This standard specifies the terms and definitions, requirements, test methods, and inspection rules for ultrasonic Doppler fetal monitors. This standard applies to ultrasonic Doppler fetal monitors. This product uses the principle of continuous wave or pulse wave ultrasonic Doppler to continuously monitor the fetus during the perinatal period and provide alarm information when abnormalities occur.
YY 0449-2009 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB 9706.9-2008 Medical electrical equipment.Part2-37:Particular requirements for the safety of ultrasonic medical diagnosetic and monitoring equipment
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
GB/T 16846-2008 Requirement for the declaration of acoustic output of medical diagnostic ultrasonic equipment
YY/T 1142-2003 Methods of measuring the frequency of medical diagnostic and monitoring ultrasonic equipment