ISO/TC 198

Registration number (WIID)Project No.TitleStatus
80823ISO/TS 5111:2022Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care productsStandarts spēkā
77151ISO 13408-1:2023Aseptic processing of health care products — Part 1: General requirementsStandarts 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
76555ISO/TS 16775:2021Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2Standarts spēkā
76249ISO 11737-3:2023Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testingStandarts spēkā
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
74113ISO 11138-7:2019Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of resultsStandarts spēkā
73392ISO 11138-5:2017/NP Amd 1Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes — Amendment 1: Annex C: Alternative method for determining the D-value of LTSF SCBIIzstrādē
73256ISO/TS 22456:2021Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based productsStandarts spēkā
73214ISO 22441:2022Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesStandarts spēkā
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