新版9706系列标准下的多参数监护仪电磁兼容测试方法浅析

Analysis of Electromagnetic Compatibility Test Method of Multi-Parameter Monitor Under New 9706 Series Standard

近年来医疗器械新版9706系列专用标准由国家药品监督管理局陆续发布并实施,在行业内引起了巨大反响,为此从国家局到各个医疗器械检验检测机构都在紧密谋划部署新版系列9706标准的扩项问题。作为系列9706标准中最重要的两份标准GB 9706.1-2020和YY 9706.102-2021已经正式实施,经过这两年的努力,到目前为止基本上各个医疗器械检验检测机构都已经具备这两份新标准的检验检测能力。文章主要针对医疗器械中最常见的多参数监护仪(其也是涉及专用标准较多的一类医疗器械)的电磁兼容检验进行浅析。

In recent years,the new version of 9706 series of special standards for medical devices have been issued and implemented by the State Drug Administration,which has caused a huge response in the industry,so that from the National Bureau to various medical device inspection and testing institutions are closely planning to deploy the expansion of the new version of 9706 series of standards.As the two most important standards in the series of 9706 standards GB 9706.1-2020 and YY 9706.102-2021 have been officially implemented,after two years of efforts so far,basically all medical device inspection and testing institutions have had the ability to test these two new targets.This paper mainly analyzes the electromagnetic compatibility test of the most common multiparameter monitor in medical devices,and also involves a class of medical devices with more special standards.