DIN Standards Committee Optics and Precision Mechanics
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information
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
