DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
Abstract
This part of IEC 60601 applies to the Basic Safety of Hearing Aids and Hearing Aid Systems. Accessories to hearing instruments in the home healthcare environment (e.g. remote control units, audio streamers, batter chargers, power supplies) can be tested according to the applicable standard IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable standards. Hearing instruments related to accessories, that in normal use not physically connected to the hearing instrument are not considered to be applied part, because they do not directly contribute to the intended use of the hearing instrument. This new edition includes significant technical changes with respect to the previous edition published in 2019-10. These include a revised document structure, new definitions, the revision of clauses related to acoustic energy, requirements for Direct-To-Consumer Hearing Aids and the concept of Sound Dose as optional safety feature were added. New Annexes EE and FF were added to describe verification of sound dose monitoring and warning and Sound Dose calculation an a summary of requirements and tests to products in the scope of IEC 60601-2-66 . This document does not address applicable testing for intentional RF radiation of wireless quipment (e.g. maximum radiated output power, modulation bandwidth, etc.).
Begin
2024-02-29
Planned document number
DIN EN IEC 60601-2-66
Project number
02232140
