 Draft standard Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (ISO 11737-3:2023); German and English version prEN ISO 11737-3:2026 More  Read draft and comment
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
DIN EN ISO 13408-1 2024-09 Standards Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023); German version EN ISO 13408-1:2024 More  Order from DIN Media
DIN EN ISO 13408-2 2018-06 Standards Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018); German version EN ISO 13408-2:2018 More  Order from DIN Media
DIN EN ISO 13408-2/A1 2025-11 Draft standard Aseptic processing of health care products - Part 2: Sterilizing filtration - Amendment 1 (ISO 13408-2:2018/DAM 1:2025); German and English version EN ISO 13408-2:2018/prA1:2025 More  Order from DIN Media
DIN EN ISO 13408-3 2011-09 Standards Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006); German version EN ISO 13408-3:2011 More  Order from DIN Media
DIN EN ISO 13408-4 2011-09 Standards Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005); German version EN ISO 13408-4:2011 More  Order from DIN Media

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