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YY/T 1694-2020: Optical positioning device for radiation therapy - Performance and test methods
YY/T 1694-2020
Optical positioning device for radiation therapy--Performance and test methods
ICS 11.040.60
C43
People's Republic of China Pharmaceutical Industry Standard
Optical positioning equipment for body surface for radiotherapy
Performance and test methods
2020-02-21 released
2021-06-01 implementation
Issued by the State Drug Administration
Table of contents
Preface Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Requirements 1
4.1 Random file 1
4.2 Field of view 2
4.3 Positioning accuracy 2
4.4 Position repeatability 2
4.5 System data refresh frequency 2
4.6 Drift 2
4.7 Device function 2
5 Test method 3
5.1 Random file 3
5.2 Field of view 3
5.3 Positioning accuracy 3
5.4 Position repeatability 4
5.5 System data refresh frequency 4
5.6 Drift 4
5.7 Device function 4
Appendix A (informative appendix) Application Note of Body Surface Optical Positioning Equipment 5
Preface
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is organized by the National Medical Electrical Appliance Standardization Technical Committee Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment Sub-Technical Committee
(SAC/TC10/SC3) Centralized.
Drafting organizations of this standard. Beijing Institute of Medical Device Inspection, Nanjing University, Beijing Huiren Haitai Innovative Medical Technology Service Co., Ltd., Jiang
Surel Medical Technology Co., Ltd.
The main drafters of this standard. Zheng Lifu, Ge Yun, Xie Soldier, Wang Huiliang, Fu Dongshan.
Optical positioning equipment for body surface for radiotherapy
Performance and test methods
1 Scope
This standard specifies the performance and test methods of body surface optical positioning equipment for radiotherapy.
This standard applies to the optical positioning of the body surface for radiotherapy by optical methods (including visible light, infrared light, laser, etc.)
equipment.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 18987-2015 Radiotherapy equipment coordinates, movement and scale
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Isocenter
In radiology equipment, the reference axis of various movements moves around a common center point, and the radiation beam is inside the smallest sphere centered on this point.
Pass, this point is the isocenter.
[GB/T 17857-1999, definition 3.2.50]
4 requirements
4.1 Random files
The random file should 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 algorithm and/or method;
e) The coordinate system used, and the conversion relationship between the coordinate system and the coordinate system specified in the GB/T 18987-2015 system;
f) Field of view range;
g) Quality control methods (including at least self-calibration methods), frequency and tools used;
Note. The quality control content of factors affecting the positioning accuracy (see Appendix A) other than the optical positioning equipment of the body surface is not within the scope of this standard.
h) Typical test conditions for setup correction (including but not limited to. CT plan image scanning conditions, reference images, image reconstruction algorithms, graphs
Like registration algorithms, etc.);
Note. Typical test conditions are a set of test conditions commonly used in clinical practice.
i) If a marker is used, it should indicate its possible impact on the therapeutic radiation;
j) Equipment warm-up (stabilization) time;
k) The basic parameters of the light source used;
l) The installation requirements of the optical positioning equipment on the body surface, that is, the distance between the reference point of the optical positioning equipment on the body surface and the center or reference point of the treatment equipment
Installation deviation requirements;
m) The refresh frequency of the optical positioning device on the body surface.
4.2 Field of view range
The medical device product technical requirements shall specify the field of view of the body surface optical positioning equipment in the X, Y, and Z directions.
4.3 Positioning accuracy
Under the typical test conditions specified by the manufacturer, using a static simulation model, the positioning accuracy should meet the following requirements.
a) The deviation between the center point position calculated by the positioning and its actual position is not more than 1.0mm;
b) The deviation between the positions of other points (except the center point) calculated by the positioning and their actual positions is not more than 1.5mm.
4.4 Repeatability of positioning
Within 25mm from the isocenter (or treatment reference point), under the typical test conditions specified by the manufacturer, the set-up repeatability should not be large
At 0.5mm.
4.5 System data refresh frequency
Under the typical test conditions specified by the manufacturer, the system data refresh frequency should not be less than 10Hz, that is, the data refresh delay should not be greater than
100ms.
4.6 Drift
Within 8 hours after the body surface optical positioning device reaches the specified system warm-up (stabilization) time, the position deviation caused by drift does not exceed
0.5mm.
4.7 Device function
The equipment should have at least the following functions.
a) Preheating interlock
The body surface optical positioning equipment should have a preheating interlock function, and it should not be performed before the specified system preheating (stabilization) time is reached
Set up work.
b) Patient data management
It should be able to manage patient data, and the data should at least include. patient personal information, plan information, body surface positioning marks and positioning reference
Point relationship, treatment progress.
c) Positioning and monitoring
Should have the following functions.
