DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-2-66
; VDE 0750-2-66:2015-08
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems (IEC 60601-2-66:2012); German version EN 60601-2-66:2013
Medizinische elektrische Geräte - Teil 2-66: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hörgeräten und Hörgerätesystemen (IEC 60601-2-66:2012); Deutsche Fassung EN 60601-2-66:2013
Overview
This International Standard applies to the basic safety of hearing aids and hearing aid systems in conjunction with other standards of the DIN EN 60601 series of edition 3.0. It is the first international edition of this standard and provides the manufacturers of hearing aids with the basis to market their products worldwide. This standard does not apply to: cochlear implants or other implanted hearing instruments, bone conduction hearing instruments, the sound generating function of a tinnitus masker, group hearing instruments, auditory trainers. The committee responsible for this standard is NA 016-00-06 AA "Flüssiggas-Geräte und Ausrüstung; Spiegelausschuss zu CEN/TC 286" ("Liquefied petroleum gas equipment and accessories; Mirror Committee of CEN/TC 286") at DIN Standards Committee Acoustics, Noise Control and Vibration Engineering (NDG) of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
