GB 10152-2009 English PDF (GB10152-2009)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get QUOTATION in 1-minute: Click GB 10152-2009
Historical versions: GB 10152-2009
Preview True-PDF (Reload/Scroll if blank)

GB 10152-2009: B mode ultrasonic diagnostic equipment
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 ...