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YY/T 1537-2017: Laser positioning system in radiation therapy - Functional-performance characteristics and test methods
YY/T 1537-2017
Laser positioning system in radiation therapy-Functional-performance characteristics and test methods
ICS 11.040.60
C43
People's Republic of China Pharmaceutical Industry Standard
Radiation therapy laser positioning system
Performance and test methods
Published by.2017-05-02
2018-04-01 implementation
State Food and Drug Administration issued
Content
Foreword I
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
4.1 Random File 1
4.2 Coordinate system 1
4.3 Radiation therapy laser positioning system laser classification 2
4.4 Radiation therapy laser positioning system positioning line width 2
4.5 Length of laser positioning line 2
4.6 Straightness of laser line 2
4.7 Verticality of the laser crosshair (if applicable) 2
4.8 Radiotherapy positioning laser system positioning accuracy 2
4.9 Mobile radiotherapy positioning laser system moving range 3
4.10 Software Features (if applicable) 3
4.11 MRI compatibility (if applicable) 3
5 Test method 3
5.1 Random File 3
5.2 coordinate system 3
5.3 Radiation therapy laser positioning system classification 3
5.4 Radiation therapy laser positioning system positioning line width 3
5.5 Laser line length 4
5.6 Straightness of the laser line 4
5.7 Verticality of the laser crosshair (if applicable) 4
5.8 Radiotherapy positioning laser system positioning accuracy 4
5.9 Mobile radiotherapy positioning laser system moving range 5
5.10 Radiation therapy positioning laser system positioning software 5
5.11 MRI compatibility (if applicable) 5
Appendix A (informative) Test phantom 6
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is divided into the Technical Committee of Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment of the National Medical Electrical Equipment Standardization Technical Committee.
(SAC/TC10/SC3) is under the jurisdiction.
This standard was drafted. Beijing Medical Device Inspection Institute, Beijing Zhongkanglian Medical Device Development Co., Ltd., Shanghai Jianchang Medical Devices
Ltd., LAP Laser Application Technology (Shanghai) Co., Ltd.
The main drafters of this standard. Chen Jing, Li Ming, Zhang Zhongzhu, Zou Cheng, Yan Fuqiang, Li Lizhen.
Radiation therapy laser positioning system
Performance and test methods
1 Scope
This standard specifies the performance and test methods of radiotherapy laser positioning systems.
This standard applies to different types of radiation therapy and positioning equipment (such as cobalt-60 teletherapy machine, medical electron accelerator, radiotherapy
External laser positioning system for use in therapy simulators, radiotherapy CT simulators, radiation therapy MRI simulators, etc.
Position reference marks are projected on the registration device such as the skin, the patient fixture, and the stereotactic frame, so that the patient can be treated during radiotherapy
Row positioning.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 7247.1-2012 Safety of laser products - Part 1. Equipment classification, requirements
GB 9706.5 Medical electrical equipment - Part 2. Safety requirements for 1 to 3 MeV to 50 MeV electron accelerators
GB/T 13739-2011 Laser beam width, divergence angle test method and transverse mode identification method
GB 15213 Medical Electron Accelerator Performance and Test Method
GB/T 17857 Medical radiology terms (radiation therapy, nuclear medicine and radiation dosimetry equipment)
3 Terms and definitions
The terms and definitions defined in GB 15213, GB 9706.5, GB/T 17857, and GB 7247.1 apply to this document.
4 requirements
4.1 Random files
At least the following should be included in the random file of the radiotherapy positioning laser system.
a) technical parameters of 4.2~4.9;
b) the type of laser;
c) laser color (wavelength);
d) the number of projection and movement methods, and the number of laser positioning lines;
e) the maximum output power of the laser;
f) moving speed;
g) Description of the System Quality Assurance (QA) verification function.
4.2 Coordinate system
The system should use a right-handed rectangular coordinate system. The straight line direction between the coordinate systems is shown in Figure 1.
Figure 1 Schematic diagram of the coordinate system of the radiotherapy laser positioning system
4.3 Radiation therapy laser positioning system laser classification
The classification of radiotherapy lasers should not be higher than the 2M class specified in GB 7247.1-2012.
4.4 Radiation therapy laser positioning system positioning line width
At a distance of 3 m from the laser emission window, the laser positioning line width should not exceed 1.0 mm.
4.5 Length of laser positioning line
At a distance of 3 m from the laser emission window, it should not be less than 1 m.
4.6 Straightness of the laser line
3m away from the laser emission window, the straightness should not exceed 0.5mm in the range of not less than 1m.
4.7 Verticality of the laser crosshair (if applicable)
At a distance of 3 m from the laser emission window, the perpendicularity of the laser projection cross positioning line should not be greater than 0.2 degrees.
4.8 Radiotherapy positioning laser system positioning accuracy
4.8.1 Consistency with reference points
The position of the laser positioning line should be adjustable. The deviation between the indicated position and the actual position of the reference point after adjustment should not exceed ±0.5mm.
4.8.2 Consistency with the reference plane (if applicable)
The following requirements should be met.
a) the plane formed by the laser positioning line should be able to identify the scanning plane (such as the imaging plane of the CT simulator);
b) The laser positioning system should be adjustable. After adjustment, the laser positioning line projected by each laser should be parallel or coincident with the reference plane or
vertical.
4.8.3 Mobile radiotherapy positioning laser system mobile positioning accuracy (if applicable)
4.8.3.1 Projection accuracy
When the laser positioning line moves in the movable direction, the maximum deviation between the actual arrival position of the laser line and the preset position should not exceed
±0.5mm.
