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YY/T 1537-2017 (YYT 1537-2017)

YY/T 1537-2017_English: PDF (YYT1537-2017)
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YY/T 1537-2017English145 Add to Cart 0--3 minutes. Auto-delivered. Laser positioning system in radiation therapy—Functional-performance characteristics and test methods YY/T 1537-2017 Valid YY/T 1537-2017

BASIC DATA
Standard ID YY/T 1537-2017 (YY/T1537-2017)
Description (Translated English) Laser positioning system in radiation therapy--Functional-performance characteristics and test methods
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.60
Word Count Estimation 9,958
Date of Issue 2017-05-02
Date of Implementation 2018-04-01
Drafting Organization Beijing Medical Device Testing Institute, Beijing Kanglian Medical Devices Development Co., Ltd., Shanghai Jianchang Medical Devices Co., Ltd., Radar Laser Application Technology (Shanghai) Co., Ltd.
Administrative Organization National Technical Committee for Medical Appliance Standardization Technical Committee on Radiation Therapy, Nuclear Medicine and Radiological Equipment (SAC/TC 10/SC 3)
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 49
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 1537-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
C 43
Laser positioning system in radiation therapy -
Functional-performance characteristics and test methods
ISSUED ON. MAY 02, 2017
IMPLEMENTED ON. APRIL 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 4 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 6 
4 Requirements ... 6 
4.1 Accompanying documents ... 6 
4.2 Coordinate system ... 6 
4.3 Laser classification of laser positioning system in radiation therapy ... 7 
4.4 Positioning-line width of laser positioning system in radiation therapy ... 7 
4.5 Length of laser positioning-line ... 7 
4.6 Straightness of laser line ... 7 
4.7 Verticality of laser cross positioning-line (if applicable) ... 7 
4.8 Positioning accuracy of laser positioning system in radiation therapy ... 7 
4.9 Moving range of laser positioning system in mobile radiation therapy ... 8 
4.10 Software functions (if applicable) ... 8 
4.11 MRI compatibility (if applicable) ... 8 
5 Test methods ... 8 
5.1 Accompanying documents ... 8 
5.2 Coordinate system ... 8 
5.3 Classification of laser positioning system in radiation therapy ... 9 
5.4 Positioning-line width of laser positioning system in radiation therapy ... 9 
5.5 Length of laser line ... 9 
5.6 Straightness of laser line ... 9 
5.7 Verticality of laser cross positioning-line (if applicable) ... 10 
5.8 Positioning accuracy of laser positioning system in radiation therapy ... 10 
5.9 Moving range of laser positioning system in mobile radiation therapy ... 11 
5.10 Positioning software of laser positioning system in radiation therapy ... 11 
5.11 MRI compatibility (if applicable) ... 11 
Appendix A (Informative) Test phantom ... 12 
Laser positioning system in radiation therapy -
Functional-performance characteristics and test methods
1 Scope
This Standard specifies functional-performance characteristics and test
methods for laser positioning system in radiation therapy.
This Standard is applicable to the matched external laser positioning systems
used in different types of radiation therapy and positioning equipment (such as
cobalt-60 teletherapy machine, medical electron accelerator, radiation therapy
simulator, radiation therapy CT simulator, radiation therapy MRI simulator, etc.),
which are used to project a positional reference mark on the patient’s skin, the
patient fixing device, the stereotactic frame, and other registration devices, to
position the patient during radiation therapy.
2 Normative references
The following documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are
applicable to this document. For the undated references, the latest edition
(including all the amendments) are applicable to this document.
GB 7247.1-2012 Safety of laser products - Part 1. Equipment classification
and requirements
GB 9706.5 Medical electrical equipment - Part 2-1. Particular requirements
for the safety of electron accelerators in the range 1 MeV to 50 MeV
GB/T 13739-2011 Test methods for laser beam widths, divergence angle and
transverse mode
GB 15213 Medical electron accelerators - Functional performance
characteristics and test methods
GB/T 17857 Medical radiology - Terminology (Equipment for radiotherapy,
nuclear medicine and radiation dosimetry)
4.3 Laser classification of laser positioning system in radiation therapy
The classification of radiation therapy laser shall not be higher than the 2 M
category specified in GB 7247.1-2012.
4.4 Positioning-line width of laser positioning system in radiation therapy
At a distance of 3 m from the laser emitting window, the laser positioning-line
width shall not exceed 1.0 mm.
4.5 Length of laser positioning-line
At a distance of 3 m from the laser emitting window, it shall not be less than 1
m.
4.6 Straightness of laser line
At a distance of 3 m from the laser emitting window, within a range of not less
than 1 m, the straightness shall not exceed 0.5 mm.
4.7 Verticality of laser cross positioning-line (if applicable)
At a distance of 3 m from the laser emitting window, the verticality of laser
projection cross positioning-line shall not be greater than 0.2 degrees.
4.8 Positioning accuracy of laser positioning system in radiation therapy
4.8.1 Consistency with reference point
The position of laser positioning-line shall be adjustable. After adjusting, the
deviation between the indication position and the actual position of reference
point shall not exceed ±0.5 mm.
4.8.2 Consistency with reference plane (if applicable)
The following requirements shall be met.
a) The plane formed by laser positioning-line shall be able to identify the
scanning plane (such as the imaging plane of CT simulator);
b) The laser positioning system shall be adjustable. After adjusting, the laser
positioning-line projected by each laser lamp shall be parallel or coincident
or perpendicular to the reference plane.
4.8.3 Mobile positioning accuracy of laser positioning system in mobile
radiation therapy (if applicable)
4.8.3.1 Projection accuracy
5.3 Classification of laser positioning system in radiation therapy
TEST according to the methods given in Clause 8 and Clause 9 of GB 7247.1-
2012. It shall meet the requirements of 4.3.
5.4 Positioning-line width of laser positioning system in radiation therapy
The test method is as follows.
a) Test environment. Ambient illumination shall be between 50 lx~500 lx.
Other test environmental conditions shall meet the manufacturer’s
requirements;
b) Measuring plane. 3 m away from the laser emitting window;
c) Method. MEASURE according to the density distribution method given in
5.1 of GB/T 13739-2011.
The measurement result shall meet the requirements of 4.4.
5.5 Length of laser line
At a distance of 3 m from the laser emitting window, MAKE the laser light directly
irradiated on the plane; USE a universal measuring tool to measure the line
length. It shall meet the requirements of 4.5.
5.6 Straightness of 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 value; REPEAT sampling 10 times;
and OBTAIN the average of the peak position;
b) On a precision guide rail or other equivalent devices, MOVE the
detector. The moving spacing distance is 10 cm. REPEAT Step a), until
the moving distance is not less than 1 m;
c) FIT the data points to obtain a straight line. The maximum deviation of
each point from the straight line shall meet the requirements of 4.6.
Method 2. The coordinate paper is fixed on a vertical surface. The distance
between the laser and the coordinate paper is 3 m. The laser line is projected
onto the coordinate paper. Within a range of 1 m, on the coordinate paper,
the degree of bending of laser line is measured. It shall meet the