ISO/TC 198

Registration number (WIID)Project No.TitleStatus
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
70801ISO 11737-2:2019Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processStandarts spēkā
70800ISO 11607-2:2019Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processesStandarts spēkā
70799ISO 11607-1:2019Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systemsStandarts spēkā
69443ISO/TS 11137-4:2020Sterilization of health care products — Radiation — Part 4: Guidance on process controlStandarts spēkā
68297ISO 15883-5:2021Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacyStandarts 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
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 10-6Atcelts
66452ISO 13408-2:2018Aseptic processing of health care products — Part 2: Sterilizing filtrationStandarts spēkā
66451ISO 11737-1:2018Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on productsStandarts spēkā
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