YY/T 1919-2023Test methods of performance for ultrasonic contrast imaging (English PDF)
超声造影成像性能试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 5, 2023
Implementation date
September 15, 2024
Scope
YY/T 1919-2023 is the English-translated version of 超声造影成像性能试验方法.
YY/T 1919-2023 is the Chinese standard "Test methods of performance for ultrasonic contrast imaging". Its scope clause reads: This document describes the test conditions and test methods for ultrasound contrast imaging imaging performance of ultrasound imaging equipment.
This document applies to ultrasound imaging equipment with contrast capabilities. This document does not apply to ultrasound imaging equipment that uses gastrointestinal visualization aids for signal enhancement. Its clauses include normative reference documents; terms and definitions.
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Document preview — YY/T 1919-2023
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C41
Issued by: National Medical Products Administration
Contents
- Preface
- 1 Scope
- 2 Normative reference documents
- 3 Terms and Definitions
- 4 Test conditions
- 5 Test method
- Appendix A (informative) Ultrasound contrast imaging technology
- Appendix B (informative) Example 6 of contrast-enhanced ultrasound imaging performance test and indicator publication
1 Scope
This document describes the test conditions and test methods for ultrasound contrast imaging imaging performance of ultrasound imaging equipment.
This document applies to ultrasound imaging equipment with contrast capabilities.
This document does not apply to ultrasound imaging equipment that uses gastrointestinal visualization aids for signal enhancement.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.
GB 10152 Type B ultrasonic diagnostic equipment
YY/T 0458 Technical requirements for ultrasonic Doppler blood imitation fluid model
3 Terms and definitions
The following terms and definitions as defined in GB 10152 apply to this document.
3.1
The shell contains inert gas, which is similar in size to red blood cells. It can pass through the pulmonary circulation but cannot penetrate the blood vessel wall. It can be injected through intravenous injection.
It is injected into the blood circulation system or directly injected into the body cavity after being diluted with physiological saline. It has strong backscattering and can improve the analysis of ultrasound imaging diagnosis.
Microbubble preparation with high resolution, sensitivity and specificity.
3.2
With the help of ultrasound contrast agent to enhance the backscattering intensity in blood vessels or body cavities, the enhanced ultrasound echo is collected in real time for contrast signal detection,
The function of imaging processing and display.
Note 1.This function can display the ultrasonic echo from the ultrasonic contrast agent and the ultrasonic echo from the tissue side by side or superposed in image form according to the spatial position.
Note 2.See Appendix A.
3.3
It consists of an ultrasonic tissue-imitation material and a pipeline embedded in it, and an ultrasonic contrast agent is added to the imitating blood fluid flowing in the pipeline.
A device for testing the performance of contrast-enhanced ultrasound imaging.
Note. The function of the ultrasound contrast imaging phantom can be achieved by adding a certain amount of ultrasound contrast agent to the ultrasound Doppler imitation blood fluid phantom.
3.4
In the contrast imaging mode, the device under inspection can clearly observe the maximum depth of the ultrasound contrast agent signal using the ultrasound contrast imaging phantom.
Note. The unit of the maximum depth of contrast imaging is millimeters (mm).
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 6 pages — is available in the English PDF.
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Related Standards
GB 10152-2009 — B mode ultrasonic diagnostic equipment
YY/T 0458-2003 — Technical requirements for ultrasonic blood-mimicking Doppler phantoms
YY/T 0458-2014 — Technical requirements for ultrasonically blood-mimicking Doppler phantom
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YY/T 1919-2023
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