YY/T 1480-2016 English PDF

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YY/T 1480-2016: Test methods of performance for ultrasonic elasticity imaging equipment based on acoustic radiation force
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1480-2016	139	Add to Cart	3 days	Test methods of performance for ultrasonic elasticity imaging equipment based on acoustic radiation force	Valid

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Basic data

Standard ID: YY/T 1480-2016 (YY/T1480-2016)
Description (Translated English): Test methods of performance for ultrasonic elasticity imaging equipment based on acoustic radiation force
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C41
Word Count Estimation: 7,756
Date of Issue: 2016-07-29
Date of Implementation: 2017-06-01
Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies): State Food and Drug Administration

YY/T 1480-2016: Test methods of performance for ultrasonic elasticity imaging equipment based on acoustic radiation force

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Test methods of performance for ultrasonic elasticity imaging equipment based on acoustic radiation force ICS 11.040.50 C41 People's Republic of China Pharmaceutical Industry Standard Performance of Ultrasonic Elastic Imaging Equipment Based on Acoustic Radiation experiment method 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Standardization Technical Committee of medical ultrasound equipment standardization sub-technical committee (SAC/TC10/SC2) Go back. The standard drafting unit. the key technology of medical ultrasound national joint engineering laboratory, the State Food and Drug Administration Hubei Medical Equipment Quality Supervision and Inspection Center. The main drafters of this standard. Chen Siping, Chen Xin, Jiang Yilin, Xuanyuan Kai. Performance of Ultrasonic Elastic Imaging Equipment Based on Acoustic Radiation experiment method

1 Scope

This standard specifies the term, definition, and definition of the performance of ultrasonic elastic imaging equipment based on acoustic radiation using ultrasonic elastic imitation of tissue molds, Test equipment and test methods. This standard applies to the use of ultrasonic echo imaging principle of human tissue elastic imaging equipment, the device of the type of force is the use of ultrasound The resulting focusing radiation force, the measured elasticity parameter, can be either a displacement or a shear wave velocity (or a shear wave velocity converted by the formula Modulus), the display can be measured or imaging. A reference classification of the Ultimate Elastic Imaging System is given in Appendix A, and the scope of application of this standard is the acoustic radiation pulse imaging in the appendix, Point shear wave elastic imaging, shear wave elasticity imaging

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. B - type Ultrasonic Diagnostic Equipment GB 10152-2009 Technical Requirements for Ultrasonic Imitation Body Molds YY/T 0937-2014

3 terms and definitions

GB 10152-2009 Definitions and the following terms and definitions apply to this document. 3.1 Ultrasonic elastic imaging equipment based on acoustic radiation force ultrasonicelasticityimagingequipmentbasedonacousticradi- ationforce The tissue is excited by an acoustic radiation force pulse focused at a given depth to produce a shear wave propagating along the axial direction perpendicular to the ultrasonic beam Tissue displacement or shear wave velocity information and display the device. Note. The device can contain measurement functions or imaging functions, the measurement function can show the region of interest in the shear wave velocity of the average, the imaging function can The tissue displacement or the shear wave velocity is superimposed on the ultrasonic pulse echo image in the form of an image by spatial position. 3.2 Ultrasonic elastic imitation of the body of the body model sonoelasticitytissue-mimickingphantom Ultrasonic elastic imitation of the material in different ways, for the detection of ultrasonic elastic image diagnostic equipment, passive performance. 3.3 Maximum depth of exploration maximumdepthofelasticimaging In the elastic imaging mode, the device can perform the elastic parameter measurement or the maximum depth of imaging in the ultrasonic elastic imitation body mold. Unit. cm (cm). 3.4 Shear wave velocity shearwavespeed) The propagation velocity of the shear wave (shear wave) in the medium. ......

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