DIN EN ISO 11979-8:2017-08

This part of ISO 11979 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants. These requirements include requirements for the safety and performance of the IOL, optical and mechanical properties, biocompatibility, manufacture, sterilization as well as information on clinical testing, packaging and shelf life and labelling and documentation. This document specifies the relevant requirements of EU Directive 93/42/EEC on medical devices. This document (prEN ISO 11979-8:2017) has been prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments, in collaboration with CEN/TC 170 Ophthalmic optics, the secretariat of which is held by DIN (Germany). The responsible German committee is Working Committee NA 027-01-20 AA "Intraokulare Medizinprodukte" ("Intraocular medical devices") at DIN Standards Committee Optics and Precision Mechanics (NAFuO).