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YY/T 1676-2020 English PDF (YYT1676-2020)

YY/T 1676-2020 English PDF (YYT1676-2020)

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YY/T 1676-2020: Ultrasound endoscope

This Standard specifies terms and definitions, requirements and test methods of the ultrasonic endoscope related to the ultrasonic performance part. This Standard is applicable to ultrasound endoscope and ultrasound probe that extends into the body through the endoscope tube.
YY/T 1676-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.55
C 41
Ultrasound endoscope
???????????????
ISSUED ON: MARCH 31, 2020
IMPLEMENTED ON: OCTOBER 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Requirements ... 6
5 Test methods ... 8
Annex A (informative) Technical requirements for phantom and/or test piece 15 Ultrasound endoscope
1 Scope
This Standard specifies terms and definitions, requirements and test methods of the ultrasonic endoscope related to the ultrasonic performance part. This Standard is applicable to ultrasound endoscope and ultrasound probe that extends into the body through the endoscope tube.
NOTE: There are many types of ultrasound transducers for current ultrasound endoscopes and ultrasound probes, such as single element rotation, ring array and convex array. This Standard does not consider the appearance and structure of the probe. The test method of parameters takes the rotation of single element, ring array and convex array imaging as examples. If necessary, more complex designs can also use the basic methods described in this Standard.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 9706.1, Medical electrical equipment - Part 1: General requirements for safety
GB 9706.9, Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment GB 10152, B mode ultrasonic diagnostic equipment
GB/T 14710, Environmental requirement and test methods for medical
electrical equipment
YY/T 0108, Testing methods for M-mode of ultrasonic diagnostic equipment YY 0767, Ultrasonic color flow imaging systems
YY/T 1279, Test method for performance of three-dimensional
ultrasonography
YY/T 1420, Environmental requirement and test methods for medical
ultrasonic equipment
4.5 Blind zone
The blind zone shall meet the requirements published by the manufacturer in the accompanying documents.
4.6 Slice thickness
If applicable, the slice thickness shall meet the requirements published by the manufacturer in the accompanying documents.
4.7 Accuracy of horizontal geometric position accuracy
For single-element rotating probe, the accuracy of lateral geometric position shall be ???10%.
For ring array probe and convex array probe, the accuracy of horizontal geometric position shall be ???5%.
4.8 Accuracy of longitudinal geometric position
For single-element rotating probe, the accuracy of longitudinal geometric position shall be ???10%.
For ring array probe and convex array probe, the accuracy of longitudinal geometric position shall be ???5%.
4.9 Perimeter and area measurement deviation
If applicable, the deviation of perimeter and area measurement shall be within ??20%, or meet the requirements published by the manufacturer in the
accompanying documents.
4.10 M mode performance indicators
For type-B ultrasound probes with M mode, the performance indicators of its M mode shall meet the requirements published by the manufacturer in the
accompanying documents.
4.11 3D imaging performance
For equipment with 3D imaging function, its 3D imaging performance indicators (if applicable) shall meet the requirements specified in YY/T 1279.
4.12 Geometric position accuracy in pullback direction
If applicable, the geometric position accuracy in pullback direction shall meet the requirements published by the manufacturer.
4.13 Ultrasound imaging geometric distortion
Turn on the device under test. Align the probe at the longitudinal depth target group. Under the specified setting conditions, keep the target line image clearly visible. Slightly move the probe. Observe the target line where the image can be resolved farthest from the probe surface. The distance between the target line and the probe surface is the detection depth of the probe.
5.4 Lateral resolution
Turn on the device under test. Align the probe at a specific depth of the lateral resolution target group. Under the specified setting conditions, keep the target line image clearly visible. Slightly move the probe. The minimum distance between two target lines that can be separately displayed as two echo signals is the lateral resolution at that depth.
For different nominal detection depths, it is recommended to measure the lateral resolution according to the following depth positions:
