ISO/TC 198

Registration number (WIID)Project No.TitleStatus
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
70799ISO 11607-1:2019Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systemsStandarts spēkā
70800ISO 11607-2:2019Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processesStandarts 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
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
70822ISO 25424:2018Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devicesStandarts spēkā
70844ISO/CD 15883-1Washer-disinfectors — Part 1: General requirements, terms and definitions and testsStandarts spēkā
70849ISO/TS 21387:2020Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric releaseStandarts spēkā
70864ISO/CD 17665.2Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devicesStandarts spēkā
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