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YY/T 0643-2008Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment (English PDF)

超声脉冲回波诊断设备性能测试方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

April 25, 2008

Implementation date

June 1, 2009

Scope

YY/T 0643-2008 is the English-translated version of 超声脉冲回波诊断设备性能测试方法.

YY/T 0643-2008 is a Chinese medical device industry standard, identical to IEC/TR 60854:1986, that explains how to measure the performance of pulse-echo ultrasonic diagnostic equipment.

Its main body is organised in six clauses, each naming one system performance parameter or a group of related ones together with the method for measuring it, built on terms such as transducer element, standard working distance and beam axis; informative Annexes A to C collect the principles and the equipment shared by several methods.

It applies to diagnostic equipment with single-element transducers in the 0.5 MHz to 25 MHz range, excludes Doppler systems and leaves acoustic output measurement to other publications.

The aim is a common basis on which manufacturers of similar devices can be compared without expensive test equipment. Issued on 25 April 2008, it has applied since 1 June 2009.

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Document preview — YY/T 0643-2008

National Standard of the People's Republic of China

ICS
11.040.50; 17.140.50
Classification
C 41

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

Contents

  • Foreword
  • 1 Scope and purpose
  • 2 Terms and definitions

Foreword

This standard is equivalent to using IEC /T R60854. 1986 "pulse-echo ultrasound diagnostic device performance test methods) (in English).

The original text of this standard the "Technical Report" to the "standard", and made a very small number of editorial changes do not affect the degree of consistency.

This standard Annex A, Annex B, Annex C is informative appendices.

1 Scope and purpose

1.1 Scope

This standard defines the pulse-echo measurement described in medical diagnostic system performance parameters, and gives the test methods.

This standard applies to single-element transducer array of ultrasonic diagnostic equipment in the ultrasonic frequency range 0.5MHz ~ 25MHz. This standard does not apply to ultrasound systems.

1.2 Purpose

It provides general acceptable basis for the measurement and reporting of the entire diagnostic system main performance parameters, especially for similar diagnostic applications without Between manufacturers of similar devices to provide the same basis for comparison, select the specified performance parameters and the corresponding measurement method. Furthermore, the purpose of To obtain a set of measurements and results from the application of the recommended method provided useful basis for predicting the device performance in a particular diagnostic applications.

In order to be able to generally applicable, in a specified process without using expensive and common equipment. When the basic system has about a specific diagnosis system When the member (such as a transducer) a variety of optional, when applicable requirements of this standard will each option as a separate system.

The main part of the standard consists of six terms, namely to specify a specific system performance parameter (or a group of related articles in each Parameters) and give the appropriate measurement method.

The necessary data and measurement methods, principles and related equipment (applies to two or more terms) is given in the Appendix.

Measuring the acoustic output of diagnostic equipment have been proposed in other publications, and therefore not specified in this standard.

2 Terms and definitions

The following terms and definitions apply to this standard.

2.1 Transducer element

Made of a specific material capable of electrical energy into mechanical energy but also mechanical energy into electrical energy element.

2.2 Transducer

Design of the input signal at the output of the desired characteristics of the output signals received from the system and provide a signal to another device of the system. Head of Prior to the actual applications, the transducer this term represents the complete mechanical assemblies, including the transducer element and the damping of mechanical and electronic And matching means.

2.3 Standard working distance

The transducer in the water, from the surface of the transducer element to the left from the transducer beam axial direction of the last one of the most sound pressure.

Great value distance between locations. For a circular plane without any means focusing transducer element, standard working distance of about equal Rao 2/lambda, which Lambda is the medium in the water and the operating frequency corresponding to the acoustic wavelength, Rao is the transducer element metallized area of a circle radius.

2.4 Beam axis

At a distance of more than the standard working distance of the ultrasound beam, the straight line connecting the measured spatial-peak amplitude of the sound pressure points (in accordance with the rules of the regression calculation).

For a non-focused transducer emitting acoustic beam must be doubled to twice the standard within the scope of the working distance at equal intervals to select these points.

For focused transducer (status unknown or focusing transducers) must be standard operating distance on both sides of the point (but no more than two of the distance Fold) in the lower lobe level at least 10dB maximum sound pressure amplitude than the center of the beam area next to any beam measured at equal intervals to select these points.

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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.

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