ISO/TC 198

Registration number (WIID)Project No.TitleStatus
74152ISO 17664-2:2021Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devicesStandarts spēkā
76249ISO 11737-3:2023Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testingStandarts spēkā
76555ISO/TS 16775:2021Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2Standarts spēkā
76751ISO 11737-1:2018/Amd 1:2021Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1Standarts spēkā
77151ISO 13408-1:2023Aseptic processing of health care products — Part 1: General requirementsStandarts spēkā
80823ISO/TS 5111:2022Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care productsStandarts spēkā
81244ISO 25424:2018/CD Amd 1Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1Izstrādē
81821ISO 25424:2018/Amd 1:2022Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1Standarts spēkā
83351ISO 11139:2018/Amd 1:2024Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitionsStandarts spēkā
84377ISO 15883-2:2024Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devicesStandarts spēkā
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