DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 11979-8
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2015
Ophthalmische Implantate - Intraokularlinsen - Teil 8: Grundlegende Anforderungen (ISO 11979-8:2006 + Amd.1:2011); Deutsche Fassung EN ISO 11979-8:2015
Overview
The standard specifies fundamental requirements for intraocular lenses. It refers to the other parts of the standard series DIN EN ISO 11979 for intraocular lenses regarding special properties or test methods. The standard is directed at all experts dealing with intraocular lenses, especially among manufacturers and test laboratories. In this new edition Amendment A1 to DIN EN ISO 11979-8:2009-08 has been incorporated with requirements regarding bacterial endotoxins (Subclause 9.2) and the changes initiated by CEN in Annex ZA on the connection between this International Standard and the essential requirements of EU Directive 93/42/EEC have been updated. The standard DIN EN ISO 11979-8:2011-09 has been prepared by ISO/TC 172/SC 7 "Ophthalmic optics and instruments" (secretariat: DIN, Germany) with German collaboration. The responsible committee at DIN is Working Committee NA 027-01-20 AA "Intraokulare Medizinprodukte" ("Intraocular medical devices") at NAFuO.
