YY/T 1676-2020Ultrasound endoscope (English PDF)

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

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.

4.12 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.

5.13 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.

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);