DIN EN ISO 15798:2014-02

This standard specifies requirements with regard to the safety of ophthalmic viscosurgical devices for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices and related test methods. In this regard, it is primarily directed at manufacturers of those products and experts dealing with their development and testing. Compared to the 2010 edition, the normative references, Table 1 on information to be supplied by the manufacturer, Annex ZA on the relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC have been updated. This International Standard has been revised by ISO/TC 172/SC 7 "Ophthalmic optics and instruments" (secretariat: DIN, Germany) with German collaboration. At DIN, Working Committee NA 027-01-20 AA "Intraokulare Medizinprodukte" ("Intraocular medical devices") at NaFuO is responsible