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
64580ISO 10993-9:2019Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsStandarts spēkā
65918ISO/TR 10993-22:2017Biological evaluation of medical devices — Part 22: Guidance on nanomaterialsStandarts spēkā
73582ISO/TS 37137-1:2021Biological evaluation of absorbable medical devices — Part 1: General requirementsStandarts spēkā
55064ISO 10993-7:2008/Cor 1:2009Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1Standarts spēkā
36406ISO 10993-5:2009Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicityStandarts spēkā
65052ISO/TR 10993-33:2015Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3Standarts 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
88205ISO 10993-12:2021/Amd 1:2025Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1Standarts spēkā
64887ISO/TR 37137:2014Cardiovascular biological evaluation of medical devices — Guidance for absorbable implantsStandarts spēkā
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