• 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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Publications of CEN/TC 206

DIN EN ISO 10993-14 2009-08 Standards Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 More  Order from DIN Media
DIN EN ISO 10993-15 2023-07 Standards Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019); German version EN ISO 10993-15:2023 More  Order from DIN Media
DIN EN ISO 10993-16 2018-02 Standards Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017 More  Order from DIN Media
DIN EN ISO 10993-16 2025-12 Draft standard Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables (ISO/DIS 10993-16:2025); German and English version prEN ISO 10993-16:2025 More  Read draft and comment
DIN EN ISO 10993-17 2024-02 Standards Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023 More  Order from DIN Media
DIN EN ISO 10993-17/A1 2024-09 Draft standard 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  Order from DIN Media
DIN EN ISO 10993-18 2023-11 Standards Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023 More  Order from DIN Media
DIN EN ISO 10993-23 2021-10 Standards Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021 More  Order from DIN Media
DIN EN ISO 10993-23/A1 2024-10 Draft standard 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  Order from DIN Media
DIN EN ISO 14155 2024-09 Draft standard Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024 More  Order from DIN Media

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