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Description / Abstract:
Scope and purpose
This standard applies to any intraocular lens (IOL) whose
primary indication is the modification of the refractive power of a
phakic eye. It does not include IOLs used to correct presbyopia or
astigmatism.
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.