Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

Designation Number:
CAN/CSA-C22.2 NO. 60601-2-66:15
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Reaffirmation
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

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.

 

Project need:

To review the Standard within the required 5 year period

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.