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

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Projects of CEN/TC 206

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 
DIN EN ISO 21762 2023-10-19 Medical devices utilizing human tissues and their derivatives - Application of risk management 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/Amd 1:2025); German version EN ISO 10993-4:2017/A1:2025 More  Comment 
DIN EN ISO 10993-11 2023-04-25 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2025); German and English version prEN ISO 10993-11:2025 More  Comment 
DIN EN ISO 18969 2023-02-22 Clinical evaluation of medical devices 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 
DIN EN ISO 8250 2022-06-07 Cleanliness of medical devices - Process design and test methods More  Comment 
DIN EN ISO 10993-7 2022-03-29 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024 More  Comment 
DIN EN ISO 10993-1 2022-02-03 Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024 More  Comment 

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