Registration number (WIID)Project No.TitleStatus
80410EN ISO 13408-1:2024/prA1Aseptic processing of health care products — Part 1: General requirements — Amendment 1Izstrādē
21959CEN/TC 204 N 470Sterilization of medical devices - Development, validation and routine control of sterilization processes - Low Temperature Steam and FormaldehydeIzstrādē
9310prEN ISO 11137-3Sterilization of medical devices - Microbiological methods - Part 3: Guidance on the evaluation and interpretation of bioburden dataIzstrādē
62287prEN ISO 17665-1 revSterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devicesIzstrādē
83788prEN ISO 13408-4 revAseptic processing of health care products — Part 4: Cleaning processes for surfaces used within a critical processing zoneIzstrādē
67200FprEN ISO 18362Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016)Izstrādē
77012EN ISO 13004:2023Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)Izstrādē
82923EN ISO 14937:2009/prA1Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices — Amendment 1Izstrādē
31155prEN ISO 11137-2Sterilization of health care products - Radiation - Part 2: Establishing the sterilization doseIzstrādē
72399prEN ISO 11135Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023)Izstrādē
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