ISO/TC 198

Registration number (WIID)Project No.TitleStatus
84377ISO 15883-2:2024Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devicesStandarts spēkā
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
74113ISO 11138-7:2019Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of resultsStandarts 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
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
77151ISO 13408-1:2023Aseptic processing of health care products — Part 1: General requirementsStandarts spēkā
70799ISO 11607-1:2019Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systemsStandarts spēkā
63696ISO 15883-4:2018Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopesStandarts spēkā
68297ISO 15883-5:2021Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacyStandarts spēkā
69443ISO/TS 11137-4:2020Sterilization of health care products — Radiation — Part 4: Guidance on process controlStandarts spēkā
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