医用电气设备.第2-66部分:听力仪器和听力仪表系统基本安全性和必要性能的详细要求

[中文适用范围]： 替代：本国际标准适用于听力仪器和听力仪器系统@的基本安全，以下也称为ME设备或ME系统。如果某个条款或子条款专门旨在仅适用于听力仪器@或仅适用于听力仪器系统@，则该条款或子条款的标题和内容将如此说明。如果情况并非如此@，则该条款或子条款适用于相关的听力仪器和听力仪器系统@。除 201.7.9.2 和 201.9.6 外，本标准中的具体要求不涵盖本标准范围内助听器或助听器系统的预期生理功能所固有的危害。注：另见 201.4.2。 （风险管理）。家庭保健环境中的助听器配件（例如遥控器@音频流媒体@电池充电器@电源）均受最适用的标准@ IEC 60065@ IEC 60950-1 或其他适用的IEC 安全标准管辖。或者，可以应用通用标准。听力仪器没有用于连接交流电源的电源部分。听力仪器系统的电源连接由电源@充电器或其他类型的配件覆盖。连接到听力仪器的配件可以形成听力仪器系统。只有听力仪器及其可拆卸部件受本特定标准所有适用条款的约束。听力仪器系统的其余组件因与听力仪器系统的连接而受到此特定标准的要求的约束。通用标准涵盖了临床应用中的编程接口或配件。注意 助听器的可拆卸部件，即使单独提供（例如耳钩@圆顶@耵聍罩等）@也不被视为配件。本标准不适用于： ?C 人工耳蜗或其他植入式助听器； ?C 骨传导助听器； ?C 教育助听器（即团体助听器@听觉训练器等）； ?C 应用听力仪器测量听力水平。 IEC 60645-1 适用； IEC 60118-4 和 IEC 62489-1 中描述的“C 音频感应环路系统或其组成部分”； ?C 使用红外线或无线电辅助听力仪器系统； ?C 耳鸣掩蔽器的发声功能。 [外文原描述]： IEC 60601-2-66:2012 International Standard applies to the basic safety of hearing instruments and hearing instrument systems. 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. 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. 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. 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; - and the sound generating function of a tinnitus masker.