ISO/TC 198
| Registration number (WIID) | Project No. | Title | Status |
|---|---|---|---|
| 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 |
| 83351 | ISO 11139:2018/Amd 1:2024 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions | Standarts spēkā |
| 70849 | ISO/TS 21387:2020 | Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release | Standarts spēkā |
| 70821 | ISO 11135:2014/Amd 1:2018 | Sterilization 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 release | Standarts spēkā |
| 69443 | ISO/TS 11137-4:2020 | Sterilization of health care products — Radiation — Part 4: Guidance on process control | Standarts spēkā |
| 71418 | ISO/WD 11138-6 | Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processes | Standarts spēkā |
| 68297 | ISO 15883-5:2021 | Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy | Standarts spēkā |
| 42129 | ISO 11140-4:2007 | Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration | Standarts spēkā |
| 80823 | ISO/TS 5111:2022 | Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products | 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 |
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