ISO/TC 194

Registration number (WIID)Project No.TitleStatus
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
88201ISO 10993-17:2023/Amd 1:2025Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1Standarts spēkā
75769ISO 10993-12:2021Biological evaluation of medical devices — Part 12: Sample preparation and reference materialsStandarts spēkā
75279ISO 10993-10:2021Biological evaluation of medical devices — Part 10: Tests for skin sensitizationStandarts spēkā
22693ISO 10993-14:2001Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramicsStandarts spēkā
36406ISO 10993-5:2009Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicityStandarts spēkā
75323ISO 10993-17:2023Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituentsStandarts 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
65918ISO/TR 10993-22:2017Biological evaluation of medical devices — Part 22: Guidance on nanomaterialsStandarts spēkā
64580ISO 10993-9:2019Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsStandarts spēkā
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