IEC 60601-2-40:2024 医用电气设备第2-40部分:肌电图和诱发反应设备的基本安全和基本性能的特殊要求

标准编号：IEC 60601-2-40:2024

中文名称：医用电气设备第2-40部分:肌电图和诱发反应设备的基本安全和基本性能的特殊要求

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

发布日期：2024-12-20

标准范围

IEC 60601-2-40:2024适用于肌电图仪和诱发反应设备（以下简称ME设备）的基本安全性和基本性能。不包括以下ME设备:-用于治疗应用的ME设备；-用于经皮神经电刺激器和肌肉电刺激器的ME设备（IEC 60601-2-10涵盖的ME设备）。IEC 60601-2-40:2024取消并取代2016年发布的第二版。本版构成技术修订版。与上一版相比，此版本包括以下重大技术变更:a)增加了恒压刺激器的要求；b)明确了对视觉刺激器的要求。

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.

标准预览图