1 Scope
This standard specifies the terms, definitions, test devices and test methods for testing the performance for ultrasonic elasticity imaging equipment based on acoustic radiation force by using sonoelasticity tissue-mimicking phantom.
This standard is applicable to the elasticity imaging equipment of human tissue based on the principle of ultrasonic echo imaging. The force application type of the equipment is the focused radiation force generated by ultrasound. The measured elastic parameters may be displacement or shear wave speed (or the elastic modulus converted from shear wave speed through equation), and the display mode may be measured value or imaging.
See Annex A for a reference classification of ultrasonic elasticity imaging system. The acoustic radiation force pulse imaging, point shear wave elasticity imaging and shear wave elasticity imaging (SWEI) in the annex are the scope of application of this standard.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 10152-2009 B mode ultrasonic diagnostic equipment
YY/T 0937-2014 Technical requirements for ultrasonically tissue-mimicking phantom
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 10152-2009, as well as the following, apply.
3.1
ultrasonic elasticity imaging equipment based on acoustic radiation force
equipment that excites the tissue with the acoustic radiation force pulse focused on the specified depth to generate the shear wave propagating along the axial direction perpendicular to the ultrasonic beam, and collects and displays the information of tissue displacement or shear wave speed
Note: The device includes measurement function or imaging function, in which the measurement function can display the average of shear wave speed in the region of interest, and the imaging function can overlay the tissue displacement or shear wave speed on the ultrasonic pulse-echo image in the form of image according to the spatial position.
3.2
sonoelasticity tissue-mimicking phantom
passive device composed of sonoelasticity tissue-mimicking materials in different ways, which is used to test the performance of ultrasonic elasticity imaging diagnosis equipment
3.3
maximum depth of elastic imaging
maximum depth of penetration which the equipment can measure the elastic parameters or image in the sonoelasticity tissue-mimicking phantom under the elasticity imaging mode
Unit: cm.
3.4
shear wave speed
propagation speed of shear wave (transverse wave) in medium
Unit: m/s.
3.5
spatial resolution
minimum target size that the equipment can clearly display the elastic image at a specific depth of the sonoelasticity tissue-mimicking phantom The size can be length, area, or volume.
Unit: mm; mm2; mm3.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Test conditions
5 Test methods
Annex A (Informative) Classification of ultrasonic elasticity imaging technology
1 Scope
This standard specifies the terms, definitions, test devices and test methods for testing the performance for ultrasonic elasticity imaging equipment based on acoustic radiation force by using sonoelasticity tissue-mimicking phantom.
This standard is applicable to the elasticity imaging equipment of human tissue based on the principle of ultrasonic echo imaging. The force application type of the equipment is the focused radiation force generated by ultrasound. The measured elastic parameters may be displacement or shear wave speed (or the elastic modulus converted from shear wave speed through equation), and the display mode may be measured value or imaging.
See Annex A for a reference classification of ultrasonic elasticity imaging system. The acoustic radiation force pulse imaging, point shear wave elasticity imaging and shear wave elasticity imaging (SWEI) in the annex are the scope of application of this standard.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 10152-2009 B mode ultrasonic diagnostic equipment
YY/T 0937-2014 Technical requirements for ultrasonically tissue-mimicking phantom
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 10152-2009, as well as the following, apply.
3.1
ultrasonic elasticity imaging equipment based on acoustic radiation force
equipment that excites the tissue with the acoustic radiation force pulse focused on the specified depth to generate the shear wave propagating along the axial direction perpendicular to the ultrasonic beam, and collects and displays the information of tissue displacement or shear wave speed
Note: The device includes measurement function or imaging function, in which the measurement function can display the average of shear wave speed in the region of interest, and the imaging function can overlay the tissue displacement or shear wave speed on the ultrasonic pulse-echo image in the form of image according to the spatial position.
3.2
sonoelasticity tissue-mimicking phantom
passive device composed of sonoelasticity tissue-mimicking materials in different ways, which is used to test the performance of ultrasonic elasticity imaging diagnosis equipment
3.3
maximum depth of elastic imaging
maximum depth of penetration which the equipment can measure the elastic parameters or image in the sonoelasticity tissue-mimicking phantom under the elasticity imaging mode
Unit: cm.
3.4
shear wave speed
propagation speed of shear wave (transverse wave) in medium
Unit: m/s.
3.5
spatial resolution
minimum target size that the equipment can clearly display the elastic image at a specific depth of the sonoelasticity tissue-mimicking phantom The size can be length, area, or volume.
Unit: mm; mm2; mm3.
Contents of YY/T 1480-2016
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Test conditions
5 Test methods
Annex A (Informative) Classification of ultrasonic elasticity imaging technology