NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-18 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 14971 | 2022-04 | Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More |
| DIN EN ISO 22442-1 | 2021-08 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020 More |
| DIN EN ISO 22442-2 | 2021-04 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020 More |
| DIN EN ISO 22442-3 | 2008-03 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007 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 10993-12 | 2021-01 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials More |
| ISO 10993-13 | 2010-06 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices More |
| ISO 10993-14 | 2001-11 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics More |
| ISO 10993-15 | 2019-11 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys More |
| ISO 10993-2 | 2022-11 | Biological evaluation of medical devices - Part 2: Animal welfare requirements More |
