DIN EN ISO 11979-7:2012-05
Title (german): Ophthalmische Implantate - Intraokularlinsen - Teil 7: Klinische Prüfungen (ISO 11979-7:2006 + Amd 1:2012); Deutsche Fassung EN ISO 11979-7:2006 + A1:2012
Title (english): Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006 + Amd 1:2012); German version EN ISO 11979-7:2006 + A1:2012
Document type: Standard
Publication date: 2012-05
The standard specifies particular requirements for clinical investigations for posterior and anterior chamber monofocal intraocular lenses which serve for correction of aphakia. It is part of a comprehensive standard series DIN EN ISO 11979 for intraocular lenses. The standard is directed at experts carrying out clinical investigations on intraocular lenses, especially among manufacturers and test laboratories. Within the framework of the currently available Amendment A1 of DIN EN ISO 11979-7:2006-07, Annex B "Evaluation of post-operative adverse event and visual acuity rates" has been modified. Amendment A1 to the standard DIN EN ISO 11979-7:2006-07 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.