CEN/TC 204
| Registration number (WIID) | Project No. | Title | Status |
|---|---|---|---|
| 78646 | prEN ISO 14937 | Sterilization 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 | Izstrādē |
| 9286 | prEN 553 | Sterilization of medical devices - Method for validation and routine control of sterilization by irradiation - Guidance | Izstrādē |
| 9291 | - | Method(s) of bioburden determination - Methods for validating bioburden techniques | Izstrādē |
| 76997 | CEN ISO/TS 11137-4:2023 | Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020) | Izstrādē |
| 77012 | EN ISO 13004:2023 | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022) | Izstrādē |
| 80411 | prEN ISO 11135 rev | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices | Izstrādē |
| 72619 | FprEN ISO 11137-1 | Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2024) | Izstrādē |
| 80417 | EN ISO 13408-2:2018/prA1 | Aseptic processing of health care products — Part 2: Sterilizing filtration — Amendment 1 | Izstrādē |
| 80418 | prEN ISO 11137-2 rev | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose | Izstrādē |
| 67200 | FprEN ISO 18362 | Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016) | Izstrādē |
Displaying 161-170 of 173 results.