NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-10 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-1 | 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More |
| ISO 10993-12 | 2021-01 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials More |
| ISO 10993-18 | 2020-01 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process More |
| ISO 10993-2 | 2022-11 | Biological evaluation of medical devices - Part 2: Animal welfare requirements More |
| DIN EN ISO 10993-1 | 2021-05 | 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 |
| DIN EN ISO 10993-12 | 2021-08 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021 More |
| DIN EN ISO 10993-2 | 2023-02 | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022 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/IEC 17025 | 2018-03 | General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017 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 |
