UNE EN ISO 11979-10:2018
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018) (Endorsed by Asociación Española de Normalización in June of 2018.)
Implantes oftálmicos. Lentes intraoculares. Parte 10: Investigaciones clínicas de lentes intraoculares para la corrección de la ametropía en los ojos fáquicos (ISO 11979-10:2018) (Ratificada por la Asociación Española de Normalización en junio de 2018.)
| Označení normy: | UNE EN ISO 11979-10:2018 |
| Počet stran: | 27 |
| Vydáno: | 2018-06-01 |
| Status: | Norma |
UNE EN ISO 11979-10:2018
This document specifies particular requirements for any intraocular lenses to be implanted in the anterior segment of the eye whose primary indication is the modification of the refractive power of the phakic eye. There are three main categories of phakic intraocular lenses depending on the optical design: a) Phakic monofocal (PIOL) b) Phakic multifocal (PMIOL) c) Phakic toric (PTIOL) Each of these categories is further designated for implantation in either the anterior or posterior chamber 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 requirements for phakic IOLs not addressed in the other parts of ISO 11979.