ISO/TC 198

Registration number (WIID)Project No.TitleStatus
66262ISO 11139:2018Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standardsStandarts 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
30061ISO 13408-7:2012Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination productsStandarts 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
66445ISO 11138-2:2017Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processesStandarts 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
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
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
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
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