YY/T 1279-2015 English PDF

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YY/T 1279-2015: Test method for performance of three-dimensional ultrasonography
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Basic data

Standard ID: YY/T 1279-2015 (YY/T1279-2015)
Description (Translated English): Test method for performance of three-dimensional ultrasonography
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C41
Classification of International Standard: 11.040.50
Word Count Estimation: 11,190
Date of Issue: 2015-03-02
Date of Implementation: 2016-01-01
Quoted Standard: GB 10152-2009
Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard specifies the measurement phantom three-dimensional ultrasound imaging equipment performance terms, definitions, test device and method. This Standard applies to display three-dimensional ultrasound imaging equipment can be probed object on the display screen, its ultrasonic transducer frequency range of 1.5 MHz ~ 15 MHz. Over the frequency range of three-dimensional ultrasound imaging equipment can also refer to the use of this standard provides. This Standard does not preclude the use of other methods to detect the performance of three-dimensional ultrasound imaging equipment. In this standard, three-dimensional ultrasound imaging does not involve the reorganization of the way.

YY/T 1279-2015: Test method for performance of three-dimensional ultrasonography

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Test method for performance of three-dimensional ultrasonography ICS 11.040.50 C41 People's Republic of China pharmaceutical industry standards Three-dimensional ultrasound imaging performance test method Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. This standard by the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee Technical Committee (SAC/TC10/SC2) Centralized. This standard was drafted. State Food and Drug Administration of Hubei Medical Device Quality Supervision and Inspection Center, Shantou Ultrasonic Instrument Research Limited. The main drafters of this standard. Jiang Shilin, Guo Feng environment, Wang Zhijian, Li Qiang, Regulus Kay.

Introduction

After several stages of type A, M, B type, color Doppler ultrasound, the 1970s began a three-dimensional ultrasound imaging techniques Surgery (three-dimensionalultrasono-graphy) study, since the imaging process is slow, complicated to use and other reasons, limiting its clinical usage of. Reconstruction of three-dimensional (3D) ultrasound imaging, ultrasound imaging is a development stage technology. In recent years, flying along with computer technology Speed development of three-dimensional ultrasound imaging has made great progress, has entered the stage of clinical applications. GB 10152-2009 only provides a three-dimensional image Volume calculation error, does not require technical indicators and measurement methods other three-dimensional ultrasound imaging. As there are a considerable part of the B ultra Sound diagnostic apparatus includes this function, and three-dimensional imaging technology parameter settings different from the two-dimensional imaging, it is necessary to set its performance characteristics Justice and testing issues separately established. This standard provides a test method for three-dimensional ultrasound imaging equipment performance, taking into account the ultrasound Differences focus on their professional development and a variety of imaging equipment technology, this standard does not specify the parameters specific technical indicators. Due to the diversity of three-dimensional imaging methods, the manufacturer can declare some indicators of this standard or method is not applicable, such as free arm measuring systems The amount of volume, volume measurement accuracy may not be guaranteed and the like. Three-dimensional ultrasound imaging performance test method

1 Scope

This standard specifies the measurement phantom three-dimensional ultrasound imaging equipment performance terms, definitions, test device and method. This standard applies to probe the object can be displayed three-dimensional ultrasound imaging device on the display screen, the ultrasonic transducer frequency range Of 1.5MHz ~ 15MHz. Over the frequency range of three-dimensional ultrasound imaging equipment may also refer to the use of this standard provides. This standard does not exclude the use of other methods to detect the performance of three-dimensional ultrasound imaging equipment. In this standard, three-dimensional ultrasound imaging does not involve the reorganization of the way.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 10152-2009 B-type ultrasonic diagnostic equipment

3 Terms and Definitions

GB 10152 and as defined in the following terms and definitions apply to this document. 3.1 Three-dimensional ultrasound imaging three-dimensionalultrasonography Expressing a spatial relationship of each imaging mode structure within the volumetric region scanned by the ultrasonic beams in three dimensions. Its tomographic data Display of surface presentation, like, three-dimensional presentation more like a planar form or format. Including static display and dynamic display. 3.2 Axial resolution axialresolution At a predetermined depth in phantom, along the axis of the ultrasonic beam can be displayed as the minimum distance between two targets between the two echo signals. [See GB 10152-2009, Definition 3.1] Note 1. In this standard, "display" refers to two Dimensional surface three-dimensional imaging, or three-dimensional image. Note 2. millimeters (mm). 3.3 Lateral resolution lateralresolution In phantom predetermined depth, perpendicular to the axis of the ultrasonic beam direction, it can display two lines of the target echo signal between two clear of The minimum spacing. Taking into account the three-dimensional image in a direction perpendicular to the axis of the ultrasonic beam can have two lateral resolution, and therefore should be measured two dimensional imaging A lateral direction perpendicular to each other on the resolution, namely lateral resolution scanning direction and the pitch direction lateral resolution. See Figure 1. [See GB 10152-2009, the definition 3.2] Note 1. The now common use of three-dimensional imaging scan three-dimensional mechanical probe, usually three-dimensional mechanical scanning probe electron scanning plane (wafer front) parallel resolution Force, known as the lateral resolution scanning direction, a direction perpendicular to the scanning resolution, the pitch direction is called lateral resolution. Note 2. millimeters (mm). ......

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