ISO/TC 198

Registration number (WIID)Project No.TitleStatus
66625ISO 11140-6:2022Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizersStandarts spēkā
66448ISO 11138-5:2017Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processesStandarts 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
70844ISO/CD 15883-1Washer-disinfectors — Part 1: General requirements, terms and definitions and testsStandarts spēkā
55080ISO 11140-1:2014Sterilization of health care products — Chemical indicators — Part 1: General requirementsStandarts spēkā
39778ISO 20857:2010Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devicesStandarts 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
76555ISO/TS 16775:2021Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2Standarts 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
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
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