CEN/TC 204
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
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 |
36593 | EN ISO 11135:2014 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) | Standarts spēkā |
62251 | EN ISO 11737-2:2020 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) | 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 |
77012 | LVS EN ISO 13004:2023 | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022) | Standarts spēkā |
60761 | EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) | 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 |
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 |
76162 | EN 556-2:2024 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices | Standarts spēkā |
72112 | EN ISO 25424:2019/A1:2022 | Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022) | Standarts spēkā |
Displaying 21-30 of 173 results.