母亲胎儿监护仪相关专用标准的研究

Research on particular standards related to maternal fetal monitor

安全和性能可靠的母亲胎儿监护仪(简称母胎监护仪)可为孕产妇和胎儿提供全方面的生理监护,有效降低母婴死亡率。现阶段我国除母胎监护仪设备适用医用电气设备通用标准要求外,并无针对母胎监护仪的专用标准,行业普遍做法是参照和借鉴多参数监护仪和超声多普勒胎儿监护仪的专用标准。基于此,研究母胎监护仪适用的专用标准,针对母胎监护仪基本安全和基本性能要求,提出制定专用标准的设想,以期有效保障产品的安全有效性。

The safe and reliable maternal fetal monitor can provide comprehensive physiological monitoring for pregnant women and fetuses,and effectively reduce maternal and infant mortality.In the current stage,in addition to the general requirements of medical electrical equipment applicable to maternal fetal monitor in China,there is no particular standard for maternal fetal monitor.The common practice in the industry is to refer to and learn from the particular standards of multi-parameter monitor and ultrasonic Doppler fetal monitor.Based on this,the particular standards applicable to the maternal fetal monitor were researched,and the idea of formulating particular standards for the basic safety and essential performance requirements of the maternal fetal monitor were proposed to ensure the safety and effectiveness of the monitor.