a) When nominal detection depth is ???3cm, it is specified by the manufacturer. Measure at two positions within 1/2 and outside 1/2 of the nominal
detection depth. Take odd centimeters;
b) When 1cm???nominal detection depth< 3cm, only measure the lateral
resolution at the detection depth of 1cm;
c) When nominal detection depth is < 1cm, a measurement location is
specified by the manufacturer.
5.5 Axial resolution
Turn on the device under test. Align the probe to a target group of axial resolution at a specific depth. Under the specified setting conditions, keep the target line image clearly visible. Slightly move the probe. The minimum distance between two target lines that can be separately displayed as two echo signals is the axial resolution at that depth.
For different nominal detection depths, it is recommended to measure the axial resolution according to the following depth positions:
a) When nominal detection depth is ???3cm, measure outside the lateral
resolution measurement position;
b) When 1cm???nominal detection depth< 3cm, only measure the axial
resolution of the detection depth < 2cm;
c) When nominal detection depth is < 1cm, a measurement location is
specified by the manufacturer.
5.6 Blind zone
to an appropriate value.
The accuracy of lateral geometric position is usually expressed as a percentage. 5.9 Accuracy of longitudinal geometric position
Turn on the tested type-B ultrasound. Align the probe to the longitudinal linear target group. Under the specified setting conditions, keep the target group image clearly visible. Use the device's ranging function. In the full screen range according to the longitudinal known distance, calculate the accuracy of axial geometric position according to formula (1).
The accuracy of longitudinal geometric position is usually expressed as a percentage.
5.10 Perimeter and area measurement deviation
Turn on the device under test. Scan the horizontal and vertical linear target groups with the probe. Under the specified setting conditions, keep the target group image clearly visible. Maintain the center of the target group in the center of the field of view. Draw a closed figure (rectangular or circular) in an area approximately equal to 75% of the field of view in the center of the display. Measure the perimeter and the area. Calculate the error according to formula (1).
5.11 M mode performance indicators
The performance test of the equipment M mode is carried out in accordance with the provisions of YY/T 0108.
5.12 3D imaging performance
The test method for 3D imaging performance is implemented in accordance with YY/T 1279.
5.13 Geometric position accuracy in pullback direction
Turn on the device under test. Measure two target lines with known distances at the middle of the pullback area specified by the manufacturer. Under the specified setting conditions, keep the target group image clearly visible. Use the device's ranging function to measure. Calculate the geometric position accuracy in the pullback direction according to formula (1).
The geometric position accuracy in the pullback direction is usually expressed as a percentage.
During the test, the pullback speed of the ultrasonic transducer assembly shall be recorded.
Annex A
(informative)
Technical requirements for phantom and/or test piece
A.1 Phantom
A.1.1 Technical requirements for general phantom
During the tests in 5.2~5.16, the technical parameters of the phantom used for testing are as follows:
Sound velocity of tissue-like materials: (1540??10)m/s (23??C??3??C);
Sound attenuation of tissue-like materials: (0.7??0.05)dB/(cm??MHz) (23??C??3??C); Nylon target line diameter: (0.3??0.05) mm;
Target line position tolerance: ??0.1mm;
Distance between adjacent target lines in longitudinal linear target group: 10mm; Distance between adjacent target lines in horizontal linear target group: 10mm or 20mm.
The depth of the resolution target group shall be able to meet the test needs. A.1.2 Technical requirements for slice thickness phantom
During the test in 5.7, the technical parameters of the phantom used for testing are as follows:
Background sound velocity of tissue-like material: (1540??10)m/s(23??C??3??C); Background sound attenuation of tissue-like materials:
(0.7??0.05)dB/(cm??MHz)( 23??C??3??C);
Scattering target layer thickness: no more than 0.4mm.
A.1.3 Technical requirements for phantom for volume measurement
During the test in 5.12, the technical parameters of the phantom used for testing are as follows:
Sound velocity of background material: (1540??10)m/s (23??C??3??C);

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