The IEC 60601-2-66 standard, published by the International Electrotechnical Commission (IEC), describes the requirements for evaluating the basic safety and basic performance of hearing aids and hearing aid systems.
First of all, a standard study was conducted by the European hearing aid manufacturers association in order to provide manufacturers with a guide to prove compliance with the European medical devices directive numbered 93/42/EEC. However, the draft was not approved by CENELEC, it was still published. In 2009, this study was reconsidered by IEC or ISO and the internationally accepted IEC 60601 standard for hearing aid safety emerged.
This standard does not cover:
This standard does not address applicable tests for intentional radio frequency radiation (for example, maximum radiated output power or modulation bandwidth) of wireless equipment.
In the IEC 60601 series, certain standards can replace or delete requirements contained in the general standard, create complementary standards suitable for the hearing aid in question, and add other essential safety and essential performance requirements. The requirement of a particular standard takes precedence over the general standard.
The latest update to the IEC 60601-2-66 standard includes the following technical changes:
Our organization, among the numerous test, measurement, analysis and evaluation studies it has given for businesses in various sectors, with its trained and expert staff and advanced technological equipment, aims to determine the basic safety and basic performance of hearing aids and hearing aid systems within the scope of IEC 60601-2-66 standard. It also provides testing services for
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
