NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 22442-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 722/2012 | 2012-08-08 | Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin 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 10993-13 | 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 10993-16 | 2017-05 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables 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 |
