ISO/TC 194

Registration number (WIID)Project No.TitleStatus
44050ISO 10993-13:2010Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devicesStandarts spēkā
64750ISO 10993-18:2020Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management processStandarts spēkā
68426ISO 10993-11:2017Biological evaluation of medical devices — Part 11: Tests for systemic toxicityStandarts spēkā
35979ISO/TS 10993-20:2006Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devicesStandarts spēkā
84824ISO 10993-7:2026Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residualsStandarts spēkā
64582ISO 10993-16:2017Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachablesStandarts spēkā
83976ISO 10993-6:2026Biological evaluation of medical devices — Part 6: Tests for local effects after implantationStandarts spēkā
83968ISO 14155:2026Clinical investigation of medical devices for human subjects — Good clinical practiceStandarts spēkā
64580ISO 10993-9:2019Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsStandarts spēkā
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
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