YY/T 1538-2017 (YY/T1538-2017, YYT 1538-2017, YYT1538-2017) & related versions
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Auto-scanning water phantom system in radiation therapy—Functional-performance characteristics and test methods
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YY/T 1538-2017
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YYT 1538-2017
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YY/T 1538-2017: PDF in English (YYT 1538-2017)
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
3. No action is required - Full-copy of this standard will be automatically &
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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.
......
| Standard ID | YY/T 1538-2017 (YY/T1538-2017) | | Description (Translated English) | Auto-scanning water phantom 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 | 7,769 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Beijing Institute of Medical Device Inspection, China Institute of Metrology, Zhejiang Institute of Metrology, China Test Technology Research Institute, Shanghai Liangying Medical Technology Co., Ltd., Beijing Military Region General Hospital of Chinese People's Liberation Army, Chinese Academy of Medical Sciences Cancer Hospital | | 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 |
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