UNE-EN IEC 60601-2-66:2020

Clause 1 of the general standard1 applies, except as follows:

201.1.1 * Scope

Replacement:

This International Standard 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 sub-clause is specifically intended to be applicable to HEARING AIDS only, or to HEARING AID SYSTEMS only, the title and content of that clause or sub-clause will say so. If that is not the case, the clause or sub-clause 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 standard are not covered by specific requirements in this standard except in 201.7.9.2 and 201.9.6.

NOTE See also 201.4.2. (RISK MANAGEMENT).

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 a.c. 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 standard does not apply to:

cochlear implants or other implanted HEARING AIDS;

bone conduction HEARING AIDS;

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1 The general standard is IEC 60601-1:2005+A1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance.



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 standard does not address applicable testing for intentional RF radiation of wireless equipment (e.g.; maximum radiated output power, modulation bandwidth, etc.).

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY requirements for HEARING AIDS and HEARING AID SYSTEMS as defined in 201.3.202 and 201.3.203.