ISO/TC 194

Registration number (WIID)Project No.TitleStatus
74151ISO 10993-23:2021Biological evaluation of medical devices — Part 23: Tests for irritationStandarts spēkā
64750ISO 10993-18:2020Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management processStandarts spēkā
65918ISO/TR 10993-22:2017Biological evaluation of medical devices — Part 22: Guidance on nanomaterialsStandarts spēkā
68936ISO 10993-1:2018Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management processStandarts spēkā
72766ISO 10993-7:2008/Amd 1:2019Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infantsStandarts 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
88205ISO 10993-12:2021/Amd 1:2025Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1Standarts spēkā
88200ISO 10993-23:2021/Amd 1:2025Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis modelsStandarts spēkā
86862ISO 10993-4:2017/Amd 1:2025Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1Standarts spēkā
83916ISO/TS 11796:2023Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devicesStandarts spēkā
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