CSA序言这是CSA C22的第二版。2第60601-2-66号，医用电气设备-第2-66部分:助听器和助听器系统基本安全和基本性能的特殊要求，采用了相同名称的IEC（国际电工委员会）标准60601-2-66（第三版，2019-10），但存在加拿大偏差。它取代了2015年以CAN/CSA-C22发布的上一版本。2编号60601-2-66（采用IEC 60601-2-66:2012），医用电气设备-第2部分- 66:助听器和助听器系统的基本安全和基本性能的特殊要求。它是CSA集团根据《加拿大电气规范》第二部分发布的一系列标准之一。本标准拟与CAN/CSA-C22结合使用。2 No.60601-1:14，医用电气设备-第1部分:基本安全和基本性能的一般要求（采用IEC 60601-1:2005，包括修改件1:2012，带有加拿大偏差）。本标准的制定符合加拿大标准委员会对加拿大国家标准的要求。 CSA集团已将其作为加拿大国家标准发布。范围和目的通用标准1第1条适用，以下情况除外:201.1.1*范围替换:IEC 60601的本部分适用于助听器和助听器系统的基本安全，以下也称为医用电气设备或医用电气系统。如果某一条款或子条款明确规定仅适用于助听器，或仅适用于助听器系统，则该条款或子条款的标题和内容应如此说明。如果不是这样，本条款或子条款适用于助听器和助听器系统（视情况而定）。 除201.7.9.2和201.9.6外，本文件的具体要求未涵盖本文件范围内助听器或助听器系统预期生理功能的固有危害。注:另见通用标准的4.2。家庭医疗环境中助听器的附件（例如遥控器、音频拖缆、电池充电器、电源）可根据适用标准、IEC 60065、IEC 60950-1、IEC 62368-1或其他适用的IEC安全标准进行测试。或者，也可采用通用标准。 助听器没有用于连接交流电源的电源部件。助听器系统电源干线的连接由电源、充电器或其他类型的附件覆盖。与助听器有功能连接的附件可以构成助听器系统。正常使用期间未与助听器进行物理连接的助听器相关附件不被视为应用部件，因为它们不会直接影响助听器的预期用途。适用标准IEC 60065、IEC 60950涵盖了无线编程接口- IEC 62368-1或其他适用的IEC安全标准。或者，也可采用通用标准。通用标准涵盖了与助听器有线连接的编程接口。注:助听器的可拆卸部件，即使是单独提供的（例如耳钩、耳罩、蜡罩等），也不被视为附件，而是组成部件。本文件不适用于:-人工耳蜗或其他植入助听器；-骨传导助听器；-教育助听器（即集体助听器、听觉培训师等）。 ); - 使用助听器测量听力水平；IEC 60645-1适用；-按照IEC 60118-4和IEC 62489-1所述，安装音频感应回路系统或其部件耳鸣面罩的发声功能。本文件不涉及无线设备有意射频辐射的适用测试（例如最大辐射输出功率、调制带宽等）。201.1.2对象更换:本特定标准的目的是为201中定义的助听器和助听器系统制定特定的基本安全要求。 3.202和201.3.203。

CSA PrefaceThis 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 objectClause 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.