NA 176
DIN Standards Committee Health Technologies
DIN 13097-4 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 9626 | 2016-12 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016 More |
| ISO 15510 | 2014-05 | Stainless steels - Chemical composition More |
| DIN EN ISO 10993-11 | 2018-09 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018 More |
| DIN EN ISO 10993-13 | 2010-11 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010 More |
| DIN EN ISO 10993-14 | 2009-08 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 More |
| DIN EN ISO 10993-16 | 2018-02 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017 More |
| DIN EN ISO 10993-3 | 2015-02 | 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 |
| DIN EN ISO 10993-4 | 2017-12 | 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 |
| DIN EN ISO 10993-5 | 2009-10 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009 More |
| DIN EN ISO 10993-6 | 2017-09 | 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 |
