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YY/T 1279-2015Test method for performance of three-dimensional ultrasonography (English PDF)

三维超声成像性能试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 2, 2015

Implementation date

January 1, 2016

Scope

YY/T 1279-2015 is the English-translated version of 三维超声成像性能试验方法.

YY/T 1279-2015 is the Chinese pharmaceutical industry standard that gives the terms, the definitions, the test device and the method for measuring the performance of three-dimensional ultrasonography with a phantom.

It applies to ultrasound imaging equipment that displays the probed object in three dimensions on its screen, over the transducer frequency range it states, and it covers the accuracy of the distances and volumes measured in the reconstructed image, the resolution and the depth of penetration. Issued on 2 March 2015, it has applied since 1 January 2016.

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Document preview — YY/T 1279-2015

National Standard of the People's Republic of China

ICS
11.040.50
Classification
C 41

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

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

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

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

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).

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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