ISO/TC 198

Registration number (WIID)Project No.TitleStatus
63841ISO 11137-3:2017Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine controlStandarts spēkā
73159ISO 14160:2020Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesStandarts spēkā
66451ISO 11737-1:2018Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on productsStandarts spēkā
77151ISO 13408-1:2023Aseptic processing of health care products — Part 1: General requirementsStandarts spēkā
66447ISO 11138-4:2017Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processesStandarts spēkā
76555ISO/TS 16775:2021Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2Standarts 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
56137ISO 11135:2014Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devicesStandarts spēkā
73158ISO/TS 22421:2021Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilitiesStandarts spēkā
66450ISO 18472:2018Sterilization of health care products — Biological and chemical indicators — Test equipmentStandarts spēkā
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