ISO/TC 194

Registration number (WIID)Project No.TitleStatus
64582ISO 10993-16:2017Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesStandarts spēkā
64580ISO 10993-9:2019Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsStandarts spēkā
75323ISO 10993-17:2023Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituentsStandarts spēkā
68426ISO 10993-11:2017Biological evaluation of medical devices — Part 11: Tests for systemic toxicityStandarts spēkā
65052ISO/TR 10993-33:2015Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3Standarts 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
71862ISO/TR 10993-55:2023Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicityStandarts spēkā
88205ISO 10993-12:2021/Amd 1:2025Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — 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
86862ISO 10993-4:2017/Amd 1:2025Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1Standarts spēkā
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