ISO/TC 198

Registration number (WIID)Project No.TitleStatus
30061ISO 13408-7:2012Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination productsStandarts 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
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
42129ISO 11140-4:2007Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetrationStandarts spēkā
66451ISO 11737-1:2018Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on productsStandarts spēkā
68297ISO 15883-5:2021Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacyStandarts 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
69443ISO/TS 11137-4:2020Sterilization of health care products — Radiation — Part 4: Guidance on process controlStandarts 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
46487ISO 15883-6:2011Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipmentStandarts spēkā
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