ISO/TC 194

Registration number (WIID)Project No.TitleStatus
64750ISO 10993-18:2020Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management processStandarts spēkā
64582ISO 10993-16:2017Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesStandarts spēkā
83968ISO 14155:2026Clinical investigation of medical devices for human subjects — Good clinical practiceStandarts spēkā
65918ISO/TR 10993-22:2017Biological evaluation of medical devices — Part 22: Guidance on nanomaterialsStandarts spēkā
68426ISO 10993-11:2017Biological evaluation of medical devices — Part 11: Tests for systemic toxicityStandarts spēkā
64580ISO 10993-9:2019Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsStandarts 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
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
71150ISO/TR 21582:2021Pyrogenicity — Principles and methods for pyrogen testing of medical devicesStandarts spēkā
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