ISO/TC 194

Registration number (WIID)Project No.TitleStatus
84512ISO 10993-1:2025Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management processStandarts spēkā
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
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
75279ISO 10993-10:2021Biological evaluation of medical devices — Part 10: Tests for skin sensitizationStandarts spēkā
68937ISO 10993-15:2019Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloysStandarts spēkā
64887ISO/TR 37137:2014Cardiovascular biological evaluation of medical devices — Guidance for absorbable implantsStandarts spēkā
88205ISO 10993-12:2021/Amd 1:2025Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1Standarts spēkā
65052ISO/TR 10993-33:2015Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3Standarts spēkā
Displaying 141-150 of 156 results.