The IEC 60601-2-66 standard, prepared by the International Electrotechnical Commission (IEC), an organization affiliated to the International Organization for Standardization (ISO), describes the basic safety and performance criteria for hearing aids and hearing aid systems.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-66 Electrical medical equipment - Part 2-66: Basic safety and instruments, hearing and hearing aids and special rules for basic performance.
In the last update made in 2019, the definition of basic performance was revised, the application of the IEC 60601-1-2 standard for electromagnetic disturbances was revised, the voltage used for hearing aids was corrected between 1,6 volts and 4,5 volts, and the drop test level was 1,5, It was reduced from 1 meters to XNUMX meter.
Hearing aid accessories used in the home environment, such as remote control units, audio streaming devices, battery chargers and power supplies, are tested according to IEC 60065, IEC 60950-1, IEC 62368-1 and other applicable safety standards.
Equipment outside the scope of this standard are: implant hearing aids, bone conduction hearing aids, educational hearing aids, application of a hearing aid for measuring hearing levels (in this case IEC 60645-1 standard applies), installed sound frequency induction loop systems or component parts and ear the sound generating function of the ringing mask.
Hearing aids are electronic devices that properly amplify sounds that are difficult for people with hearing loss to hear. Today The hearing aids produced are tiny computer systems equipped with advanced technologies. These devices not only amplify the sound but also show the ability to distinguish sound in noisy environments.
Tests in accordance with IEC 60601-2-66 standard are also carried out by our organization within the scope of medical device tests.
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