Registration number (WIID)Project No.TitleStatus
72619FprEN ISO 11137-1Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)Izstrādē
77012EN ISO 13004:2023Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)Izstrādē
67200FprEN ISO 18362Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016)Izstrādē
9310prEN ISO 11137-3Sterilization of medical devices - Microbiological methods - Part 3: Guidance on the evaluation and interpretation of bioburden dataIzstrādē
80410EN ISO 13408-1:2024/prA1Aseptic processing of health care products — Part 1: General requirements — Amendment 1Izstrādē
9284prEN 551Sterilization of medical devices - Method for validation and routine control of ethylene oxide sterilization - GuidanceIzstrādē
79283prEN ISO 11737-1 revSterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on productsIzstrādē
78154prCEN ISO/TS 17664-3Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 3: Guidance on the designation of a reusable medical device to a quantitative cleaning classificationIzstrādē
21959CEN/TC 204 N 470Sterilization of medical devices - Development, validation and routine control of sterilization processes - Low Temperature Steam and FormaldehydeIzstrādē
9291-Method(s) of bioburden determination - Methods for validating bioburden techniquesIzstrādē
Displaying 161-170 of 176 results.