ISO/TC 194

Registration number (WIID)Project No.TitleStatus
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 devicesAtcelts
31723ISO 14155-1:2003Clinical investigation of medical devices for human subjects — Part 1: General requirementsAtcelts
65052ISO/TR 10993-33:2015Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3Atcelts
71690ISO 14155:2020Clinical investigation of medical devices for human subjects — Good clinical practiceAtcelts
36405ISO 10993-2:2006Biological evaluation of medical devices — Part 2: Animal welfare requirementsAtcelts
34213ISO 10993-7:2008Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residualsAtcelts
68936ISO 10993-1:2018Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management processAtcelts
22694ISO 10993-15:2000Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloysAtcelts
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 infantsAtcelts
18970ISO/TR 10993-9:1994Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testingAtcelts
Displaying 41-50 of 159 results.