Projects of ISO/TC 194/WG 14

Document number Begin Title Comment
ISO/AWI TS 11967 2026-06-23 Biological evaluation of medical devices - Guidance on commissioning scientifically robust chemical characterization testing in accordance with ISO 10993-18 More  Comment 
ISO/AWI TS 25364-4 2025-09-17 Analytical chemistry matters associated with ISO 10993-18 - Part 4: Critical aspects of extract viability in extractables and leachables testing using non-targeted analysis (NTA) More  Comment 
ISO/CD TS 20324 2025-05-09 Generation of medical device extracts for chemical analysis to support toxicological risk assessment More  Comment 
ISO/CD TS 25364-3 2024-11-14 Analytical chemistry matters associated with ISO 10993-18 - Part 3: Instrumental and human requirements for evaluating organic medical device extractables and leachables via Non-Targeted Analysis (NTA) More  Comment 
ISO/CD TS 25364-2 2024-11-14 Analytical chemistry matters associated with ISO 10993-18 - Part 2: Quantification of medical device extractables and leachables using Non-Targeted Analysis (NTA) More  Comment 
ISO/DTS 25364-1 2024-11-14 Chemical characterization of medical devices - Part 1: Identification of organic extractables in Non-Targeted Analysis (NTA) More  Comment 

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