YY/T 0704-2008Ultrasonics - Pulsed Doppler diagnostic system-Test procedures to determine performance (English PDF)
超声脉冲多普勒诊断系统性能试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 17, 2008
Implementation date
January 1, 2010
Scope
YY/T 0704-2008 is the English-translated version of 超声脉冲多普勒诊断系统性能试验方法.
YY/T 0704-2008 is the Chinese pharmaceutical industry standard, identical to IEC 61895:1999, that lays down test procedures for the performance of pulsed Doppler diagnostic ultrasound systems and describes the Doppler test objects used in those tests.
It deals with range-gated instruments that measure the Doppler shift from a sample volume at a chosen depth, defining quantities such as the -6 dB and -20 dB bandwidths and the centre frequency.
The tests apply to a complete system that is not split into subsystems, whether it stands alone or forms part of another ultrasound machine. Electrical safety, acoustic safety and electromagnetic compatibility are not covered.
The tests range from routine quality control by clinical staff to targeted fault checks and full manufacturer verification against specifications. Issued on 17 October 2008, it has applied since 1 January 2010.
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Document preview — YY/T 0704-2008
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C 41
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
Foreword
This standard and IEC 61895:1999 "ultrasonic pulse Doppler diagnostic system performance test method" is identical with the degree of coincidence.
The main difference between this standard and IEC 61895 as follows.
--- The original text of the "technical specifications" to "this standard";
--- IEC 61102:1991 "0.5 to 15MHz using hydrophones in the frequency range of the ultrasonic field measurements and descriptions" are equivalent turn Into GB/T 16540-1996 "acoustic characterization of ultrasonic fields in the frequency range 0.5 ~ 15MHz and measuring hydrophone Is Law ", so the standard is a direct reference to national standards; IEC 61206:1993" continuous wave Doppler ultrasound system performance test side Law "has been translated into equivalent YY/T 0705-2008, IEC 61390:1996" real-time ultrasound pulse-echo system performance test The method "has been translated into equivalent YY/T 0703-2008, so the standard is a direct reference to the above two industry standards.
--- Made a few changes in the edit format according to our standards. Appendix A of this standard is the data appendix.
Introduction
Usually associated with real-time B-mode and color flow imager combines pulsed Doppler flow meter and flow meter has been widely used in clinical Bed practice, the ultrasound transducer is the device periodically transmitting ultrasonic pulses measured by ultrasound and sports organizations reflection and scattering of Dhoop Doppler shift, Doppler shift is proportional to the velocity component along the reflector or scatterer ultrasonic beam direction. Probe after launching a set of ultrasound pulses, And as the receiver receives the reflected echoes, but does not receive all of the echo signal, but after a specified time delay, began to receive a A distance on the echo signal, and derive the Doppler shift (referred to as range gating), referred to as the instrument only beam area of the sampling area Movement within the sensitive, which can be used to determine the tissue velocity along the ultrasound beam with depth-dependent, transmitted to the extension of the distance between the gate by changing, You can adjust the position of the ultrasound beam along different depths of the sampling area, multi-channel devices can detect multiple simultaneous localization of the sampling area.
When the ultrasonic waves are scattered red blood cells, commonly used pulse Ultrasonic equipment blood flow.
This standard describes a set of test methods can be used to measure the performance of the system and the required test items, test methods and some related Test piece has been in the YY/T 0705 (IEC 61206) are discussed, and thus worthy of the standard reference in many ways, while others test And the test piece discusses see reference [1] and [2]. Test methods can be divided into the following three categories. The first category can enter outpatient doctor or technician Routine quality control test line, to ensure the system work under normal conditions, or with sufficient sensitivity; second category is not often used, But more targeted test methods, for example using the method when the suspect system operation failure; the third category is represented as to ensure compliance with specifications Demand by the manufacturer of the complete system tests carried out. Doppler ultrasonic pulse diagnosis System performance test method
1 Scope
This standard specifies.
--- Test Method for Measuring the pulse Doppler ultrasound system performance;
--- Doppler test pieces for these tests.
This standard applies to.
--- Pulsed Doppler ultrasound machine test system, the system is not broken down into subsystems or disconnect the connection between each other;
--- Test pulsed Doppler ultrasound system, the system may be a stand-alone or as part of other ultrasound machines.
This standard does not involve electrical safety, security and acoustic electromagnetic compatibility (EMC) content.
In general, the amount of work involved to carry out all the tests is unbearable, it is expected to be used as part of the regular choice.
However, we should gather experience to provide guidance for the selection, and the subject of ongoing work.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 16540-1996 acoustic characterization of ultrasonic fields in the frequency range 0.5 ~ 15MHz and measuring hydrophone law (eqv IEC 61102:1991)
YY/T 0703-2008 ultrasonic pulse echo the real-time system performance test method (IEC 61390:1996, IDT)
YY/T 0705-2008 Test Method for CW Doppler ultrasound systems (IEC 61206:1993, IDT)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1 -6 dB bandwidth
6dB lower than the spectral power at the maximum power spectral width between the two frequencies.
3.2 -20 dB bandwidth
20dB lower than the spectral power at the maximum power spectral width between the two frequencies.
3.3 Centre frequency
Zero-emission spectrum of the pulse of sound frequency. [GB/T 16540-1996 of 3.4, Change]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 16540-1996Acoustics. Measurement and characterisation of ultrasonic fields in the frequency range 0.5MHz to 15MHz. Hydrophone method
- YY/T 0703-2008Ultrasonics - Real-time pulse-echo systems - Test procedures to determine performance specifications
- YY/T 0705-2008Ultrasonics - Continuous-wave Doppler systems - Test procedures
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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
YY/T 0703-2008 — Ultrasonics - Real-time pulse-echo systems - Test procedures to determine performance specifications
YY/T 0705-2008 — Ultrasonics - Continuous-wave Doppler systems - Test procedures
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YY/T 0704-2008
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