YY/T 1521-2017Technical requirements for sonoelasticity tissue-mimicking phantom (English PDF)
超声弹性仿组织体模的技术要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 28, 2017
Implementation date
April 1, 2018
Scope
YY/T 1521-2017 is the English-translated version of 超声弹性仿组织体模的技术要求.
YY/T 1521-2017 is the Chinese pharmaceutical industry standard for the sonoelasticity tissue-mimicking phantom, the test object of elastic tissue-like materials against which an ultrasound elastography system is checked.
It sets the technical requirements for the phantom and the methods by which its performance parameters are measured, covering the elastic moduli of the materials and their contrast, the acoustic properties, the inclusions and their positions and the stability of the phantom over time.
It applies to phantoms used alone or together with pulse-echo diagnostic equipment. Issued on 28 March 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1521-2017
National Standard of the People's Republic of China
- ICS
- 11.040.55; 11.040.50
- Classification
- C 41
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the ultrasonic elastic imitation tissue phantom technical requirements and performance parameters of the measurement method.
This standard applies to ultrasonic elastic imitation tissue materials in different ways composed of phantom, the device is mainly used for independent or attached to the super Performance Testing of Ultrasound Elastic Image Forming System of Acoustic Pulse Echo Diagnostic Equipment.
Note. For the classification of ultrasound elastography, see Appendix A.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
Ultrasonic diagnostic equipment of type B GB 10152-2009 Methods of measurement of acoustic properties of supersonic imitation tissue materials
YY/T 0937-2014 Ultrasound imitation tissue phantom technical requirements Performance test method for elastic quasi - static strain elastic imaging equipment
3 Terms and definitions
As defined in GB 10152-2009, GB/T 15261-2008, YY/T 0937-2014 and YY/T 1419-2016 and under Terms and definitions apply to this document.
3.1 Ultrasound elastic imitation tissue model
Ultrasonic elastic imitation tissue materials in different ways, for the detection of ultrasound elastic image diagnostic equipment performance passive devices.
3.2 Ultrasound elastic imitation tissue material
In the MHz band, its longitudinal wave velocity, attenuation coefficient and shear frequency of low frequency (eg below 1.5kHz), Young's modulus and other physical properties Like human soft tissue material.
3.3 Target
Has the specified acoustic, mechanical properties and shape, size, embedded in the background ultrasonic elastic imitation tissue materials for the detection of elastography Something like a target that diagnoses certain properties of the device.
3.4 Ultrasound elastography (sonography)
Through the relevant technical means to obtain the human body shear wave velocity, elastic modulus, strain, displacement and other physical parameters, and images or graphics Display of technical methods.
3.5 Quasi-static strain imaging
Exerting pressure on human tissue from the outside or using the pressure generated by respiration and heart beating to distort the site of interest,
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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.
Referenced standards
Normative references
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Related Standards
YY/T 0937-2014 — Technical requirements for ultrasonic tissue-mimicking phantoms
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