YY/T 0448-2019Ultrasonic Doppler fetal heartbeat detector (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY 0448-2009 "ultrasound Doppler fetal heart rate meter".

The main changes in this standard compared with YY 0448-2009 are as follows.

--- Removed two reference standards "GB/T 16846-2008" and "YY/T 1142-2003" (see Chapter 2 of the 2009 edition);

--- Added the definition of "ultrasonic Doppler fetal heart rate monitor" (see 3.1);

--- Removed duplicate definitions from YY/T 0749-2009 (see 3.2, 3.3, 3.5 and 3.8 of the 2009 edition);

--- Added "fetal heart rate measurement and display range" and "fetal heart rate measurement error" (see 4.3 and 4.4);

--- Removed "space peak time peak sound pressure" "output ultrasonic power" and "effective area of ultrasonic transducer sensitive components" (see 4.3, 4.4 and 4.5) of the 2009 edition;

--- Removed "power supply voltage adaptability" and "continuous working time" (see 4.7 and 4.8 in 2009);

---Modified the test method of "sound operating frequency" (see 5.1, 5.1 of 2009 edition);

--- Added test methods for "fetal heart rate measurement and display range" and "fetal heart rate measurement error" (see 5.3 and 5.4);

--- Removed the "output power" "space peak time peak sound pressure" and "effective area of ultrasonic transducer sensitive components" test method (See 5.2, 5.3 and 5.4 of the 2009 edition);

--- Removed the test method of "power supply voltage adaptability" and "continuous working time" (see 5.7 and 5.8 of 2009 edition);

--- Removed the "inspection rules" (see Chapter 6 of the 2009 edition).

It is noted that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.

1 Scope

This standard specifies the terms and definitions, requirements and tests of ultrasound Doppler fetal heart rate monitor (also known as "fetal heart sound instrument" "fetal stethoscope"). method.

This standard is applicable to ultrasound Doppler fetal heart rate monitor for obtaining fetal heart motion information from pregnant women's abdomen according to the principle of ultrasound Doppler. (hereinafter referred to as "instrument").

This standard does not apply to continuous fetal heart rate monitoring devices that are attached to the abdomen of pregnant women using a multi-flat ultrasound Doppler transducer.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety

GB 9706.9 Medical electrical equipment - Part 2-37. Particular requirements for safety of ultrasonic diagnostic and monitoring equipment

GB/T 14710 Medical electrical requirements and test methods

YY/T 0749-2009 Ultrasound hand-held probe Doppler fetal heart rate tester performance requirements and measurement and reporting methods

3 Terms and definitions

The following terms and definitions as defined in YY/T 0749-2009 apply to this document.