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ANSI Z80.13-2007 (R2017) 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.
Product Details
- Published:
- 2007
- Number of Pages:
- 44
- File Size:
- 1 file , 440 KB
