关于无创监护仪标准的解读

Interpretation of Standards for Noninvasive Monitors

无创监护仪是一种集机械、光学、电子、计算机软硬件为一体的生命支持类医疗设备,广泛应用于各地各级医院中,分布在手术室,重症监护室(ICU),冠心病房(CCU)、急诊室、产科等。监护仪对病人多种生理参数进行实时采集、存储、分析显示并传送给医护人员,以供医护人员对患者的当前状态进行分析并作出正确的判断及处理。病人监护仪设备在上市之前,需要进行严格的注册检验,符合国家标准和行业标准,从而确保产品的安全、有效和质量可控。本文对无创监护仪设备所适用的标准等进行了梳理和解读。

Non-invasive monitor is a kind of life support medical equipment integrating mechanical,optical,electronic,computer hardware and software.It is widely used in all levels of hospitals,distributed in the operating room,intensive care unit,coronary ward(CCU),emergency room,obstetrics and so on.The monitor can collect,store,analyze and display various physiological parameters of the patient in real time and transmit them to the medical staff,so that the medical staff can analyze the current state of the patient and make a correct judgment and treatment.Patient monitor equipment before the market,need to undergo strict registration inspection,in line with national standards and industry standards,so as to ensure the safety,effectiveness and controllable quality of the product.In this paper,the applicable standards of non-invasive monitor equipment are sorted out and interpreted.