Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024); German version EN ISO 11979-7:2024
Abstract
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. Intraocular lenses (IOLs) are used to correct residual refractive errors in subjects who have aphakia. Such residual refractive errors typically include sphere and astigmatism but may also correct for a lack of accommodation. Different designs of IOLs can be used to correct for specific refractive errors. In the case where an IOL is designed to provide more than one type of refractive correction, that IOL will have to satisfy each of the separate requirements of those correction designs. This document provides requirements and recommendations for intraocular lens investigations of new IOL models. In the case where an IOL model is a modification of a parent IOL model, a risk analysis can be used in order to determine the appropriate level of testing. This document was prepared by the Technical Committee ISO/TC 172 "Optics and photonics" of the "International Organization for Standardization" (ISO) in cooperation with the Technical Committee CEN/TC 170 "Ophthalmic optics" (both secretariats: DIN, Germany). The responsible German standardization body is the working committee NA 027-01-20 AA "Intraocular medical devices" in the DIN standards committee for precision mechanics and optics (NAFuO).
Begin
2019-10-31
WI
00170301
Planned document number
DIN EN ISO 11979-7
Project number
02703250
Responsible national committee
NA 027-01-20 AA - Intraocular medical devices
Responsible european committee
CEN/TC 170 - Ophthalmic optics
Responsible international committee
ISO/TC 172/SC 7/WG 7 - Ophthalmic implants
draft standard
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO/DIS 11979-7:2023); German and English version prEN ISO 11979-7:2023
2023-04
Order from DIN Media
