DIN EN ISO 14534:2011-06

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.