YY/T 0749-2009 (English Version) PDF

Scope: This standard specifies: Complete performance measurement methods for handheld ultrasonic Doppler fetal heart rate monitors; Performance requirements for the instrument; Performance reporting requirements for existing instruments; Requirements for the performance of the instrument published by the manufacturer in the accompanying documents. This standard applies to ultrasound Doppler fetal heart rate monitors that generate a single ultrasound beam and consist of a handheld probe, which are applied to the abdomen of pregnant women and obtain fetal heart movement information by using continuous wave or quasi-continuous wave ultrasound Doppler methods. This standard does not currently apply to continuous monitoring devices that generate multiple ultrasound beams, which typically operate on a similar principle but use a flat probe attached to the patient. This standard is not an instrument design standard.

YY/T 0749-2009 Referenced Document

GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 16540-1996 Acoustics--Measurement and characterisation of ultrasonic fields in the frequency range 0.5MHz to 15MHz--Hydrophone method
GB/T 16846-2008 Requirement for the declaration of acoustic output of medical diagnostic ultrasonic equipment
YY/T 0643-2008 Methods of measuring the performance of ultrasonic plus-echo diagnostic equipment

2009 YY/T 0749-2009 Ultrasonics.Hand-held probe Doppler foetal hearbeat detectors.Performance requirements and methods of measurement and reporting