标准摘要
[中文适用范围]： 本部分IEC 60601标准适用于肌电图仪和诱发电位设备的基本安全和基本性能。注1：基于肌电捕捉肌肉收缩的肌反馈设备在本文件范围内。注2：肌电图仪和诱发电位设备用于诊断和监测应用。注3：如果设备同时支持肌电图和诱发电位刺激，则电、听觉和视觉刺激器的条款适用。如果设备仅支持肌电图而不支持诱发电位刺激，则仅关于刺激器要求的条款不在本文件范围内。 [外文原描述]： IEC 60601-2-40:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT. The following ME EQUIPMENT are excluded: - ME EQUIPMENT intended for therapeutic application; - ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10). IEC 60601-2-40:2024 cancels and replaces the second edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) added requirements for constant voltage stimulators; b) clarified requirements for VISUAL STIMULATORS.
英文名称Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment