大尺寸医疗器械传导抗扰度测量不确定度评定

Evaluation of Uncertainty in Measurement of Conducted Immunity of Large-sized Medical Devices

我国医疗器械行业快速发展,大尺寸医疗器械产品也越来越多。由于大尺寸医疗器械测试布置的独特性,测试布置和测试方法的差异都会在试验结果中引入大量的不确定度。为了提高大尺寸医疗器械传导抗扰度-CDN注入法测量结果的一致性,文章根据电磁兼容标准GB/T 17626.6-2017中规定的要求和方法,分析了影响其测量不确定度的各种因素,建立了不确定度评定的数学模型,经分析和计算后,得到大尺寸医疗设备的不确定度评定的结果,确定了测量结果的可信度。

China’s medical device industry is developing rapidly, and there are more and more large-sized medical device products. Due to the uniqueness of large-sized medical device test arrangements, differences in test arrangements and test methods will introduce a large amount of uncertainty into the test results. To improve the consistency of the measurement results of the large-scale medical device conducted immunity-CDN injection method. According to the requirements and methods specified in the electromagnetic compatibility standard GB/T 17626.6-2017, the article analyzes various factors affecting its measurement uncertainty. A mathematical model for uncertainty evaluation was established. After analysis and calculation, the uncertainty evaluation results of large-sized medical devices were obtained, and the credibility of the measurement results was determined.