GB 10152-2009 PDF English
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GB 10152-2009: PDF in English GB 10152-2009
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.40.55; 11.040.50
C 41
Replacing GB 10152-1997
B mode ultrasonic diagnostic equipment
B型超声诊断设备
ISSUED ON: NOVEMBER 15, 2009
IMPLEMENTED ON: DECEMBER 01, 2010
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine of PRC;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions... 6
4 Requirements ... 7
5 Test method ... 12
6 Inspection rules ... 18
Appendix A (Informative) Technical requirements for phantoms ... 20
Appendix B (Informative) B-ultrasonics setting for performance test ... 22
B mode ultrasonic diagnostic equipment
1 Scope
This standard specifies the definition, requirements, test methods, inspection rules of B
mode ultrasonic diagnostic equipment (hereinafter referred to as B-ultrasonics).
This standard applies to B mode ultrasound diagnostic equipment, which has a nominal
frequency in the range of 1.5 MHz ~ 15 MHz, including the two-dimensional grayscale
imaging part of color Doppler ultrasonic diagnostic equipment (color ultrasonics).
This standard does not apply to ophthalmic professional ultrasound diagnostic
equipment and intravascular ultrasound diagnostic equipment.
2 Normative references
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For the dated references, the subsequent amendments
(excluding corrections) or revisions do not apply to this Standard; however, parties who
reach an agreement based on this Standard are encouraged to study if the latest versions
of these documents are applicable. For undated references, the latest edition of the
referenced document applies.
GB 9706.1 Medical electrical equipment - Part 1: General requirements for safety
(GB 9706.1-2007, idt IEC 60601-1:1988)
GB 9706.9 Medical electrical equipment - Part 2-37: Particular requirements for the
safety of ultrasonic medical diagnostic and monitoring equipment (GB 9706.9-
2008, idt IEC 60601-2-37:2001)
GB 9706.15 Medical electrical equipment - Part 1-1: General requirements for
safety - Collateral standard: Safety requirements for medical electrical systems (GB
9706.15-2008, idt IEC 60601-1-1:2000)
GB/T 14710 Environmental requirement and test methods for medical electrical
equipment
YY/T 0108-2008 Testing methods for M-mode of ultrasonic diagnostic equipment
YY/T 1142-2003 Methods of measuring the frequency of medical ultrasonic
equipment and probe
The manufacturer shall publish the specification of slice thickness, in the accompanying
documents.
4.2.7 Accuracy of lateral geometrical position
The accuracy of lateral geometrical position shall meet the requirements of Table 1, OR
meet the manufacturer's published index, in the accompanying document. If the type
and nominal frequency of the probe are not included in the range, which is listed in
Table 1, the manufacturer shall publish the index of the probe, in the accompanying
document.
4.2.8 Accuracy of longitudinal geometrical position
The accuracy of longitudinal geometrical position shall meet the requirements of Table
1, OR meet the manufacturer's specifications, which are published in accompanying
documents. If the type and nominal frequency of the probe are not included in the range,
which is listed in Table 1, the manufacturer shall publish the index of the probe, in the
accompanying document.
4.2.9 Measurement deviation of perimeter and area
The measurement deviations of perimeter and area shall be within ±20%, OR in
accordance with the manufacturer's published specifications, in accompanying
documents.
4.2.10 M-mode performance index
For B-mode ultrasonic probes which have M mode, the performance test of M mode
time display error shall be carried out.
The performance index of M mode shall conform to the index, which is published by
the manufacturer, in the accompanying document.
4.2.11 Calculation deviation of 3D reconstruction volume
For B-ultrasonics, which are equipped with 3D reconstruction function, the deviation
of volume calculation shall be within the range of ±30%, OR in line with the index,
which is published by the manufacturer in the accompanying document.
4.2.12 Adaptable range of power supply voltage
Within the range of ±10% of the rated voltage, B-ultrasonics shall be able to work
normally.
4.2.13 Continuous operating time
The continuous operating time of B-ultrasonics shall be greater than 8 h.
The specified setting simulates the most commonly used state of B-ultrasonics in
clinical use. The clinical use state usually requires a deep penetration capability; the
focusing range of the ultrasonic beam is expanded as much as possible; it has the best
average resolution capability for the entire target.
The properties are tested at the nominal frequency of the probe.
For the variable frequency probe, set it at different nominal frequencies, according to
the instruction manual, to conduct the performance index test of the probe.
For broadband probes, the performance index of the probe shall meet the basic
performance requirements, within the frequency band corresponding to the probe's
center frequency.
For variable frequency probes or broadband probes, if the manufacturer has special
requirements in the instruction manual, the probe frequency can also be set to the
optimum state for testing, according to the requirements of the instruction manual.
5.2.2 Setting of B-ultrasonics during the test
The recommended test setup is as shown in Informative Appendix B.
