NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 11979-5 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-12 | 2021-01 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials More |
| ISO 10993-3 | 2014-10 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity More |
| ISO 10993-5 | 2009-06 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity More |
| ISO 11979-3 | 2012-12 | Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 18369-4 | 2017-08 | Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials More |
| ISO/TR 22979 | 2017-05 | Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications More |
| ISO/TS 21726 | 2019-02 | Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents More |
| DIN EN ISO 10993-3 | 2015-02 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014 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 |