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Publications of CEN/TC 206

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 10993-17 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
DIN EN ISO 14155 2021-05 Standards Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020 More  Order from DIN Media
DIN EN ISO 22442-1 2021-08 Standards Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020 More  Order from DIN Media
DIN EN ISO 22442-2 2021-04 Standards Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020 More  Order from DIN Media

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