ČSN EN ISO 11979-10   (195300) Oftalmologické implantáty - Nitrooční čočky - Část 10: Klinické zkoušky nitroočních čoček pro nápravu ametropie u fakických očí

Anotace textu normy ČSN EN ISO 11979-10   (195300)

This document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main categories of phakic intraocular lenses depending on the optical design:

a) Phakic monofocal (PIOL),

b) Phakic multifocal (PMIOL), and

c) Phakic toric (PTIOL).

Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye.

The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs.

This document addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.