• 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 10993-4 2024-10-29 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood More  Comment 
DIN EN ISO 10993-17/A1 2023-11-17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAM 1:2024); German and English version EN ISO 10993-17:2023/prA1:2024 More  Comment 
DIN EN ISO 10993-23/A1 2023-11-14 Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/DAM 1:2024); German and English version EN ISO 10993-23:2021/prA1:2024 More  Comment 
DIN EN ISO 10993-2 2023-11-14 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2024); German and English version prEN ISO 10993-2:2024 More  Comment 
DIN EN ISO 10993-16 rev 2023-11-14 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables More  Comment 
DIN EN ISO 10993-3 2023-11-14 Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025); German and English version prEN ISO 10993-3:2025 More  Comment 
DIN EN ISO 10993-12/A1 2023-11-14 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - AMENDMENT 1 (ISO 10993-12:2021/FDAM 1:2025); German and English version EN ISO 10993-12:2021/FprA1:2025 More  Comment 
ISO/AWI TR 24850 2023-10-31 Sources of hazard information for medical device constituents More  Comment 
ISO/DIS 10993-3 2023-10-27 Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity More  Comment 
ISO/CD 10993-16 2023-10-27 Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables More  Comment 

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