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YY/T 1694-2020 English PDF (YYT1694-2020)

YY/T 1694-2020 English PDF (YYT1694-2020)

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YY/T 1694-2020: Optical positioning device for radiation therapy--Performance and test methods

This standard specifies the performance and test methods of optical positioning device for radiation therapy. This standard applies to the optical positioning device for radiation therapy, by optical methods (including visible light, infrared light, laser, etc.).
YY/T 1694-2020
YY
PHARMACEUTICALS INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.60
C 43
Optical positioning device for radiation therapy ?€?
Performance and test methods
ISSUED ON: FEBRUARY 21, 2020
IMPLEMENTED ON: JUNE 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Requirements ... 4
4.1 Accompanying documents ... 4
4.2 Field of view ... 5
4.3 Positioning accuracy ... 6
4.4 Position repeatability ... 6
4.5 System data refresh frequency ... 6
4.6 Drift ... 6
4.7 Equipment functions ... 6
5 Test method ... 7
5.1 Accompanying documents ... 7
5.2 Field of view ... 7
5.3 Positioning accuracy ... 7
5.4 Positioning repeatability ... 9
5.5 System data refresh frequency ... 10
5.6 Drift ... 10
5.7 Device functions ... 10
Appendix A (Informative) Application descriptions for optical positioning device ... 11 Optical positioning device for radiation therapy ?€?
Performance and test methods
1 Scope
This standard specifies the performance and test methods of optical positioning device for radiation therapy.
This standard applies to the optical positioning device for radiation therapy, by optical methods (including visible light, infrared light, laser, etc.).
2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this standard.
GB/T 18987-2015 Radiotherapy equipment - Coordinates, movements and scales 3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Isocenter
In radiology equipment, the reference axes of various movements move around a common center point, meanwhile the radiation beam passes through the smallest sphere centered on this point, which is the isocenter.
[GB/T 17857-1999, definition 3.2.50]
4 Requirements
4.1 Accompanying documents
Accompanying documents shall contain the following:
a) Model and manufacturer;
b) Type of imaging detection equipment;
c) Positioning method and type (such as using infrared light, visible light, etc.); d) Registration algorithms and/or methods;
e) The coordinate system used, as well as the conversion relationship between the coordinate system and the coordinate system specified in the GB/T 18987-2015 system;
f) Field of view;
g) Quality control methods (at least including self-calibration methods), frequency and tools used;
Note: The quality control content of factors affecting positioning accuracy other than optical positioning device (see Appendix A) is not within the scope of this standard. h) Typical test conditions for positioning correction (including but not limited to: CT planning image scanning conditions, reference images, image reconstruction algorithms, image registration algorithms, etc.);
Note: Typical test conditions are a group of commonly used clinical test conditions. i) If a marker is used, its possible influence on the therapeutic radiation shall be indicated;
j) Equipment warm-up (stabilization) time;
k) Basic parameters of the light source used;
l) Installation requirements for optical positioning device, that is, installation deviation requirements between the reference point of the optical positioning device and the isocenter or reference point of the treatment equipment; m) Refresh frequency of optical positioning device.
4.2 Field of view
The technical requirements for medical device products shall specify the field of view of the optical positioning device in the three directions of X, Y, Z.
information, plan information, relationship between positioning marks and positioning reference points, treatment progress.
c) Positioning and monitoring
It shall have the following functions:
1) Collect and store body surface information;
2) Record the positioning deviation during the treatment.
d) Data report output
It shall be able to output data and generate documentation.
5 Test method
5.1 Accompanying documents
Check the accompanying documents, which shall meet the requirements of 4.1. 5.2 Field of view
Place the markers, according to the manufacturer's requirements. Move the markers along the two directions of the X-axis. Use the optical positioning device, to continuously record the coordinates of the markers. Find the coordinates of the two farthest markers in the direction of the X-axis. Then use this method, to find the coordinate values of the two farthest markers in the direction of the Y axis and the Z axis, respectively.
According to the coordinate values of the two farthest markers in the three directions of X-axis, Y-axis, Z-axis, obtain the field of view of the optical positioning device; the results shall meet the requirements of 4.2.
5.3 Positioning accuracy
5.3.1 Test phantom
a) Basic requirements
The following conditions shall be met:
1) Due to the different markers and identification technologies used in the optical positioning device, this test allows the use of different types of phantoms; the selection of simulation models shall meet the requirements of this test verification.
2) The simulation model shall at least have the corresponding body surface structure, so as to be able to simulate the use situation of clinical optical positioning device.
b) Setting of marker points
Set 5 marker points in the simulation model, one of which is located at the approximate center of the simulation model, denoted as P0 (x0, y0, z0). The other 4 marker points are not coplanar; the coordinate positions are fixed relative to P0 (x0, y0, z0), denoted as Pi (xi, yi, zi), i = 1, 2, 3, 4; the relative distance between each point and P0 is not less than 25 mm.
5.3.2 Test method
Under the typical test conditions specified by the manufacturer, to carry out the test, in accordance with the following steps:
a) Fix the simulation model on the CT bed. Scan according to the typical scanning conditions, which is specified by the optical positioning device manufacturer, to obtain CT images.
b) Select a typical reference image reconstruction algorithm, to reconstruct the CT image obtained above. Select the P0 (x0, y0, z0) point in the simulation model, as the target point.
c) Start the optical positioning device.
d) Adjust the simulation model. Place the marker point P0 of the simulation model at the approximate isocenter (or treatment reference point). Detect and record the coordinates of the marker point P0 as R0,0 (x0,0, y0,0, z0,0); the coordinates of the other four points are Ri,0 (xi,0, yi,0, zi,0), i = 1, 2, 3, 4.
e) Translate the simulation model by ??d (d, d, d).
Note: d is 15 mm.
f) Detect and record the coordinates of the marker point P0 as R0,1 (x0,1, y0,1, z0,1); the coordinates of the other four points are Ri,1 (xi,1, yi,1, zi,1), i = 1, 2, 3, 4. g) Perform positioning calculation, through a typical registration algorithm, to obtain the coordinates R?€?0,1 (x?€?0,1, y?€?0,1, z?€?0,1) of the marked point P0. Calculate the deviation -- between R?€?0,1 and its corresponding actual position R0,1, according to formula (1):
5.5 System data refresh frequency
5.5.1 Test phantom
Same as 5.3.1.
5.5.2 Test procedure
Under the typical test conditions specified by the manufacturer, the test is carried out in accordance with the following steps:
a) Use the optical positioning device, to collect real-time 1-min position coordinate data; save the collection results (including time Ti and position Pi).
b) Calculate the time difference ??Ti = Ti - Ti-1 between adjacent position data Pi and Pi-1 in the collection results.
c) The maximum value of ??Ti shall meet the requirements of 4.5.
5.6 Drift
A mark is fixed within the monitoring range of the optical positioning device. After the system is turned on, the mark position is determined and recorded once every minute, to generate the system drift curve. The time elapsed from the start-up to the stable mark position is the start-up time.
After the system is stable, record the marker position once, denoted as P0 (X0, Y0, Z0). Then within 8 hours, determine and record the marker position once every 30 min, denoted as Pi (Xi, Yi, Zi), i = 1, 2, 3, ..., 16. Calculate the maximum deviation value ??D (??X, ??Y, ??Z) between Pi and P0. The result shall meet the requirements of 4.6. 5.7 Device functions
The actual operation verification shall meet the requirements of 4.7.

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