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1、J IS JAPANESE I N DUSTR IAL STANDARD Translated and Published by Japanese Standards Association (Reaffirmed : 1995) General methods of measuring the performances of ultrasonic Pulse-echo diagnostic equipment ICs 11.040.55 Descriptors : ultrasonics, diagnosis (medical), medical equipment, ultrasonic
2、medical apparatus, electrical medical equipment, performance testing, mechanical testing, electrical testing, electrical equipment Reference number : JIS T 1501 : 1984 (E) 10 s PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employee
3、s/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 22:13:46 MDTNo reproduction or networking permitted without license from IHS -,-,- T 1501 : 1984 Foreword This translation has been made based on the original Japanese Industrial Standard revised by the Minister of Health and Welfare, and th
4、e Minister of International Trade and Industry through deliberations at the Japanese Industrial Standards Committee in accordance with the Industrial Standardization Law: Date of Establishment: 1984-07-01 Date of Reaffirmation: 1995-05-15 Date of Public Notice in Official Gazette: 1995-07-13 Investi
5、gated by: Japanese Industrial Standards Committee Divisional Council on Electronics Technical Committee on Medical Equipment and Systems JIS T 1501 : 1984, First English edition published in 2002-07 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-84
6、40 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. O JSA 2002 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photoc
7、opying and microfilm, without permission in writing from the publisher. Printed in Japan PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 22:13:46 MDTNo reproduction o
8、r networking permitted without license from IHS -,-,- Contents T 1501 : 1984 Page 1 2 3 4 4.1 4.2 4.3 4.4 5 5.1 5.2 5.3 6 7 8 8.1 8.2 8.3 8.4 Scope Definitions Measuring items Measuring method of overall sensitivity . General Measuring method of maximum overall sensitivity of A-mode ultrasonic diagn
9、ostic equipment . Measuring method of maximum overall sensitivity of B-mode ultrasonic diagnostic equipment . Measuring method of maximum overall sensitivity of M-mode ultrasonic diagnostic equipment . Measuring method of resolution . General Measuring method of axial resolution . Measuring method o
10、f lateral resolution Measuring method of ultrasound frequency . Measuring method of ultrasound output Measuring method of display accuracy . Measuring items Measuring method of distance accuracy . Measuring method of relative position accuracy . Measuring method of composite accuracy . 1 1 3 3 3 4 4
11、 5 5 5 6 6 7 8 10 10 10 10 11 PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 22:13:46 MDTNo reproduction or networking permitted without license from IHS -,-,- JAPAN
12、ESE INDUSTRIAL STANDARD JIS T 1501 : 1984 General methods of measuring the performances of ultrasonic pulse-echo diagnostic equipment 1 Scope This Japanese Industrial Standard specifies basic matters with regard to measurement of the performances of the ultrasonic pulse-echo diagnostic equipment des
13、igned to operate at the frequency range of 1 MHz to 10 MHz using a single probe. 2 Definitions For the purposes of this Standard the following definitions shall apply. pulse echo method The diagnostic method by using ultrasound reflected from the acoustic discontinuous part or the acoustic inhomogen
14、eous part of the sample under test when ultrasound pulse enters. A-mode A method of data presentation of echo information in which the variation of echo amplitudes is represented versus time on the display of cathode-ray tube or on the record paper. B-mode A method of data presentation of echo infor
15、mation in which echo amplitude is represented versus time in the form of local brightness or optical density on the display of CRT. M-mode A method of data presentation of echo information in which the dis- tance between a echo source and the probe fixed is represented on one axis and time on the ot
16、her axis. echo The ultrasound pulse received after being reflected by the sample under test. beam the sound wave directivity. multiple echo A phenomenon that ultrasound radiated from a transducer is reflected repeatedly between the transducer and target objects. Langevin radiation force ies in the f
17、ree sound field are subjected. A bundle of ultrasound radiated in a certain direction, being focused by Radiation force to which pressure receiving bod- pulse repetition period The time interval of repetition of the ultrasound pulse radiation. (10) transducer A device that converts electric vibratio