1) Collect and store body table information;
2) Record the positioning deviation during the treatment.
d) Data report output
It should be able to output data and generate documentation.
5 Test method
5.1 Random files
Check the random documents, which should meet the requirements of 4.1.
5.2 Field of view range
Place the markers in accordance with the manufacturer's regulations, move the markers in 2 directions along the X axis, and use the body surface optical positioning device to continue
Record the coordinates of the markers, find the coordinates of the two farthest markers in the X-axis direction, and then use this method to find the coordinates of the Y-axis and Z-axis.
The coordinates of the two farthest markers in the direction.
According to the coordinates of the two farthest markers in the X-axis, Y-axis, and Z-axis directions, the field of view range of the optical positioning device on the body surface should be obtained.
Meet the requirements of 4.2.
5.3 Positioning accuracy
5.3.1 Test phantom
a) Basic requirements
The following conditions should be met.
1) Due to the different marking and identification technologies used by the optical positioning equipment on the body surface, this test allows the use of different types of phantoms,
The selection of the true model should meet the requirements of this test verification.
2) The simulation model should at least have the corresponding body surface structure in order to be able to simulate the use of clinical body surface optical positioning equipment.
5.3.2 Test method
Under the typical test conditions specified by the manufacturer, perform the test according to the following steps.
a) Fix the simulation model on the CT table and scan according to the typical scanning conditions specified by the manufacturer of the optical positioning equipment on the body surface.
Acquire CT images.
Note. d is 15mm.
5.4 Repeatability of positioning
5.4.1 Test phantom
Same as 5.3.1.
5.4.2 Test method
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, perform the test according to the following steps.
a) Use body surface optical positioning equipment to collect 1min position coordinate data in real time, and save the collection results (including time Ti and position Pi).
b) Calculate the time difference between the adjacent position data Pi and Pi-1 in the collection result
c) The maximum value of ΔTi should meet the requirements of 4.5.
5.6 Drift
Fix a mark in the monitoring range of the body surface optical positioning device. After the system is turned on, the mark position is determined and recorded every minute.
A system drift curve is formed, and the elapsed time from the start to the stable mark position is the start time.
5.7 Device function
The actual operation verification shall meet the requirements of 4.7.
Appendix A
(Informative appendix)
Application Note of Body Surface Optical Positioning Equipment
Positioning technology is an extremely important link in the process of radiotherapy. Its purpose is to reproduce the posture during simulated positioning, in order to achieve rehabilitation.
The target area determined during the planning design, the essence of using the body surface optical positioning equipment for radiotherapy positioning is to start from the radiotherapy planning system
The body surface morphology extracted in the (TPS) image is used as a reference standard, and the patient body surface morphology obtained in real time during actual positioning is compared.
Consistent registration is to determine the center position of the patient's tumor in the radiotherapy planning system (TPS), and move the patient support device (such as treatment
Bed), which coincides with the center (or treatment reference point) of the external irradiation equipment (such as accelerator), so that the radiation dose is in accordance with the designed radiation treatment
The treatment plan is accurately delivered to the tumor target area.
Different forms of body surface optical positioning equipment, the main difference is that the acquired morphological information is different (such as. infrared reflective point imaging, structure
Surface imaging of light-constituting, etc.). There are two main types of registration. One is to visualize feature points in the radiotherapy planning system (TPS).
The body surface optical positioning equipment can detect the corresponding feature points, so as to perform "point-to-point" registration; the other is to obtain the body surface in the image
Face shape, when positioning, the body surface optical positioning device can detect the corresponding face shape, so as to perform "face-to-face" registration.
In the process of radiotherapy, there are many errors due to equipment reasons, such as the positioning error of the optical positioning equipment of the body surface, the external illumination
There are errors in the center of the radiography equipment itself, the laser light in the treatment room, and the position of the patient support device. If it is not corrected in time,
Yes, these errors will accompany the radiotherapy process all the time, leading to inaccurate target doses. Therefore, in order to improve the quality of radiotherapy, in addition to controlling
The positioning accuracy of the optical positioning equipment on the body surface should be prepared, and the mechanical and geometric parameters of the external exposure equipment should be regularly checked, such as external exposure equipment.
The calibration of the preparation center, the calibration of the laser light in the treatment room, the position correction of the patient support device, etc., minimize the positioning error to ensure
Prove the accuracy of each radiotherapy setting, so that the entire treatment plan can be executed correctly, and ensure that the delivery of radiotherapy dose
Meet the requirements of clinical treatment.