DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 14534
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2011
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2011); Deutsche Fassung EN ISO 14534:2011
Overview
The standard specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. It has been prepared under a mandate of the European Commission for the purpose of concretization of the essential requirements according to EU Directive 93/42/EEC (Medical Device Directive). In this revision, an update of the normative references has been made. Furthermore, the requirements for the information for the product to be supplied by the manufacturer have been changed. The International Standard has been prepared by ISO/TC 172/SC 7 "Ophthalmic optics and instruments", in collaboration with CEN/TC 170 "Ophthalmic optics" (both secretariats: DIN, Germany). On the national level, the responsible Working Committee is NA 027-01-08 AA "Augenoptik" ("Ophthalmic optics"), Working Group "Kontaktlinsen" ("Contact lenses") at NAFuO.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 027-01-08-04 AK - Contact lenses
