CEN/TC 204
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
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 |
76989 | EN ISO 17664-2:2023 | 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 |
58414 | EN ISO 13408-2:2018 | Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) | 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 |
65418 | EN ISO 11137-1:2015/A2:2019 | 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 |
40897 | 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 |
68124 | EN ISO 11737-1:2018/A1:2021 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021) | Standarts spēkā |
27791 | EN ISO 14937:2009 | 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 (ISO/FDIS 14937:2009) | Standarts spēkā |
62264 | EN ISO 25424:2019 | Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) | Standarts spēkā |
36593 | LVS 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 |
Displaying 131-140 of 173 results.