NA 176

DIN Standards Committee Health Technologies

DIN EN 14683 [CURRENT] references following documents:

Document number Edition Title
EN ISO 10993-18 2020-05 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) More 
EN ISO 10993-18/A1 2023-07 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022) More 
EN ISO 10993-2 2022-11 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022) More 
EN ISO 10993-23 2021-03 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) More 
EN ISO 10993-3 2014-10 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) More 
EN ISO 10993-4 2017-10 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) More 
EN ISO 10993-5 2009-06 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) More 
EN ISO 10993-6 2016-12 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016) More 
EN ISO 10993-7 2008-10 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) More 
EN ISO 10993-7/AC 2009-11 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009) More