DIN Standards Committee Health Technologies
DIN EN ISO 14534
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2015
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen (ISO 14534:2011); Deutsche Fassung EN ISO 14534:2015
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). It was prepared under a mandate from the European Commission for the purpose of specifying the basic requirements according to the EU Directive 93/42/EEC (Medical Devices Directive). In this new publication of the standard, a table has been included on the correspondence between undated normative references and dated EN and ISO standards and Annex ZA has been updated. 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.
