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 10993-9 | 2021-09 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) More |
| EN ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) More |
| EN ISO 139 | 2005-01 | Textiles - Standard atmospheres for conditioning and testing (ISO 139:2005) More |
