YY/T 0749-2009Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting (English PDF)
超声 手持探头式多普勒胎儿心率检测仪 性能要求及测量和报告方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
November 25, 2009
Implementation date
December 1, 2010
Scope
YY/T 0749-2009 is the English-translated version of 超声 手持探头式多普勒胎儿心率检测仪 性能要求及测量和报告方法.
YY/T 0749-2009 is the Chinese medical device standard for hand-held probe Doppler foetal heartbeat detectors. It sets the methods for measuring the performance of a complete detector, the performance requirements, the way the performance of existing instruments is reported, and what the manufacturer publishes in the accompanying documents.
It covers detectors whose hand-held probe produces a single ultrasonic beam, applied to the abdomen of a pregnant woman and using continuous wave or quasi-continuous wave Doppler to obtain foetal heart motion information.
It does not cover multi-beam devices for continuous monitoring, which use a flat probe attached to the patient, and it is not a design standard. Identical to IEC 61266-1994, it cites GB 9706.1-2007, GB/T 16540-1996, GB/T 16846-2008, YY/T 0643-2008, IEC 60866-1987, IEC 61101-1991 and IEC 61161-1992. Issued on 25 November 2009, it has applied since 1 December 2010.
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Document preview — YY/T 0749-2009
National Standard of the People's Republic of China
- ICS
- 11.140.50
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY/T 0749-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB 9706.1-2007
GB/T 16540-1996
GB/T 16846-2008
YY/T 0643-2008
IEC 60866-1987
IEC 61101-1991
IEC 61161-1992
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 16540-1996Acoustics. Measurement and characterisation of ultrasonic fields in the frequency range 0.5MHz to 15MHz. Hydrophone method
- GB/T 16846-2008Requirement for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
- YY/T 0643-2008Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment
IEC 60866-1987 · IEC 61101-1991 · IEC 61161-1992
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Related Standards
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 the acoustic output of medical diagnostic ultrasonic equipment
YY/T 0643-2008 — Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment
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YY/T 0749-2009
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