DIN EN ISO 11979-7:2024-06

Intraocular lenses (IOLs) are used to correct residual refractive errors in subjects who have aphakia. Such residual refractive errors typically include sphere and astigmatism but may also correct for a lack of accommodation. Different designs of IOLs can be used to correct for specific refractive errors. In the case where an IOL is designed to provide more than one type of refractive correction, that IOL will have to satisfy each of the separate requirements of those correction designs. This document provides requirements and recommendations for intraocular lens investigations of new IOL models. In the case where an IOL model is a modification of a parent IOL model, a risk analysis can be used in order to determine the appropriate level of testing. This document has been prepared by Technical Committee ISO/TC 172/SC 7 "Ophthalmic optics and instruments", in collaboration with CEN/TC 170 "Ophthalmic optics" (both secretariats: DIN, Germany). The responsible German standardization committee is Working Committee NA 027-01-20 AA "Intraokulare Medizinprodukte" ("Intraocular medical devices") at DIN Standards Committee Optics and Precision Mechanics (NAFuO).