Abstract

This document contains requirements and guidance for the labelling of intraocular lenses and the information supplied with them. Labelling requirements for medical devices in general are given in ISO 20417. However, in order to ensure correct and necessary information to the ophthalmic surgeon, some additional information is required for intraocular lenses. This information concerns technical and optical data as well as information about materials used. This revision provides new requirements and recommendations for intraocular lens labeling that do not have to be applied to IOLs that have been already approved before publication of this document. The document was prepared by ISO/TC 172/SC 7 "Ophthalmic optics and ophthalmic instruments" (Secretariat: DIN, Germany) with German participation. Within DIN, the working committee NA 027-01-20 AA "Intraokulare Medizinprodukte" in NAFuO is responsible for this.

Begin

2022-12-11

WI

00170316

Planned document number

DIN EN ISO 11979-4

Project number

02703390

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 4: Labelling and information (ISO/DIS 11979-4:2024); German and English version prEN ISO 11979-4:2024
2024-10
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previous edition(s)

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008 + Amd.1:2012); German version EN ISO 11979-4:2008 + A1:2012
2013-01

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