NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-12 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-1 | 2025-11 | Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process 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 14971 | 2019-12 | Medical devices - Application of risk management to medical devices 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 Guide 30 | 2015-02 | Reference materials - Selected terms and definitions More |
| ISO 10993-10 | 2021-11 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization More |
| ISO 10993-11 | 2017-09 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity More |
| ISO 10993-12 | 2021-01 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials More |
| ISO 10993-12 AMD 1 | 2025-08 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 More |
