ANSI Z80.30

Abstract

Scope and purpose This standard applies to any monofocal intraocular lens (IOL) whose primary indication is the reduction of astigmatism either with the correction of aphakia or the modification of the refractive power of a phakic eye. It does not include IOLs used to correct presbyopia. This standard addresses the vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device. As applies to any standard, alternative validated test methods may be used.