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YY 0449-2018Ultrasonic Doppler fetal monitor (English PDF)

超声多普勒胎儿监护仪

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

November 7, 2018

Implementation date

November 1, 2019

Scope

YY 0449-2018 is the English-translated version of 超声多普勒胎儿监护仪.

YY 0449-2018 is the Chinese standard "Ultrasonic Doppler fetal monitor". Its scope clause reads: This standard specifies the terms and definitions, requirements, test methods and inspection rules for ultrasound Doppler fetal monitors.

This standard applies to ultrasound Doppler fetal monitor (hereinafter referred to as "instrument"), which uses continuous wave or pulse wave ultrasound Doppler Principle, continuous monitoring of the fetus during the perinatal period, and timely provide alarm information when an abnormality occurs. Its clauses include terms and definitions; requirements.

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Document preview — YY 0449-2018

National Standard of the People's Republic of China

Replacing: YY 0449-2009

Issued by: National Medical Products Administration of the People's Republic of China

1 Scope
2 Normative references
3 Terms and definitions
4 requirements

1 Scope

This standard specifies the terms and definitions, requirements, test methods and inspection rules for ultrasound Doppler fetal monitors.

This standard applies to ultrasound Doppler fetal monitor (hereinafter referred to as "instrument"), which uses continuous wave or pulse wave ultrasound Doppler

Principle, continuous monitoring of the fetus during the perinatal period, and timely provide alarm information when an abnormality occurs.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.

Pieces. 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 medical ultrasound diagnostic and monitoring equipment

GB/T 14710 Medical electrical requirements and test methods

YY 0709 Medical electrical equipment - Part 1-8. Safety general requirements. Parallel standard. General requirements, medical electrical equipment and medical

Testing and guidance for alarm systems in electrical systems

YY/T 1142 Medical Ultrasound Equipment and Probe Frequency Characteristics Test Method

3 Terms and definitions

The following terms and definitions apply to this document.

3.1

A device that continuously monitors the fetus during the perinatal period and provides alarm information in the event of an abnormality. The host, the ultrasound probe, and the palace

Compressed pressure sensor and other sensors connected to it, using ultrasonic Doppler principle to detect fetal heart rate, with monitoring and storage

Fetal heart rate, contraction pressure, and other parameters.

4 requirements

4.1 Ultrasonic operating frequency

The deviation of the ultrasonic operating frequency fW from the nominal frequency should be no more than ±10%.

4.2 fetal heart rate measurement and display range

The measurement and display range of fetal heart rate should be no narrower than 65 times/min~210 times/min.

4.3 fetal heart rate measurement error

The error in fetal heart rate measurement should be no more than ± 2 times/min.

4.4 Alarm function

The fetal heart rate alarm should meet the requirements specified in YY 0709, and the alarm state delay should not exceed 30s.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Editions of YY 0449

Edition	Title	Revision	Status
YY 0449-2018	Ultrasonic Doppler fetal monitor	current edition	Current
YY 0449-2009	Ultrasonic Doppler fetal monitor	previous edition	Superseded

This page sells the current edition, YY 0449-2018. Earlier editions are listed for reference only.

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