标准摘要
[中文适用范围]： 本标准规定了用于物理医学实践的神经和肌肉刺激器（定义为201.3.204）的安全要求，以下称为ME设备。这包括经皮神经电刺激器（TENS）和电肌肉刺激器（EMS）。 注：肌肉刺激器也可能被称为神经肌肉刺激器。 以下ME设备被排除： - 旨在植入或连接至植入电极的ME设备； - 旨在用于脑刺激（例如电休克疗法ME设备）的设备； - 旨在用于神经学研究的设备； - 体外心脏起搏器（见IEC 60601-2-31）； - 旨在用于平均诱发电位诊断的设备（见IEC 60601-2-40）； - 旨在用于肌电图的设备（见IEC 60601-2-40）； - 旨在用于心脏除颤的设备（见IEC 60601-2-4）。 [外文原描述]： IEC 60601-2-10:2012+A1:2016 specifies the requirements for the safety and essential performance of nerve and muscle stimulators, for use in the practice of physical medicine. This includes transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS). This second edition cancels and replaces the first edition, published in 1987 and its Amendment 1 (2001). This edition constitutes a technical revision and is aligned with IEC 60601-1:2005+A1:2012. This consolidated version consists of the second edition (2012) and its amendment 1 (2016). Therefore, no need to order amendment in addition to this publication.
英文名称Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and musclestimulators