YY/T 0890-2013Electronic portal imaging device using in radiotherapy—Functional performance characteristics and test methods (English PDF)
放射治疗中电子射野成像装置性能和试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY/T 0890-2013 is the English-translated version of 放射治疗中电子射野成像装置性能和试验方法.
YY/T 0890-2013 is the Chinese pharmaceutical industry standard for the electronic portal imaging device used in radiotherapy.
It specifies the functional performance characteristics and the test methods, covering the image quality in terms of contrast, resolution and noise, the dose needed to form an image, the geometric accuracy of the image and its registration with the treatment field, the stability of the detector and the safety of its mounting and movement. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY/T 0890-2013
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Definitions4
- 4 Requirements5
- 5 Test methods8
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.
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
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
GB/T 17857-1999 — Medical radiology. Terminology (Equipment for radiotherapy, nuclear medicine and radiation dosimetry)
GB/T 18987-2015 — Radiotherapy equipment -- Coordinates, movements and scales
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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