ISO/TC 194
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
88201 | ISO 10993-17:2023/FDAmd 1 | Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1 | Izstrādē |
41177 | ISO/WD 14155-2 | Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans | Izstrādē |
64780 | ISO/WD TS 29741 | Biological evaluation of medical devices — Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP) | Izstrādē |
90743 | ISO/AWI 10993-14 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics | Izstrādē |
84824 | ISO/DIS 10993-7 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals | Izstrādē |
63449 | ISO/CD 10993-5 | Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | Izstrādē |
90931 | ISO/CD TS 25364-2 | Analytical chemistry matters associated with ISO 10993-18 — Part 2: Quantification of medical device extractables and leachables using Non-Targeted Analysis (NTA) | Izstrādē |
90930 | ISO/CD TS 25364-1 | Analytical chemistry matters associated with 10993-18 — Part 1: Identification of organic medical device extractables and leachables in Non-Target Analysis (NTA) | Izstrādē |
35980 | ISO/WD TS 10993-21 | Biological evaluation of medical devices — Part 21: Guidelines for the preparation of standards for the biological evaluation of medical devices | Izstrādē |
64744 | ISO/PWI 10993-17 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances | Izstrādē |
Displaying 31-40 of 146 results.