标准摘要
[中文适用范围]： 本部分 IEC 60601 适用于肌电图仪和诱发电位设备的基本安全和基本性能，以下称为 ME 设备。 注1：基于肌电图的肌肉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 ME 设备同时支持肌电图和诱发电位刺激，则适用于电、听觉和视觉刺激器的条款。如果设备仅支持肌电图而不支持诱发电位刺激，则仅涉及刺激器要求的条款不在本文件范围内。 如果某个条款或子条款专门适用于 ME 设备或 ME 系统，则该条款或子条款的标题和内容会说明。如果不是这种情况，则该条款或子条款适用于 ME 设备和 ME 系统（视情况而定）。 以下 ME 设备不包括在内： • 用于治疗应用的 ME 设备； • 用于经皮电神经刺激器和肌肉电刺激器的 ME 设备（由 IEC 60601-2-10 涵盖）。 [外文原描述]： IEC 60601-2-40:2024 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. 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