符合新标准的医疗设备泄漏电流测试技术研究

Research on testing technique of leakage current conforming to new standards for medical equipment

在研究IEC新发布的医疗设备电气安全标准的基础上,设计了符合IEC60601标准的泄漏电流测试系统。本系统由测试电源、模拟人体网络、光隔离放大电路、信号调理电路、单片机系统和计算机组成,测试精度为±(0.02 mA+1.6%),不仅符合IEC新标准,而且满足多种安规标准要求,测试精度高,操作性能好,满足快速、专业测试的需要,具有良好的应用前景。

Based on a study of requirements for a newly published IEC standard for medical equipment electric safety, we designed and implemented a leakage current testing system conforming to IEC60601 standard. The system, which has testing accuracy up to ±（0. 02 mA ＋ 1.6% ）, is composed of power source, human body network simulation circuits, optical isolation amplifier circuits, signal conditioning circuits, MCU systems, as well as computer software system. The result of this study not only conforms to the new IEC standard for medical equipment, but also is in line with some other related standard series such as UL and GB;it meets the requirements of multiple standards on electric safety for testing. The high testing accuracy and easy-to-use features make the system ready for quick and professional testing usage. It is believed to have a good prospect of application in field.