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Publications of CEN/TC 206

DIN EN ISO 10993-1 2024-07 Draft standard 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  Order from DIN Media
DIN EN ISO 10993-1 2021-05 Standards Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 More  Order from DIN Media
DIN EN ISO 10993-2 2024-12 Draft standard 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  Read draft and comment
DIN EN ISO 10993-2 2023-02 Standards Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022 More  Order from DIN Media
DIN EN ISO 10993-3 2015-02 Standards Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014 More  Order from DIN Media
DIN EN ISO 10993-4 2017-12 Standards Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017 More  Order from DIN Media
DIN EN ISO 10993-4/A1 2024-04 Draft standard 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  Order from DIN Media
DIN EN ISO 10993-5 2009-10 Standards Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009 More  Order from DIN Media
DIN EN ISO 10993-6 2024-06 Draft standard 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  Order from DIN Media
DIN EN ISO 10993-6 2017-09 Standards Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016 More  Order from DIN Media

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