摘要
本文以口腔颌面锥形束计算机体层摄影设备为例,基于YY 9706.102—2021《医用电气设备第1-2部分:基本安全和基本性能的通用要求并列标准:电磁兼容要求和试验》进行不同工作模式下的电磁兼容测试。新版电磁兼容标准侧重于对医用电气设备基本性能的考察,本文结合具体的电磁兼容试验案例,分析被测设备的不合格情况和整改措施,为更好理解和实施YY 9706.102—2021提供一些思路和启发。
This paper takes the oral and maxillofacial cone beam computer tomography equipment as an example to conduct electromagnetic compatibility testing based on YY 9706.102—2021 standard under different working modes.The new version of the electromagnetic compatibility standard focuses on the inspection of the basic performance of medical electrical equipment.By analyzing specific cases of electromagnetic compatibility testing,this paper examines the unqualified condition of the tested equipment and rectification measures,providing insights and inspiration for better understanding and implementation of YY 9706.102—2021 standard.
作者
刘鹏
孟昭阳
林蒙
LIU Peng;MENG Zhao-yang;LIN Meng(Liaoning Inspection,Examination&Certification Centre;Wuhan United Imaging Healthcare Surgical Technology Co.,Ltd.)
出处
《中国食品药品监管》
2023年第6期40-45,共6页
China Food & Drug Administration Magazine