YY/T 1521-2017 (YY/T1521-2017, YYT 1521-2017, YYT1521-2017) & related versions
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Technical requirements for sonoelasticity tissue-mimicking phantom
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YY/T 1521-2017: PDF in English (YYT 1521-2017)
YY/T 1521-2017
Technical requirements for sonoelasticity tissue-mimicking phantom
ICS 11.040.55; 11.040.50
C41
People's Republic of China pharmaceutical industry standards
Ultrasonic elastic imitation tissue phantom technical requirements
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The release of this document
The agency does not assume responsibility for identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Standardization Technical Committee Medical Ultrasound Equipment Standardization Technical Committee (SAC/TC10/SC2)
Focused.
This standard drafting unit. Acoustics Institute of Chinese Academy of Sciences, the State Food and Drug Administration Hubei Medical Device Quality Supervision and Inspection
center.
The main drafters of this standard Niu Fengqi, Zhu Cheng Gang, Cheng Yang, Jiang Shilin.
Ultrasonic elastic imitation tissue phantom technical requirements
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 article
Pieces. 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 sonoelasticitytissue-mimickingphantom
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 sonoelasticitytissue-mimickingmaterial
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) sonoelastography
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,
......
| Standard ID | YY/T 1521-2017 (YY/T1521-2017) | | Description (Translated English) | Technical requirements for sonoelasticity tissue-mimicking phantom | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.55; 11.040.50 | | Word Count Estimation | 15,136 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Institute of Acoustics, Chinese Academy of Sciences, the State Food and Drug Administration Hubei Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Medical Standardization Technical Committee Medical Ultrasound Equipment Standardization Technical Committee (SAC/TC 10/SC 2) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
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