Appareils électromédicaux - Partie 2-66: Exigences particulières pour la sécurité de base et les performances essentielles des instruments d'audition et systèmes d'audition

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 INSTRUMENTS and HEARING INSTRUMENT SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.

 

If a clause or subclause is specifically intended to be applicable to HEARING INSTRUMENTS only, or to HEARING INSTRUMENT 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 INSTRUMENTS and to HEARING INSTRUMENT SYSTEMS, as relevant.

 

HAZARDS inherent in the intended physiological function of HEARING INSTRUMENTS or HEARING INSTRUMENT 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 INSTRUMENTS in the HOME HEALTHCARE ENVIRONMENT (e.g. remote control units, audio streamers, battery chargers, power supplies) are covered by the most applicable standard, IEC 60065, IEC 60950-1 or other applicable IEC safety standards. Alternatively the general standard may be applied. HEARING INSTRUMENTS do not have a MAINS PART intended for connection to a.c. SUPPLY MAINS. The connection to the SUPPLY MAINS of a HEARING INSTRUMENT system is covered by power supply, charger or other types of ACCESSORIES.

 

ACCESSORIES connected to a HEARING INSTRUMENT may form a HEARING INSTRUMENT SYSTEM. Only the HEARING INSTRUMENT and its detachable parts are subject to all applicable clauses of this particular standard. The remaining components of the HEARING INSTRUMENT SYSTEM are subject to requirements of this particular standard that result from their connection to the HEARING INSTRUMENT SYSTEM.

 

Programming interfaces or ACCESSORIES in a clinical application are covered by the general standard.

 

NOTE Detachable parts of HEARING INSTRUMENTS even if supplied separately (e.g. ear hooks, domes, wax guards etc.), are not regarded as ACCESSORIES.

 

This Standard does not apply to:

cochlear implants or other implanted HEARING INSTRUMENTS;

bone conduction HEARING INSTRUMENTS;

educational HEARING INSTRUMENTS (i.e. group HEARING INSTRUMENTS, auditory trainers etc.);

the application of a HEARING INSTRUMENT for the measurement of hearing levels. IEC 60645-1 applies;

audio-frequency induction-loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1;

assisted HEARING INSTRUMENT SYSTEMS using infra-red or radio;

the sound generating function of a tinnitus masker.

 

201.1.2 Object

 

Replacement:

 

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