ISO/TC 194

Registration number (WIID)Project No.TitleStatus
86862ISO 10993-4:2017/Amd 1:2025Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1Standarts spēkā
71514ISO/TS 21726:2019Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituentsStandarts spēkā
84824ISO 10993-7:2026Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residualsStandarts spēkā
61089ISO 10993-6:2016Biological evaluation of medical devices — Part 6: Tests for local effects after implantationStandarts spēkā
64750ISO 10993-18:2020Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management processStandarts spēkā
88201ISO 10993-17:2023/Amd 1:2025Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1Standarts spēkā
44050ISO 10993-13:2010Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devicesStandarts spēkā
35979ISO/TS 10993-20:2006Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devicesStandarts spēkā
83968ISO 14155:2026Clinical investigation of medical devices for human subjects — Good clinical practiceStandarts spēkā
65918ISO/TR 10993-22:2017Biological evaluation of medical devices — Part 22: Guidance on nanomaterialsStandarts spēkā
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