CEI EN IEC 60601-2-66
Medical electrical equipment Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
|Publication Date:||1 July 2020|
|ICS Code (Aids for deaf and hearing impaired people):||11.180.15|
|ICS Code (Electroacoustics):||17.140.50|
This part of IEC 60601 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.
If a clause or subclause is specifically intended to be applicable to HEARING AIDS only, or to HEARING AID SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to HEARING AIDS and to HEARING AID SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of HEARING AIDS or HEARING AID SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 18.104.22.168 and 201.9.6.
NOTE See also 4.2 of the general standard.
ACCESSORIES to HEARING AIDS in the HOME HEALTHCARE ENVIRONMENT (e.g. remote control units, audio streamers, battery chargers, power supplies) can be tested according to the applicable standard, IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied. HEARING AIDS do not have a MAINS PART intended for connection to AC SUPPLY MAINS. The connection to the SUPPLY MAINS of a HEARING AID SYSTEM is covered by power supply, charger or other types of ACCESSORIES.
ACCESSORIES with FUNCTIONAL CONNECTION to a HEARING AID may form a HEARING AID SYSTEM. HEARING AID related ACCESSORIES that are not physically connected to the HEARING AID during NORMAL USE are not considered to be APPLIED PART, because they do not directly contribute to the INTENDED USE of the HEARING AID.
Wireless programming interfaces are covered by the applicable standard IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied.
Programming interfaces with wired connection to the HEARING AID are covered by the general standard.
NOTE 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.
This document 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; IEC 60645-1 applies;
- 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.
This document does not address applicable testing for intentional RF radiation of wireless equipment (e.g. maximum radiated output power, modulation bandwidth, etc.).