Publications of NA 027-07-12 AA

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 Beuth Verlag
DIN EN ISO 10993-2 2020-04 Draft standard Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2020); German and English version prEN ISO 10993-2:2020 More  Order from Beuth Verlag
DIN EN ISO 10993-2 2006-10 Standards Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006); German version EN ISO 10993-2:2006 More  Order from Beuth Verlag
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 Beuth Verlag
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 Beuth Verlag
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 Beuth Verlag
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 Beuth Verlag
DIN EN ISO 10993-7 2022-09 Standards Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022 More  Order from Beuth Verlag
DIN EN ISO 10993-9 2022-03 Standards Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:2021 More  Order from Beuth Verlag
DIN EN ISO 10993-10 2020-04 Draft standard Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/DIS 10993-10:2020); German and English version prEN ISO 10993-10:2020 More  Order from Beuth Verlag

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