18、n to mechanical vibration (ultrasound) and vice versa. (11) probe A probe including the transducer for transmitting and receiving ul- trasound and the attached mechanisms (damper materials, coils, etc.). (12) radiation area An area of the sound source (transducer) of the probe. Normative reference:
19、JIS B 1501 Steel balls for ball bearings PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 22:13:46 MDTNo reproduction or networking permitted without license from IHS
20、-,-,- 2 T 1501 : 1984 contact medium A medium which fills space between the transducer and the objects concerned to create the sound field of ultrasound. reflection loss Quantity expressing the magnitude of reflection of the reflec- tor. It is expressed in terms of difference in level between the ec
21、ho which the probe receives from a reflector and the echo which the probe receives from the flat perfect reflector located at the same distance as that from the reflector. dynamic range The range of input (voltage, etc.) over which the echo, etc. can be amplified or expressed without being buried in
22、 noise and saturated. It is normally expressed in decibels (dB). maximum overall sensitivity The total performance comprehending the trans- mitting output of equipment, gain of receivers, efficiency of the probe, perfor- mance of the display, etc. It is the maximum capability of equipment to detect
23、and indicate the target reflector. resolution The capability to indicate separation of the reflections from two adjacent parts. It is the minimum distance between the two adjacent points that are distinctly recognizable on the display. sensitivity adjustor The adjustor designed to adjust the sensiti
24、vity of equip- ment. attenuator The adjustor designed to adjust quantitatively the sensitivity of equipment. in vivo conversion distance The distance or depth in a living body calcu- lated from the propagation time on condition that ultrasound propagates in a living body at a constant speed, when ul
25、trasound enters a living body. preset sound velocity The assumption value of the mean sound velocity in a living body which is used in calculating in vivo conversion distance. sensitivity time control (STC) To adjust and correct attenuation, etc. of echo caused by the distance, changing the amplitud
26、e gain with time during one sweep. It is also called TGC. fast time constant circuit (FTC) To strengthen the receiving echo accord- ing to the velocity of the amplitude change caused by the distance. rejection appear an the display of CRT or on the record paper. To remove weak echos under a certain
27、level so that they do not special adjustment mechanism The inclusive name of the adjustment mecha- nism such as STC, FTC, rejection. ultrasound output unit time. Total energy of ultrasound radiated from the probe per ultrasound output per unit area vided by the radiation area of the transmitting tra
28、nsducer element. grey scale A range of values of image brightness, being either continuous between two extreme values (black and white level) or, if discontinuous, in- cluding at least three discrete values (grey) The value of the ultrasound output di- PROTECTED BY COPYRIGHT Copyright Japanese Stand
29、ards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 22:13:46 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 T 1501 : 1984 Dimension of steel ball Diameter mm 2.381 2 (3/32) (I) 1.587 5 (1/
30、16)(1) 3 Measuring items The measuring items shall be as follows: (1) Maximum overall sensitivity (2) Resolution (3) Ultrasound frequency (4) Ultrasound output (5) Display accuracy Value of reflection loss (2) dB 44.5 48.0 4 Measuring method of overall sensitivity 4.1 General The general matters sha
31、ll be as follows: (1) For the overall sensitivity measurement of equipment specified in this Standard, a steel ball having the value of reflection loss shown in Table 1 shall be used as the standard reflector. The overall sensitivity is expressed in decibels (dB). PROTECTED BY COPYRIGHT Copyright Ja
32、panese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 22:13:46 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 T 1501 : 1984 (4) The measurement of the overall sensitivity shall b
33、e performed, as a rule, with the special adjustment mechanism (STC, FTC, rejection, etc.) of the equipment under measurement set at “zero” or “off”. 4.2 Measuring method of maximum overall sensitivity of A-mode ultrasonic diagnostic equipment When the amplitude of echos from the standard reflector i
