CEN/TC 204
| Registration number (WIID) | Project No. | Title | Status |
|---|---|---|---|
| 62262 | LVS EN ISO 11135:2014/A1:2020 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018) | Standarts spēkā |
| 60762 | LVS EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) | Standarts spēkā |
| 65357 | LVS EN ISO 14160:2021 | Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) | Standarts spēkā |
| 40897 | LVS EN ISO 13408-7:2015 | Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) | Standarts spēkā |
| 77012 | LVS EN ISO 13004:2023 | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022) | Standarts spēkā |
| 76163 | EN 556-1:2024 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices | Standarts spēkā |
| 72687 | LVS EN ISO 11137-2:2015/A1:2023 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022) | Standarts spēkā |
| 76989 | LVS EN ISO 17664-2:2024 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021) | Standarts spēkā |
| 76997 | LVS CEN ISO/TS 11137-4:2023 | Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020) | Standarts spēkā |
| 65418 | LVS EN ISO 11137-1:2015/A2:2020 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018) | Standarts spēkā |
Displaying 1-10 of 173 results.