NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-16 | 2017-05 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables More |
| ISO 10993-2 | 2022-11 | Biological evaluation of medical devices - Part 2: Animal welfare requirements More |
| ISO 10993-23 | 2021-01 | Biological evaluation of medical devices - Part 23: Tests for irritation More |
| ISO 10993-3 | 2014-10 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity More |
| ISO 10993-4 | 2017-04 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood More |
| ISO 10993-5 | 2009-06 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity More |
| ISO/TS 10993-19 | 2020-03 | Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials More |
| EUV 2017/745 | 2017-04-05 | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC More |
| ISO 11737-3 | 2023-06 | Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
