ANSI Z80.35-2018

ANSI Z80.35-2018 applies to intraocular lenses (IOLs) whose function is the correction of aphakia, with extended range of focus above a defined functional visual acuity threshold to provide useful distance and intermediate vision with monotonically decreasing visual acuity from the best distance focal point. This standard addresses specific requirements for Extended Depth of Focus Intraocular Lenses (EDF IOLs) that are not addressed in the normative references, and include 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 with any standard, alternative validated test methods may be used.