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