34、ndicated in the equipment under measurement is half the effective echo height of the equipment under measurement, consider the sensitivity of the equipment under measurement as a reference (which is equal to the value of reflection loss of the standard reflector used), and define this reference plus
35、 the sensitivity allowance of the equip- ment under measurement until the noise amplitude reaches 5 % of the effective echo height of the equipment under measurement as the maximum overall sensitivity of the equipment under measurement. 4.3 diagnostic equipment B-mode ultrasonic diagnostic equipment
36、 shall be as follows: (1) Measuring method of maximum overall sensitivity of B-mode ultrasonic The measuring method of maximum overall sensitivity of The equipment under measurement shall be separated into the display unit and the transmittedreceiver, and the measurement shall be performed. The disp
37、lay unit shall be operated under sweep conditions near to that of speci- fications in the equipment under measurement and the brightness signal shall be inputted using the step signal generator, etc. and the input voltage indicat- ing the middle brightness shall be determined. This input voltage sha
38、ll be defined as “standard picture input voltage (E,)”. Then, the maximum value of the in- put voltage without showing the luminescent spot in the display unit shall be determined. This shall be defined as “black level input voltage (E,)” (see Fig. 1). (2) I I I Display unit brightness l 1 - input v
39、oltage 0. 0 Es - Transmitterheceiver brightness output voltage il 1 - s t a n d a r d reiector echo signai Fig. 1 Relationship between display unit brightness input and transmittedreceiver brightness output PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license
40、 with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/14/2007 22:13:46 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 T 1501 : 1984 (3) The measurement shall be performed with the transmitterheceiver of the equip- ment under measurement and the
41、 standard reflector combined. The sensitivity adjustor of the equipment under measurement shall be adjusted so that the signal amplitude of echo signal from the standard reflector caused by brightness out- put of the transmitterheceiver of the equipment under measurement is equal to the standard pic
42、ture input voltage (E,) specified in (2). Consider the sensi- tivity of the equipment under measurement under this condition as a reference (which is equal to the value of reflection loss of the standard reflector used expressed in decibels), and define this reference plus the sensitivity allowance
43、(3) up to the time when the noise amplitude of the brightness output reaches half the black level input voltage (E,) specified in (2) as the maximum overall sen- sitivity of the equipment under measurement (see Fig. 1). Note (3) Actual measurement shall be performed by using the attenuator with the
44、maximum sensitivity of the equipment under measurement set at “O” dB. Therefore, the sensitivity allowance of this equipment under measurement is A dB where the noise amplitude is % or under, although the reading indicated by the attenuator is “A” dB and the attenuator is set at “O” dB under the con
45、dition of the reference (when the echo signal amplitude of the standard reflector is equal to Ed. If the noise amplitude of the brightness output becomes or over when the attenuator is set at “O” dB, the attenuator is adjusted so that the noise amplitude is set to T . tivity allowance of the equipme
46、nt under measurement is (A - B) dB. E O If the reading of the attenuator at this point is “B” dB, the sensi- The maximum overall sensitivity, S, of the equipment under measurement, where the value of reflection loss of the standard reflector used is C, shall be in accordance with the following formu
47、la. S, (dB) =A - B + C 4.4 Measuring method of maximum overall sensitivity of M-mode ultrasonic diagnostic equipment Consider the sensitivity of the equipment under measure- ment when the amplitude of the echo signal (which is equal to the brightness signal inputted to the display unit) of the stand
48、ard reflector outputted from the equipment under measurement is half the saturated value of the brightness signal as a refer- ence (the sensitivity equal to the value of reflection loss of the standard reflector used). This reference plus the sensitivity allowance of the equipment up to the time when the noise signal reaches 5 % of the saturated value of the brightness signal of the equipment under measurement shall be defined as the maximum overall sensi- tivity of the equipment under measurement. 5 Measuring method of resolution 5.1 General General matters shall be as follows