This standard allows the manufacturer to specify the setting conditions of the B-
ultrasonics, during the performance test. However, the setting state of the B-ultrasonics
(focus, brightness, contrast, frequency, suppression, output power, gain, TGC,
automatic TGC, etc.), in the test report, shall be published, together with the test results.
5.3 Performance test
5.3.1 Acoustic operating frequency test
The measurement of the acoustic operating frequency and frequency range shall be
carried out, in accordance with the provisions of YY/T 1142.
5.3.2 Penetration depth test
Turn on the B-ultrasonics to be tested. Place the probe on the surface of the phantom
acoustic window, through the couplant. Aim at the longitudinal depth target group.
Keep the target line image clearly visible, under the specified setting conditions. Move
the probe slightly, to observe the target line on the image, which is farthest from the
surface of the probe, that can be distinguished. The distance, between the target line and
the probe surface, is the penetration depth of the probe.
5.3.3 Lateral resolution test
Turn on the B-ultrasonics to be tested. Place the probe on the surface of the phantom
acoustic window, through the couplant. Aim at the lateral resolution target group, at a
specific depth. Keep the target line image clearly visible, under the specified setting
conditions. Move the probe slightly. The minimum distance, between the two target
lines, that can be displayed separately as two echo signals, is the lateral resolution at
this depth.
If the lateral resolution requires multiple target groups within the specified depth range,
it shall test each target group separately; take the maximum value of the test results as
the lateral resolution of the probe; meanwhile record the testing data of all target groups,
within the depth range.
5.3.4 Axial resolution test
Turn on the B-ultrasonics to be tested. Place the probe on the surface of the phantom
acoustic window, through the couplant. Aim at the axial resolution target group, at a
specific depth. Under the specified setting conditions, keep the target line image clearly
visible. Move the probe slightly. The minimum distance, between the two target lines,
that can be displayed separately as two echo signals, is the axial resolution at this depth.
If the axial resolution requires multiple target groups, within the specified depth range,
each target group shall be tested separately. Take the maximum value of the test results,
as the axial resolution of the probe. Meanwhile record the testing data of all target
groups, within the depth range.
5.3.5 Dead zone test
Turn on the B-ultrasonics to be tested. Place the probe on the surface of the phantom
acoustic window, through the couplant. Aim at the target group in the dead zone. Keep
the target line image clearly visible, under the specified setting conditions. Translate the
probe, to observe the target line, which is closest to the probe surface AND the image
behind of which can be distinguished. The distance, between the target line and the
probe surface, is the dead zone of the probe.
5.3.6 Slice thickness test
Turn on the B-ultrasonics to be tested. Place the probe on the surface of the phantom
acoustic window, through the couplant. Aim at the thin layer of the scattering target.
The scanning plane is perpendicular to the ultrasonic phantom window. The intersection
line, between the scanning plane and the phantom window, is parallel to the thin
scattering target layer, as shown in Figure 1. Under the specified setting conditions,
adjust the intersection line of the scanning plane and the thin scattering target layer, to
locate it at a specific depth. Use an electronic vernier, to measure the thickness of the
thin scattering target layer. Calculate the slice thickness t at this depth (see Figure 1).
target groups. Keep the target group images clearly visible, under the specified setting
conditions. Keep the center of the target group in the center of the field of view. Draw
a closed figure (rectangle or circle), in the area of the displayed center, which is
approximately equal to 75% of the field of view. Measure the perimeter and area.
Calculate the percentage error.
5.3.10 M-mode performance test
The performance test of B-ultrasonic M mode is carried out, in accordance with the
provisions of YY/T 0108.
5.3.11 Calculation deviation of 3D reconstruction volume
Turn on the B-ultrasonics to be tested. Place the probe on the surface of the acoustic
window of the ultrasonic phantom, through the couplant. Scan the oval target of known
volume value. Follow the three-dimensional reconstruction volume steps and volume
measurement steps, under the specified setting conditions, to obtain the measured
volume of the oval target. Calculate the percentage error; the deviation shall be within
±30%.
5.3.12 Adaptable range of power supply voltage
Set the power supply voltage at 110% and 90% of the rated value, respectively. The
equipment shall work normally.
5.3.13 Continuous operating time
B-ultrasonic is in the operating state of scanning and displaying. It shall be able to work
normally, after 8 hours of continuous startup.
If the B-ultrasonic is an internal power supply device, the continuous operating time
test shall be carried out, according to the index, which is published by the manufacturer,
in the accompanying document.
If the manufacturer specifies the operation requirements of the probe, in the
accompanying document, then during the continuous operating time test, the operation
duration rate of the probe shall be carried out, according to the manufacturer's
requirements.
5.4 Safety test
The general safety requirements of B-ultrasonics shall be implemented, in accordance
with the provisions of GB 9706.1.
If applicable, the system safety requirements of B-ultrasonics shall be implemented, in
accordance with the provisions of GB 9706.15.
