YY/T 1538-2017 English PDF (YYT1538-2017)

This standard specifies the functional-performance requirements and test methods for automatic scanning water phantom system for radiotherapy. The system, by moving the detector, realizes the automatic measurement of radiation dose distribution for radiotherapy.

YY/T 1538-2017
YY
PHARMACUETICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
C 43
Auto-scanning water phantom system in radiation therapy -
Functional-performance characteristics and test methods
ISSUED ON. MAY 2, 2017
IMPLEMENTED ON. APRIL 1, 2018
Issued by. China Food and Drug Administration
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Table of Contents
Foreword ... 3
1 Scope .. 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Requirements ... 5
4.1 Accompanying documents ... 5
4.2 Positioning accuracy ... 6
4.3 Positioning repeatability .. 6
4.4 Verticality of each axis.. 6
4.5 Sampling-point density ... 6
4.6 Requirements of radiation measurement unit ... 6
4.7 Software functions ... 7
5 Test methods .. 7
5.1 Accompanying documents ... 7
5.2 Positioning accuracy ... 7
5.3 Positioning repeatability .. 8
5.4 Verticality of each axis.. 8
5.5 Density of sampling point ... 8
5.6 Requirements of radiation measurement unit ... 9
5.7 Software function ... 9
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuer of this document shall not be held responsible for identifying any or all such patent rights.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee on Medical Electrical Appliances Standardization, Sub-technical Committee on Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment (SAC/TC 10/SC 3).
The drafting organizations of this Standard. Beijing Medical Device Testing Institute, China Institute of Metrology, Zhejiang Institute of Metrology, China Test Technology Research Institute, Shanghai Lianying Medical Technology Co., Ltd., PLA General Hospital of Beijing Military Region, Chinese Academy of Medical Sciences Cancer Hospital.
The main drafters of this Standard. Zhang Xin, Zhang Hui, Chen Can, Huang Yang, Li Gui, Zhang Fuli, Miao Junjie.
Auto-scanning water phantom system in radiation therapy -
Functional-performance characteristics and test methods
1 Scope
This standard specifies the functional-performance requirements and test methods for automatic scanning water phantom system for radiotherapy. The system, by moving the detector, realizes the automatic measurement of radiation dose distribution for radiotherapy.
This standard applies only to one-dimensional, two-dimensional, three-dimensional auto-scanning water phantom system for radiotherapy.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition dated applies to this document. For undated references, the latest edition of the referenced documents (including all amendments) applies to This Standard.
GB/T 17857, Medical radiology - Terminology (Equipment for radiotherapy, nuclear medicine and radiation dosimetry)
YY/T 0976-2016, Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
3 Terms and Definitions
Those defined in GB/T 17857 and YY/T 0976-2016 AND the following terms and definitions apply to this document.
3.1 Automatic scanning water phantom system
Automatic scanning water phantom system (also known as scanning water tank, hereinafter referred to as the system) is an ionizing radiation measuring system in the field of radiation therapy, which automatically measures the radiation dose distribution by moving the detector.
NOTE 1. By measuring, the system automatically provides the characteristic data of the radiation beam, such as PDD, OAR, TPR, penumbra, symmetry, flatness, maximum dose point depth.
c) calculate the average of measurement deviation of each position. It shall meet the requirements of 4.2.
d) for other axes of the system, repeat the test described in a) ~ d). The result shall meet the requirements of 4.2.
5.3 Positioning repeatability
When the system works under normal use-conditions, follow the methods below. Manipulate the moving components in each direction; move to the following specified positions.
a) (0, 0, 0) to (0, 0, 100mm);
b) (0, 0, 0) to (0, 100mm, 0);
c) (0, 0, 0) to (100mm, 0, 0);
d) (0, 0, 0) to (200mm, 200mm, 100mm).
Each time, after completing above motions and returning to the initial point, measure the actual position of detector. The maximum deviation of the actual position of all 10 motions at all measurement points of each axis shall meet the requirements of 4.3. 5.4 Verticality of each axis
When the system works under normal use-conditions, follow the methods below. Manipulate the moving components in each direction; move to the following specified positions.
a) (0, 0, 0) to (0, 0, 100mm);
b) (0, 0, 0) to (0, 100mm, 0);
c) (0, 0, 0) to (100mm, 0, 0);
d) (0, 0, 0) to (200mm, 200mm, 100mm).
Each time, after completing above motions and returning to the initial point, in the travel-range, measure the displacement between the moving direction axis and each axis’ reference straight-line. It shall meet the requirements of 4.4.
5.5 Density of sampling point
Start automatic scanning water phantom system for radiotherapy; for function checking, it shall meet the requirements of 4.5.