ISO/TC 198
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
62442 | ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose | Standarts spēkā |
70844 | ISO/CD 15883-1 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests | Standarts spēkā |
66445 | ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes | Standarts spēkā |
66442 | ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements | Standarts spēkā |
66448 | ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes | Standarts spēkā |
70800 | ISO 11607-2:2019 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes | Standarts spēkā |
30061 | ISO 13408-7:2012 | Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products | Standarts spēkā |
56137 | ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices | Standarts spēkā |
62244 | ISO 18362:2016 | Manufacture of cell-based health care products — Control of microbial risks during processing | Standarts spēkā |
76555 | ISO/TS 16775:2021 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 | Standarts spēkā |
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