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Publications of NA 027-07-12 AA

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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	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 10993-2	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 10993-3	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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