手术无影灯电磁兼容测试常见不符合项及整改建议

Common Non-Conformance Items and Rectification Recommendations of Surgical Shadowless Lamp in Electromagnetic Compatibility(EMC) Test

手术无影灯作为二类医疗器械,在注册检验中须根据《医用电气设备第1-2部分:安全通用要求并列标准:电磁兼容要求和试验》标准通过电磁兼容(EMC)测试。目前手术无影灯在电磁兼容性方面的设计和整改还存在不少问题。本文对手术无影灯检测工作中遇到的常见不合格项目进行了总结,阐述了手术无影灯的电源、操作面板、驱动板、电源线等部分对于电磁兼容性可能造成的影响,并提出常用的整改措施及注意事项。

Surgical shadowless lamp as class II medical equipment must pass the electromagnetic compatibility(EMC) test in the registration test according to YY 0505-2012 Medical electrical equipment-Part1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility-Requirments and tests. At present, there are still many problems in the design and improvement of electromagnetic compatibility of surgical shadowless lamp. This paper summarizes the common non-conformance encountered in the daily test work, expounds the possible influence of power supply, operation panel, driving board, power line and other parts of surgical shadowless lamp on electromagnetic compatibility, and gives some common rectification measures and points for attention.