• 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

ISO/DIS 10993-2 2023-10-27 Biological evaluation of medical devices - Part 2: Animal welfare requirements More  Comment 
ISO/WD 10993-16 2023-10-27 Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables More  Comment 
ISO/CD 10993-3 2023-10-27 Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity More  Comment 
ISO 10993-23 DAM 1 2023-10-27 Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models More  Comment 
DIN EN ISO 10993-4/A1 2023-04-27 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024 More  Comment 
DIN EN ISO 10993-11 rev 2023-04-25 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity More  Comment 
ISO/CD 10993-11 2023-04-18 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity More  Comment 
ISO 10993-4 PRF AMD 1 2023-04-17 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 More  Comment 
DIN EN ISO 10993-6 2023-01-27 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024 More  Comment 
ISO/DIS 14155 2022-12-12 Clinical investigation of medical devices for human subjects - Good clinical practice More  Comment 

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