ISO/TC 198

Registration number (WIID)Project No.TitleStatus
81244ISO 25424:2018/CD Amd 1Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1Izstrādē
90093ISO/AWI 11137-2Sterilization of health care products — Radiation — Part 2: Establishing the sterilization doseIzstrādē
59405ISO/AWI 17210Test method to demonstrate the suitability of a medical device simulator during steam sterilization — Medical device simulator testingIzstrādē
89497ISO/AWI 25224Sterilization of health care products — Sampling and culturing for reusable, thermolabile flexible endoscopesIzstrādē
90413ISO/AWI 25442Sterilization of health care products — Test procedure for Measurement of temperature, pressure, and humidity in equipmentIzstrādē
86186ISO/AWI TS 17664-3Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 3: Guidance on the designation of a reusable medical device to a cleaning classification.Izstrādē
86250ISO/AWI TS 20327Packaging for terminally sterilized devices — Receiving, handling, transporting, distributing and storing of packaged sterile medical devices under the control of health care facilitiesIzstrādē
90415ISO/AWI TS 25443Sterilization of health care products — Moist heat — Guidance for verification of a process challenge device (PCD) to a specific load configurationIzstrādē
90483ISO/AWI TS 25462Sterilization of health care products — Ethylene oxide — Guidance on the validation and routine processing of sterilization processes using alternative approach to parametric releaseIzstrādē
88921ISO/CD 11138-6.2Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processesIzstrādē
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