Registration number (WIID)Project No.TitleStatus
76162EN 556-2:2024Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devicesStandarts spēkā
76989EN ISO 17664-2:2023Processing 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
58414EN ISO 13408-2:2018Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)Standarts spēkā
76163EN 556-1:2024Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devicesStandarts spēkā
65418EN ISO 11137-1:2015/A2:2019Sterilization 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
40897EN 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
68124EN ISO 11737-1:2018/A1:2021Sterilization 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
27791EN ISO 14937:2009Sterilization 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
62264EN ISO 25424:2019Sterilization 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
36593LVS EN ISO 11135:2014Sterilization 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
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