ISO/TC 198

Registration number (WIID)Project No.TitleStatus
66451ISO 11737-1:2018Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on productsStandarts spēkā
66447ISO 11138-4:2017Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processesStandarts spēkā
77151ISO 13408-1:2023Aseptic processing of health care products — Part 1: General requirementsStandarts 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
74113ISO 11138-7:2019Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of resultsStandarts 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
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
70799ISO 11607-1:2019Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systemsStandarts spēkā
70821ISO 11135:2014/Amd 1:2018Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch releaseStandarts spēkā
46487ISO 15883-6:2011Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipmentStandarts spēkā
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