ISO/TC 194

Registration number (WIID)Project No.TitleStatus
64780ISO/WD TS 29741Biological evaluation of medical devices — Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP)Izstrādē
90037ISO/WD TS 25364Discovery, Identification and Quantification of Medical Device Extractables and Leachables via Non-Target Analysis (NTA) — Analytical Chemistry Matters Associated with ISO 10993-18Izstrādē
35980ISO/WD TS 10993-21Biological evaluation of medical devices — Part 21: Guidelines for the preparation of standards for the biological evaluation of medical devicesIzstrādē
41177ISO/WD 14155-2Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plansIzstrādē
64763ISO/WD 10993-7Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residualsIzstrādē
50994ISO/WD 10993-4Biological evaluation of medical devices — Part 4: Selection of tests for interactions with bloodIzstrādē
90744ISO/WD 10993-4Biological evaluation of medical devices — Part 4: Selection of tests for interactions with bloodIzstrādē
36404ISO/WD 10993-1Biological evaluation of medical devices — Part 1: Evaluation and testingIzstrādē
73582ISO/TS 37137-1:2021Biological evaluation of absorbable medical devices — Part 1: General requirementsStandarts spēkā
71514ISO/TS 21726:2019Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituentsStandarts spēkā
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