This part of ISO 11979 specifies requirements and test methods for certain optical properties of intraocular lenses with any of the spherical, aspherical, monofocal, toric, multifocal, or matched optics. The generic descriptor 'IOL' used in this document also includes phakic intraocular lenses.
The manufacturer must demonstrate that all available powers meet the specifications herein. All optical properties are applied to in situ conditions, either by measuring in simulated in situ conditions or by measuring in other conditions and then correcting for in situ conditions.
For IOLs intended to deform the optic during implantation, dioptric power and imaging quality must be demonstrated to be maintained in situ or equivalent following surgical manipulation and healing.
The test methods described in this standard are reference methods. If the manufacturer can demonstrate that the IOLs meet the minimum dioptric power and imaging quality requirements, alternative methods may be used that produce results equivalent to those obtained with reference methods.
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