CEN/TC 204
| Registration number (WIID) | Project No. | Title | Status |
|---|---|---|---|
| 72619 | FprEN ISO 11137-1 | Sterilization 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 |
| 77012 | EN ISO 13004:2023 | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022) | Izstrādē |
| 67200 | FprEN ISO 18362 | Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016) | Izstrādē |
| 9310 | prEN ISO 11137-3 | Sterilization of medical devices - Microbiological methods - Part 3: Guidance on the evaluation and interpretation of bioburden data | Izstrādē |
| 80410 | EN ISO 13408-1:2024/prA1 | Aseptic processing of health care products — Part 1: General requirements — Amendment 1 | Izstrādē |
| 9284 | prEN 551 | Sterilization of medical devices - Method for validation and routine control of ethylene oxide sterilization - Guidance | Izstrādē |
| 79283 | prEN ISO 11737-1 rev | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products | Izstrādē |
| 78154 | prCEN ISO/TS 17664-3 | Processing 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 classification | Izstrādē |
| 21959 | CEN/TC 204 N 470 | Sterilization of medical devices - Development, validation and routine control of sterilization processes - Low Temperature Steam and Formaldehyde | Izstrādē |
| 9291 | - | Method(s) of bioburden determination - Methods for validating bioburden techniques | Izstrādē |
Displaying 161-170 of 176 results.