Research on particular standards related to maternal fetal monitor / 中国医学装备

ABSTRACT

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.