DIN EN 80601-2-58 VDE 0750-2-58:2015-11

This International Standard defines particular requirements for basic safety and esssential 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.