ISO/TC 198

Registration number (WIID)Project No.TitleStatus
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
71418ISO/WD 11138-6Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processesStandarts spēkā
66566ISO/TS 19930:2017Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6Standarts spēkā
73159ISO 14160:2020Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesStandarts spēkā
86252ISO 15883-6:2026Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipmentStandarts spēkā
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
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
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
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