Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this standard shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration.
This standard is under the jurisdiction of Subcommittee on Ultrasonic Equipment of the National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10/SC 2).
Drafting organizations of this standard: Local Joint Laboratory for Engineering of National Key Technology of Medical Ultrasound, National Medical Products Administration—Hubei Quality Supervision and Inspection Center for Medical Devices.
Chief drafters of this standard: Chen Siping, Chen Xin, Jiang Shilin, Xuanyuan Kai.
Test methods of performance for ultrasonic elasticity imaging equipment based on acoustic radiation force
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.
3.6
geometric error
percentage error of the target size displayed by the elastic image relative to its nominal size
The calculation equation is:
(D – D0)/D0 × 100% (1)
where,
D0——the nominal size of the target;
D——the measured size.
Geometric errors can be the errors in length, area or volume.
Unit: dimensionless.
3.7
repeatability of measurements
consistency between successive measurements of the same quantity measured under the same measurement conditions. In this standard, the repeatability of measurements is expressed by the coefficient of variation s, and its calculation equation is:
(2)
where,
xi——the single measured value;
——the arithmetic average of each measured value;
n——the number of measurements. In this standard, n ≥ 5.
Unit: dimensionless.
4 Test conditions
4.1 General
This standard adopts sonoelasticity tissue-mimicking phantom to measure relevant indexes, and equipment manufacturers and/or testing institutions can also adopt other methods.
The technical requirements for sonoelasticity tissue-mimicking phantom shall be in accordance with YY/T 0937-2014. The specification and model of the sonoelasticity tissue-mimicking phantom, the shear wave speed of the target and background, the target structure, geometric shape and other technical parameters and errors used in the test shall be recorded. Other sonoelasticity tissue-mimicking phantom meeting the test requirements of this standard may also be used, if any.
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