The special safety requirements for B-ultrasonics shall be implemented, in accordance
with the provisions of GB 9706.9.
5.5 Appearance and structural inspection
It is verified by visual observation and practical operation.
5.6 Use function inspection
Check the main functions one by one, according to the provisions of the instruction
manual of the B-ultrasonics to be tested, to verify whether it can work normally.
Note: The use function inspection does not include product design parameters or
functional items, that cannot be verified by intuitive test means.
5.7 Environmental test
The environmental test of B-ultrasonics shall be carried out, according to the methods
and procedures, which are specified in GB/T 14710. The test time and conditions shall
comply with the supplementary provisions of Table 2.
6 Inspection rules
6.1 Inspection classification
Product inspection is divided into exit-factory inspection and type inspection.
6.2 Exit-factory inspection
The inspection items and judgment rules of the exit-factory inspection are stipulated by
the manufacturer.
6.3 Type inspection
6.3.1 Type inspection shall be carried out, in one of the following situations:
a) Registration inspection;
b) Not less than once a year, in continuous production;
c) Production resumed after long-term shutdown;
d) When there are major changes in design, process or materials, that may cause
changes in the safety or performance of B-ultrasonics;
e) When requested by the national quality supervision and inspection department.
6.3.2 The items of the type test are all the required items of this standard; the number
of samples for the type test is one set.
Appendix A
(Informative)
Technical requirements for phantoms
A.1 Technical requirements for general phantoms
When carrying out the test of B-ultrasonics dead zone, penetration depth, axial
resolution, lateral resolution, accuracy of longitudinal and lateral geometrical position,
the technical parameters of the phantom, which is used in the test, are as follows:
Sound velocity of tissue-mimicking material: 1540 m/s ± 10 m/s, 23 °C ± 3 °C;
Sound attenuation of tissue-mimicking material: 0.7 dB/(cm·MHz) ± 0.05
dB/(cm·MHz), 23 °C ± 3 °C;
Nylon target wire's diameter: 0.3 mm ± 0.05 mm;
Target line's position tolerance: ±0.1 mm;
The spacing between adjacent target lines, in the longitudinal linear target group: 10
mm;
The spacing between adjacent target lines, in the lateral linear target group: 10 mm
or 20 mm;
The depth of the resolution target group shall be able to meet the test needs.
A.2 Technical requirements for slice thickness phantoms
Sound velocity of background tissue-mimicking material: 1540 m/s ± 10 m/s, 23 °C
± 3 °C;
Sound attenuation of background tissue-mimicking material: 0.7 dB (cm·MHz) ±
0.05 dB/(cm·MHz), 23 °C ± 3 °C;
Scattering target's layer thickness: Not more than 0.4 mm.
A.3 Technical requirements for volumetric phantoms
Sound velocity of background material: 1540 m/s ± 10 m/s, 23 °C ± 3 °C;
Sound speed of ovoid material: 1540 m/s ± 10 m/s, 23 °C ± 3 °C;
At a minimum, it shall indicate the volume data for calibrated ovoid.
Appendix B
(Informative)
B-ultrasonics setting for performance test
B.1 Test setup
B.1.1 Overview
Various combinations of B-ultrasonics settings and probes make it impossible to test in
all combinations. Therefore, for each probe, it is only tested at the specified settings.
The prescribed settings are similar to the probes, which are most commonly used in
clinical use; the simulating clinical use often requires deeper probing capabilities. B-
ultrasonic is set by the following steps; the focusing range of the ultrasonic beam is
expanded as much as possible; it has the best average resolution for the entire target, to
achieve the best scanning state for common soft tissue structures. Initially, the phantom
is imaged, using the typical B-ultrasonic settings for imaging soft tissue. Follow the
steps of B.1.2 ~ B.1.4, to carry out the test setup.
B.1.2 Display settings (focus, brightness, contrast)
Turn the brightness and contrast controls all the way down, focus to sharp. Then
increase the brightness, until it becomes the lowest perceptible grayscale, in the echo-
free areas around the edges of the image. Then increase the contrast, so that the image
contains the largest possible grayscale range. Finally, check the sharpness of the focus.
If further adjustments are required, repeat the entire procedure.
B.1.3 Sensitivity setting (frequency, suppression, output power, gain, TGC,
automatic TGC)
The sensitivity setting shall meet the following requirements:
a) Indicate the nominal frequency of the B-ultrasonic probe;
b) If there is a suppression or limitation control terminal, it is adjusted, so that the
smallest possible signal can be displayed;
c) The output power and gain shall be set to the maximum value, to obtain the echo
signal at the maximum depth, in the highly attenuated scattering material; the
small ultrasonic echo shall be distinguishable from electrical noise;
d) The adjustment of the near-field gain level of the Time Gain Compensation (TGC)
control terminal should make the echo signal, within the initial 1 cm or 2 cm range
in the phantom, display a medium gray level;
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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