4.8.3.2 Projective repeatability
When the laser light moves in the movable direction, the maximum deviation of the laser line from the actual position to the preset position should not exceed
±0.5mm.
4.9 Mobile radiation therapy positioning laser system moving range
The range of movement should not be less than 550mm.
4.10 Software Features (if applicable)
Should have at least the following functions.
a) can edit the patient's coordinate parameters;
b) can read the laser light coordinate file of various radiotherapy planning systems transmitted by DICOMRT;
c) can control the movable laser line to reach the specified position;
d) laser track verification function;
e) laser track return to zero function;
f) stop running;
g) Patient information management functions.
4.11 MRI compatibility (if applicable)
When used with MRI, the manufacturer should give an MRI compatibility statement in a random file.
5 Test methods
5.1 Random files
Access to random documents should meet the requirements of 4.1.
5.2 coordinate system
Access to random documents should meet the requirements of 4.2.
5.3 Classification of radiotherapy laser positioning systems
Testing according to the methods given in Chapters 8 and 9 of GB 7247.1-2012 shall comply with the requirements of 4.3.
5.4 Radiation therapy laser positioning system positioning line width
The test method is as follows.
a) Test environment. the ambient light level should be between 50lx and 500lx, and other test environmental conditions should meet the manufacturer's requirements;
b) measuring plane. 3m away from the laser emission window;
c) Method. Measure according to the density distribution method given in 5.1 of GB/T 13739-2011.
The measurement results should meet the requirements of 4.4.
5.5 Laser line length
3m away from the laser emission window, the laser light is directly irradiated on the plane, and the line length is measured by a universal measuring tool, which should meet the 4.5
Claim.
5.6 Straightness of the laser line
The test method specified in Method 1 or Method 2 can be selected for testing.
method 1.
a) Use a CCD detector to receive the positioning line from the laser, record the position of the peak, repeat sampling 10 times, and find the peak position flat.
Mean
b) Move the detector on a precision guide or other equivalent device, move the separation distance to 10 cm, repeat step a) until the distance is moved
Not less than 1m;
c) Fitting the data points to obtain a straight line, the maximum deviation of each point from the straight line should meet the requirements of 4.6.
Method 2. Fix the coordinate paper on a vertical surface, and the distance between the laser and the coordinate paper is 3m. Project the laser line onto the coordinate paper, at
Within 1m range, the degree of bending of the laser line on the coordinate paper shall meet the requirements of 4.6.
5.7 Verticality of the laser crosshair (if applicable)
The measurement of the verticality using a measuring tool at a distance of 3 m from the laser emission window shall comply with the requirements of 4.7.
5.8 Radiotherapy positioning laser system positioning accuracy
5.8.1 Consistency with reference points
The following tests can be performed using the phantom specified in Appendix A or according to the equivalent phantom provided by the manufacturer. The reference point can be selected as an isocenter or sweep.
Centering.
The specific method is as follows.
a) Equipment with isocenter. determine the isocenter position of the isocenter equipment, verify the consistency with the isocenter, and shall comply with 4.8.1
Requirements.
b) Equipment with a scanning center. Position the phantom so that it is placed in the center of the scan to align the laser line with the marker line. Choose appropriate
When the layer is thick, the scanning phantom acquires an image. Adjust the position of the phantom until the phantom line image appears at the center level. measuring
The distance between the center point and the scanning center (isocenter) shall comply with the requirements of 4.8.1.
5.8.2 Consistency with the reference plane
The following tests can be performed using the phantom specified in Appendix A or according to the equivalent phantom provided by the manufacturer.
a) Equipment with isocenter. use phantoms or related tools to determine consistency with the reference plane and shall comply with 4.8.2
Claim;
b) Equipment with scanning center. on the basis of 5.8.1, move the patient bed in the X, Y, Z direction to verify the projection line of each laser light
The conformity of the phantom marking line, measuring the distance between the two, shall comply with the requirements of 4.8.2.
5.8.3 Mobile radiotherapy positioning laser system mobile positioning accuracy (if applicable)
5.8.3.1 Projection accuracy
For each laser lamp, move ±100mm, ±200mm, ±300mm (or maximum moving distance) within the moving range, and measure
Move the distance, record the deviation between the measured value and the preset value, and take the average. Repeat 5 times, the maximum average should meet the requirements of 4.8.3.1.
5.8.3.2 Projective repeatability
Projection repeatability is represented by the range S. In the measurement of 5.8.3.1, select ±100mm, ±200mm, ±300mm from the center point
Any one of the moving distances (or the maximum moving distance), repeating the movement 10 times, recording the moving distance, and the range S is given by the formula (1).
S=Lmax-Lmin (1)
In the formula.
Lmax---the maximum measured value of the moving distance;
Lmin---Minimum distance measurement.
The range S should meet the requirements of 4.8.3.2.
5.9 Mobile radiation therapy positioning laser system moving range
Make the positioning laser light full stroke motion, test on the vertical plane 3m away from the positioning laser emission window, repeat 5 times, test
The full stroke movement range value, averaged, should meet the requirements of 4.9.
5.10 Radiation therapy positioning laser system positioning software
The actual operation confirms the software function and should meet the requirements of 4.10.
5.11 MRI compatibility (if applicable)
Access to random documents should meet the requirements of 4.11.
Appendix A
(informative appendix)
Test phantom
The following test phantoms are only an example, and other phantoms can be used to perform the same test.
The phantom includes a transparent synthetic resin base with three synthetic resin cuboid modules mounted on the base, each of which has a cross in the center
The air gap shows a crosshair after imaging. The schematic diagram of the mold is shown in Figure A.1.
a) schematic view of the mold body
b) schematic view of the phantom
Figure A.1 Schematic diagram of the mold