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YY/T 0704-2008: Ultrasonics. Pulsed Doppler diagnostic system. Test procedures to determine performance
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Ultrasonics. Pulsed Doppler diagnostic system. Test procedures to determine performance
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YY/T 0704-2008
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Basic data | Standard ID | YY/T 0704-2008 (YY/T0704-2008) | | Description (Translated English) | Ultrasonics. Pulsed Doppler diagnostic system. Test procedures to determine performance | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 22,218 | | Date of Issue | 2008-10-17 | | Date of Implementation | 2010-01-01 | | Quoted Standard | GB/T 16540-1996; YY/T 0703-2008; YY/T 0705-2008 | | Adopted Standard | IEC 61895-1999, IDT | | Regulation (derived from) | SFDA [2008] No. 605 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: Measuring Pulsed Doppler ultrasound system performance test methods, used for these tests Doppler test piece. This standard applies to: pulsed Doppler ultrasound system for machine testing, the system is not broken down into subsystems, or disconnect the connection between each other, on pulsed Doppler ultrasound system testing, the system can be independent, or as part of another ultrasonic instrument. This standard does not involve electrical safety, acoustic safety and electromagnetic compatibility (EMC) of the content. | YY/T 0704-2008: Ultrasonics. Pulsed Doppler diagnostic system. Test procedures to determine performance
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Ultrasonics.Pulsed Doppler diagnostic system.Test procedures to determine performance
ICS 11.040.50
C41
People's Republic of China pharmaceutical industry standards
YY/T 0704-2008/IEC 61895.1999
Doppler ultrasonic pulse diagnosis
System performance test method
(IEC 61895.1999, IDT)
Posted 2008-10-17
2010-01-01 implementation
State Food and Drug Administration issued
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.
This standard was proposed by the State Food and Drug Administration.
This standard by the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee Technical Committee (SAC/TC10/SC2)
Centralized.
This standard was drafted. medical ultrasound equipment Wuhan National Quality Supervision and Inspection Center.
The main drafters of this standard. Ashmore busy, Wang Zhijian, Jiang Shilin.
YY/T 0704-2008/IEC 61895.1999
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.
YY/T 0704-2008/IEC 61895.1999
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
6dB lower than the spectral power at the maximum power spectral width between the two frequencies.
3.2
20dB lower than the spectral power at the maximum power spectral width between the two frequencies.
3.3
Center frequency centrefrequency
Zero-emission spectrum of the pulse of sound frequency.
[GB/T 16540-1996 of 3.4, Change]
YY/T 0704-2008/IEC 61895.1999
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