NF EN ISO 11979-7

<p>ISO 11979-7:2014 specifies particular requirements for clinical investigations for posterior and anterior chamber intraocular lenses (IOLs). </p>

<p>ISO 11979-9:2006 is applicable to any intraocular lens whose optic provides two or more rotationally symmetric powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near).</p> <p>The term "near vision" as used in ISO 11979-9:2006 includes useful vision at a distance of claimed benefit; e.g. near and/or intermediate distances.</p>

Le présent document amende la norme homologuée NF EN ISO 11979-9:2006 par une mise à jour des articles 1 (domaine d'application), 2 (références normatives), 3 (termes et définitions), 4 (exigences physiques), 5 (exigences optiques), 6 (investigation clinique) et 7 (informations fournies par le fabricant), ainsi que l'annexe A (qualification optique).

<p class="MsoBodyText"><span lang="EN-GB">This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.</span></p>