YY/T 1480-2016Test methods of performance for ultrasonic elasticity imaging equipment based on acoustic radiation force (English PDF)
基于声辐射力的超声弹性成像设备性能试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1480-2016 is the English-translated version of 基于声辐射力的超声弹性成像设备性能试验方法.
YY/T 1480-2016 is the Chinese pharmaceutical industry standard that gives the terms and definitions, the test equipment and the test methods for the performance of ultrasonic elasticity imaging equipment based on acoustic radiation force, using tissue-mimicking elastic phantoms.
It sets out the phantom and its inclusions, the acquisition of the elasticity images or of the shear wave speed, and the measurements of accuracy, contrast, resolution and depth of penetration by which the system is characterised. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1480-2016
National Standard of the People's Republic of China
- Classification
- C 41
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions GB 10152-2009 Definitions and the following
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the term, definition, and definition of the performance of ultrasonic elastic imaging equipment based on acoustic radiation using ultrasonic elastic imitation of tissue molds, Test equipment and test methods.
This standard applies to the use of ultrasonic echo imaging principle of human tissue elastic imaging equipment, the device of the type of force is the use of ultrasound The resulting focusing radiation force, the measured elasticity parameter, can be either a displacement or a shear wave velocity (or a shear wave velocity converted by the formula Modulus), the display can be measured or imaging.
A reference classification of the Ultimate Elastic Imaging System is given in Appendix A, and the scope of application of this standard is the acoustic radiation pulse imaging in the appendix, Point shear wave elastic imaging, shear wave elasticity imaging
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
B - type Ultrasonic Diagnostic Equipment GB 10152-2009 Technical Requirements for Ultrasonic Imitation Body Molds YY/T 0937-2014
3 Terms and definitions
GB 10152-2009 Definitions and the following terms and definitions apply to this document.
3.1 Ultrasonic elastic imaging equipment based on acoustic radiation force
ationforce The tissue is excited by an acoustic radiation force pulse focused at a given depth to produce a shear wave propagating along the axial direction perpendicular to the ultrasonic beam Tissue displacement or shear wave velocity information and display the device.
Note: The device can contain measurement functions or imaging functions, the measurement function can show the region of interest in the shear wave velocity of the average, the imaging function can The tissue displacement or the shear wave velocity is superimposed on the ultrasonic pulse echo image in the form of an image by spatial position.
3.2 Ultrasonic elastic tissue-mimicking phantom
Ultrasonic elastic imitation of the material in different ways, for the detection of ultrasonic elastic image diagnostic equipment, passive performance.
3.3 Maximum depth of exploration
In the elastic imaging mode, the device can perform the elastic parameter measurement or the maximum depth of imaging in the ultrasonic elastic imitation body mold. Unit. cm (cm).
3.4 Shear wave velocity
shearwavespeed) The propagation velocity of the shear wave (shear wave) in the medium.
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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.
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