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YY/T 0643-2008: Methods of meeasuring the performance of ultrasonic pulse-echo diagnostic equipment
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Methods of meeasuring the performance of ultrasonic pulse-echo diagnostic equipment
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YY/T 0643-2008
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Basic data | Standard ID | YY/T 0643-2008 (YY/T0643-2008) | | Description (Translated English) | Methods of meeasuring the performance of ultrasonic pulse-echo diagnostic equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.50; 17.140.50 | | Word Count Estimation | 19,142 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-06-01 | | Adopted Standard | IEC/TR 60854-1986, IDT | | Regulation (derived from) | SFDA [2008] No. 192 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the description of measuring pulse-echo medical diagnostic system performance parameters, and gives test methods. This standard applies to 0. 5MHz ~ 25MHz ultrasonic frequency range using a single array element transducer ultrasound diagnostic equipment. This standard does not apply to Doppler ultrasound systems. | YY/T 0643-2008: Methods of meeasuring the performance of ultrasonic pulse-echo diagnostic equipment
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Methods of meeasuring the performance of ultrasonic pulse-echo diagnostic equipment
ICS 11.040.50; 170.140.50
C41
Medical industry standards People's Republic of China
YY/T 0643-2008/IEC /TR60854. 1986
Ultrasonic pulse echo diagnostic device performance test methods
(IEC /T R60854. 1986, IDT)
Posted 2008-04-25
2009-06-01 implementation
State Food and Drug Administration issued
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.
This standard by the National Standardization Technical Committee medical ultrasound equipment.
This standard was drafted. medical ultrasound equipment Wuhan National Quality Supervision and Inspection Center.
The main drafters of this standard. white German study.
YY/T 0643-2008/IEC /TR60854. 1986
Ultrasonic pulse echo diagnostic device performance test methods
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
Made of a specific material capable of electrical energy into mechanical energy but also mechanical energy into electrical energy element.
2.2
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
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/λ, which
Λ 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
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.
YY/T 0643-2008/IEC /TR60854. 1986
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