Norm

NEN-EN-ISO 11979-10:2018 en

Oogheelkundige implantaten - Intra-oculaire lenzen - Deel 10: Klinisch onderzoek van intra-oculaire lenzen voor correctie van ametropie in phake ogen

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Over deze norm

Status Definitief
Aantal pagina's 17
Commissie Intra-oculaire lenzen en contactlenzen
Gepubliceerd op 01-05-2018
Taal Engels
NEN-EN-ISO 11979-10 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.

Details

ICS-code 11.040.70
Nederlandse titel Oogheelkundige implantaten - Intra-oculaire lenzen - Deel 10: Klinisch onderzoek van intra-oculaire lenzen voor correctie van ametropie in phake ogen
Engelse titel Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
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