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
39781ISO 13408-4:2005Aseptic processing of health care products — Part 4: Clean-in-place technologiesStandarts 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
40140ISO 11140-3:2007Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration testStandarts 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 10-6Standarts spēkā
73214ISO 22441:2022Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesStandarts spēkā
62337ISO 11138-8:2021Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicatorStandarts spēkā
76751ISO 11737-1:2018/Amd 1:2021Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1Standarts spēkā
30061ISO 13408-7:2012Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination productsStandarts spēkā
Displaying 181-190 of 209 results.