ISO/TC 198
| Registration number (WIID) | Project No. | Title | Status |
|---|---|---|---|
| 70799 | ISO 11607-1:2019 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems | 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 |
| 73159 | ISO 14160:2020 | Sterilization 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 devices | Standarts spēkā |
| 66566 | ISO/TS 19930:2017 | Guidance 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 10-6 | 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 |
| 73256 | ISO/TS 22456:2021 | Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products | 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 |
| 74113 | ISO 11138-7:2019 | Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results | Standarts spēkā |
| 66442 | ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements | Standarts spēkā |
| 40140 | ISO 11140-3:2007 | Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test | Standarts spēkā |
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