ISO/TC 194

Registration number (WIID)Project No.TitleStatus
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
64750ISO 10993-18:2020Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management processStandarts spēkā
65052ISO/TR 10993-33:2015Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3Standarts spēkā
65918ISO/TR 10993-22:2017Biological evaluation of medical devices — Part 22: Guidance on nanomaterialsStandarts spēkā
64582ISO 10993-16:2017Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesStandarts spēkā
75279ISO 10993-10:2021Biological evaluation of medical devices — Part 10: Tests for skin sensitizationStandarts spēkā
64580ISO 10993-9:2019Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsStandarts spēkā
68426ISO 10993-11:2017Biological evaluation of medical devices — Part 11: Tests for systemic toxicityStandarts spēkā
44050ISO 10993-13:2010Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devicesStandarts spēkā
64887ISO/TR 37137:2014Cardiovascular biological evaluation of medical devices — Guidance for absorbable implantsStandarts spēkā
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