ISO 11979-10:2018

Ophthalmic implants — Intraocular lenses — Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes

Publication date:   Mar 23, 2018

General information

90.20 Standard under periodical review   Jan 15, 2023

ISO

ISO/TC 172/SC 7 Ophthalmic optics and instruments

International Standard

11.040.70   Ophthalmic equipment

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Scope

ISO 11979-10:2018 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.
ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.

Life cycle

PREVIOUSLY

Revises
ISO 11979-10:2006

Revises
ISO 11979-10:2006/Amd 1:2014

NOW

PUBLISHED
ISO 11979-10:2018
90.20 Standard under periodical review
Jan 15, 2023