What is IEC 60601-2-66- Hearing aids and hearing aid systems safety performance about?
IEC 60601-2-66 applies to the basic safety of hearing aids and hearing systems,
hereafter also referred to as me equipment or my system. Accessories with functional connections to a hearing aid may form a hearing aid system. Wireless programming interfaces are covered by IEC 60601-2-66. Programming interfaces with a wired connection to the HEARING AID are covered by IEC 60601-2-66.
NOTE 1: Detachable parts of HEARING AIDS, even if supplied separately (e.g., ear hooks, domes, wax guards, etc.), are not considered as accessories, but as component parts
NOTE 2: IEC 60601-2-66 does not apply to:
- Cochlear implants or other implanted HEARING AIDS
- Bone conduction HEARING AIDS
- Educational HEARING AIDS (i.e., group HEARING AIDS, auditory trainers, etc.)
- The application of a HEARING AID for the measurement of hearing levels
- Fix installed audio-frequency induction-loop systems or their component parts
- The sound generating function of a tinnitus masker
NOTE 3: IEC 60601-2-66 does not address applicable testing for intentional RF radiation of wireless equipment (e.g., maximum radiated output power, modulation bandwidth, etc.)
Who is IEC 60601-2-66- Hearing aids and hearing aid systems safety performance for?
IEC 60601-2-66 on the requirements for the basic safety and essential performance of hearing aids and hearing aid systems is beneficial for:
- Audiologists
- Manufacturers of hearing aids
Why should you use IEC 60601-2-66- Hearing aids and hearing aid systems safety performance?
A hearing aid is a small electronic device that you wear in or behind your ear. It makes some sounds louder so that a person with hearing loss can listen, communicate and participate more fully in daily activities.
IEC 60601-2-66 specifies requirements to provide protection against electric shock, particularly regarding allowable patient leakage current and patient auxiliary current. IEC 60601-2-66 provides devices that pickup sound and deliver processed sound to the ear canal through air conduction. After the hearing aid or hearing aid system to be tested has been set up for normal use, tests are performed within the range of environmental conditions indicated in the technical description, as specified by the manufacturer. The humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative humidity of 93 % ± 3 % where the ME EQUIPMENT or its parts under test are located.
Overall, IEC 60601-2-66 is helpful as it provides hearing aids that have an enclosure or a part of the enclosure made of insulating material, metal foil, is applied in intimate contact with the enclosure or relevant part of the enclosure. Cables and lanyards of hearing aids or accessories worn by the patient around the neck do not pose a risk of injury or strangulation.
What’s changed since the last update?
BS EN IEC 60601-2-66:2020 supersedes BS EN 60601‑2‑66:2015, which is withdrawn.
BS EN IEC 60601-2-66:2020 cancels and replaces the second edition published in 2015. It constitutes a technical revision.
BS EN IEC 60601-2-66:2020 includes the following significant technical changes with respect to the previous edition:
- Revision of the definition of essential performance
- Revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances
- Correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V
- Correction of the drop test level from 1,5 m to 1,0 m
- Correction of the wording of IEC 60601-2-66:2015
