CSA C22.2 NO. 60601-2-66:21

CSA Preface

This is the second edition of CSA C22.2 No. 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 , which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-66 (third edition, 2019-10). It supersedes the previous edition, published in 2015 as CAN/CSA-C22.2 No. 60601-2-66 (adopted IEC 60601-2-66:2012), Medical electrical equipment – Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems. It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations).

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

Scope and object

Clause 1 of the general standard1 applies, except as follows: 201.1.1 *

Scope Replacement: 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 201.7.9.2 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.). 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.