DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 80601-2-58
; VDE 0750-2-58:2015-11
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (IEC 80601-2-58:2014); German version EN 80601-2-58:2015
Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Geräte zur Linsenentfernung und Geräte zur Glaskörperentfernung in der Augenchirurgie (IEC 80601-2-58:2014); Deutsche Fassung EN 80601-2-58:2015
Overview
Lens removal devices (lensectomy devices) and vitreous body removal devices (vitrectomy devices) are widely used in ophthalmology to perform anterior-segment and posterior-segment surgery on the human eye. Commercial application of these medical electrical devices began after 1970. This International Standard defines particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices, comprising an equipment console, surgical handpieces, and accessories connected to this medical electrical equipment. In many parts of the world lens removal devices and vitrectomy devices are used in combination by ophthalmic surgeons to perform combined anterior-segment (lens removal) and posterior-segment (vitreoretinal) surgical procedures to maximize surgical outcomes. For this reason both lens removal devices and vitrectomy devices are covered in this International Standard. The responsible committee is DKE/UK 812.2 "Therapie, Chirurgie" ("Therapy, surgery") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
