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