• Hydrogen Technologies Standards form the basic framework for market ramp-up

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  • Climate change Standards and specifications support climate targets

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  • Smart Farming Standards and specifications are drivers for the digitalization of agriculture

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Projects of NA 027-07-12 AA

Document number Begin Title Comment
ISO/AWI TS 26177 2025-11-03 Biological evaluation of medical devices - Guidance on risk estimation in the application of ISO 10993-1” More  Comment 
ISO/AWI TS 21726 2025-10-09 Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents 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/CD TS 25364-1 2024-11-14 Chemical Characterization of Medical Devices - Part 1: Identification of Organic Extractables in Non-Targeted Analysis (NTA) More  Comment 
DIN EN ISO 10993-14 rev 2024-11-04 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics More  Comment 
DIN EN ISO 10993-13 rev 2024-11-04 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices More  Comment 
DIN EN ISO 10993-4 rev 2024-11-04 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood More  Comment 

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