CEN/TC 204

Registration number (WIID)Project No.TitleStatus
72112EN ISO 25424:2019/A1:2022Sterilization 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/DAM 1:2021)Standarts spēkā
76162EN 556-2:2024Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devicesStandarts spēkā
68466EN ISO 13408-1:2024Aseptic processing of health care products - Part 1: General requirements (ISO/DIS 13408-1:2021)Standarts spēkā
72618EN ISO 17664-1:2021Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)Standarts spēkā
60761EN ISO 11137-1:2015Sterilization 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
35152EN ISO 13408-5:2011Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)Standarts spēkā
40897LVS EN ISO 13408-7:2015Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)Standarts spēkā
76997LVS CEN ISO/TS 11137-4:2023Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)Standarts spēkā
35150LVS EN ISO 13408-4:2011Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)Standarts spēkā
76163LVS EN 556-1:2024Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devicesStandarts spēkā
Displaying 41-50 of 176 results.