YY/T 0890-2013 PDF English
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Electronic portal imaging device using in radiotherapy - Functional performance characteristics and test methods
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YY/T 0890-2013: Electronic portal imaging device using in radiotherapy - Functional performance characteristics and test methods
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0890-2013
YY
ICS 11.040.60
C 43
PHARMACEUTICAL INDUSTRY STANDARD
Electronic portal imaging device using in radiotherapy
– Functional performance characteristics and test
methods
Issued on. OCTOBER 21, 2013
Implemented on. OCTOBER 1, 2014
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Definitions... 4
4 Requirements... 5
5 Test methods... 8
Foreword
This Standard was drafted in accordance with the provisions given in the GB/T
1.1-2009.
Please pay attention that some contents in this Standard may involve patents.
The issuing authority of this Standard does not undertake the responsibility for
the identification of these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of the Technical Sub-committee of
the Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry of
the National Technical Committee for Standardization of Medical Electrical
Equipment (SAC/TC 10/SC 3).
Drafting organizations of this Standard. Beijing Institute of Medical Device
Testing, and Elekta BMEI (Beijing) Medical Equipment Co., Ltd.
Main drafters of this Standard. Feng Jian, Wang Peichen, Wang Huiliang, and
Jiao Chunying.
Electronic portal imaging device using in radiotherapy
– Functional performance characteristics and test
methods
1 Scope
This Standard specifies the performance requirements and test methods for the
electronic portal imaging devices.
This Standard applies to the electronic portal imaging devices using the
radiation beams of medical electron accelerators as radiation source in
radiotherapy.
2 Normative references
The following documents are essential to the application of this document. For
dated references, only the versions with the dates indicated are applicable to
this document. For undated references, only the latest versions (including all
the amendments) are applicable to this document.
GB/T 17857 Medical radiology – Terminology (Equipment for radiotherapy,
nuclear medicine and radiation dosimetry)
GB/T 18987 Radiotherapy equipment – Coordinates, movements and scales
3 Definitions
The terms and definitions defined in the GB/T 17857 and the following ones
apply to this document.
3.1 Electronic imaging device; EID
It refers to the equipment that is composed of one or more radiation detector(s)
and relevant electronic components, which can display the anatomical
structures of patients in the form of digital radiation images on the viewing
screen for observation.
Note. SEE also 3.2 of this edition.
3.2 Electronic portal imaging device; EPID
It refers to the equipment that is composed of one two-dimensional radiation
detector and relevant electronic components, and using the radiation beams of
the medical electron accelerator as radiation source, which is placed
perpendicular to the radiation beam axis, and can display the anatomical
structures of patients in the form of digital radiation images on the viewing
screen for observation.
3.4 Spatial resolution
It refers to the line pair groups with minimum spatial frequency for the specified
line groups of graphic images that can be distinguished by means of eyesight
under specified measuring conditions, in unit of lp/mm.
4 Requirements
4.1 General requirements
If the parameters and/or conditions of the electronic imaging device may not
apply to or cannot meet the requirements specified in this chapter, the
accompanying files shall describe these exceptions in details, and shall explain
the parameters and/or conditions applicable to this electronic imaging device.
4.3 Requirements for imaging performance
4.3.1 Detector area and pixel pitch
The detector area and pixel pitch of the electronic portal imaging device shall
be given in the accompanying files. The detector area shall be given in unit of
cm2, while the pixel pitch shall be given in unit of mm. Furthermore, the pixel
pitch can also be represented by pixel size.
4.3.4 Detector frame time
The minimum frame time corresponding to the maximum frame frequency
(frames/s) shall be given in the accompanying files. The minimum frame time
of the detector shall not be greater than 0.5s, while the corresponding maximum
frame frequency shall not be less than 2 frames/s.
4.3.5 Signal-to-noise ratio (SNR) and dynamic scope of imaging device
4.3.5.1 The signal-to-noise ratio corresponding to the dose shall be given in
the accompanying files, and shall be expressed as percentage or decibels. The
dynamic scope shall be given in unit of decibel.
4.3.5.2 For the dose of 1cGy, the signal-to-noise ratio shall not be less than
5,000%.
4.3.8 Spatial resolution of imaging devices
For a given set of imaging conditions (energy, dose monitoring count, and
detector frames), when imaging a phantom with a contrast test card located on
the EID surface, the distinguishable modulation transfer function (MTF) of the
maximum spatial frequency function shall be given in the accompanying files
by manufacturers.
4.3.9 Low contrast resolution
The low contrast resolution shall be given in the accompanying files by
manufacturers, and shall not be less than the numerical value specified by
manufacturers.
4.3.10 Image distortion
The image distortion shall be specified in the accompanying files by
manufacturers, and shall not be less than the numerical value specified by
manufacturers.
5 Test methods
5.1 Test conditions
The required parameters of image acquisition are interrelated, which shall be
given together. If it is allowed to adjust the relevance to these parameters for
the design of electronic imaging devices, the following 4 parameters shall be
repeatedly combined with each other to achieve various kinds of typical settings.
5.2 Mechanical support structure
5.2.1 CHECK the accompanying files and the scope of mechanical movement
for radiation field devices, which shall conform to the requirements given in the
accompanying files.
5.3 Electronic portal imaging
5.3.1 Detector area and pixel pitch
CHECK the accompanying files, which shall conform to the requirements
specified in the Article 4.3.1.
5.3.2 Detector characteristics
CHECK the accompanying files, which shall conform to the requirements
specified in the Article 4.3.2.
5.3.3 Number of visible pixels
CHECK the accompanying files, which shall conform to the requirements
specified in the Article 4.3.3.
5.3.7 Linearity of imaging devices
5.3.7.1 Aluminum ladder or copper ladder method
5.3.7.1.1 Phantom
The phantom consists of aluminum ladder or copper ladder. The phantom with
maximum thickness shall absorb more high-energy photons than the water with
30cm thickness. The gray-scale difference corresponding to the thickness of
each ladder shall be equal. The ladder grade shall not be less than Grade 5.
5.3.8 Spatial resolution of imaging devices
PLACE the line-pair phantom at the center of radiation beams. The phantom
shall be close to the image receiving surface as far as possible. OBTAIN the
images.
5.3.9 Low contrast resolution
5.3.9.1 Phantom
The low-contrast phantoms are obtained by digging holes with the diameter of
0.5mm to 15mm on the aluminum or copper products with certain thickness.
The hole depth shall be proportional to the material thickness.
5.3.9.2 Test methods
PLACE the low-contrast phantom at the center of radiation beams. The
phantom shall be close to the image receiving surface as far as possible.
OBTAIN the images.
5.3.10 Image distortion
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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