Cover DIN EN IEC 60601-2-66 VDE 0750-2-66:2020-09
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DIN EN IEC 60601-2-66 VDE 0750-2-66:2020-09

* German Language Version *

Medical electrical equipment

Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems

(IEC 60601-2-66:2019); German version EN IEC 60601-2-66:2020
Class/Status: Standard, valid
Released: 2020-09
VDE Art. No.: 0701264

This International Standard applies to the satefy of hearing instruments and hearing instrument 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. Accessories with a functional connection to a hearing instrument may form a hearing instrument system. Hearing instruments related to accessories, that in normal use not ohysically 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 standard does not apply to:
Cochlear implants or other implanted hearing instruments, Bone conduction hearing instruments, educational hearing instruments (i.e. group hearing instruments, auditory trainers etc.), the application of a hearing instrument for the measurement of hearing levels, fix installed audio-frequency induction loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1, the sound generating function of a tinnitus masker.

Recommended books about this Standard

Title Format
Entwicklung und Herstellung medizinischer Software
Prinz, Thorsten (Hrsg.)

Entwicklung und Herstellung medizinischer Software

Normen in der Medizintechnik
VDE-Schriftenreihe – Normen verständlich, Band 171

2017, 219 pages, Din A5, Broschur

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