ISO/TC 194

Registration number (WIID)Project No.TitleStatus
64581ISO/PWI 10993-13Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devicesIzstrādē
64580ISO 10993-9:2019Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation productsStandarts spēkā
64238ISO/DTR 17137-2Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants — Part 2: Guidance on biological evaluation of absorbable implantsIzstrādē
63449ISO/CD 10993-5Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicityIzstrādē
63448ISO 10993-4:2017Biological evaluation of medical devices — Part 4: Selection of tests for interactions with bloodStandarts spēkā
61089ISO 10993-6:2016Biological evaluation of medical devices — Part 6: Tests for local effects after implantationStandarts spēkā
59992ISO 14155:2011/Cor 1:2011Clinical investigation of medical devices for human subjects — Good clinical practice — Technical Corrigendum 1Atcelts
56669ISO 10993-1:2009/Cor 1:2010Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process — Technical Corrigendum 1Atcelts
55614ISO 10993-3:2014Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicityStandarts spēkā
55441ISO/TR 15499:2012Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management processAtcelts
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