YY 1650-2019X-ray based image-guided radiotherapy equipment - Performance characteristics and test methods (English PDF)
X射线图像引导放射治疗设备性能和试验方法
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
May 31, 2019
Implementation date
December 1, 2020
Scope
YY 1650-2019 is the English-translated version of X射线图像引导放射治疗设备性能和试验方法.
YY 1650-2019 is the Chinese standard "X-ray based image-guided radiotherapy equipment - Performance characteristics and test methods". Its scope clause reads: This standard specifies the requirements and test methods for X-ray image guided radiotherapy (hereinafter referred to as X-IGRT) equipment.
This standard applies to electronic accelerators, light ion beam therapy equipment and X-IGRT equipment for radionuclide beam therapy equipment. Its clauses include terms and definitions.
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Document preview — YY 1650-2019
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C43
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
- 4.1 Random File
- 4.2 X-IGRT equipment radiation field size
- 4.3 Target guidance range of X-IGRT equipment
- 4.4 Image quality of X-IGRT equipment
- 4.5 imaging dose
- 4.6 Accuracy of X-IGRT Position Correction Calculation
- 4.7 Repeatability of X-IGRT Position Correction Calculation
- 4.8 Influence of reference image layer thickness on X-IGRT position correction calculation
- 4.9 Influence of reference image DRR algorithm on X-IGRT position correction calculation
- 4.10 Effect of radiation quality on X-IGRT position correction calculation
- 4.11 Influence of X-IGRT reconstruction algorithm on X-IGRT position correction calculation
- 4.12 Effect of Image Registration Algorithm on X-IGRT Position Correction Calculation
- 5 Test method
- 5.1 Random File
- 5.2 X-IGRT equipment radiation field size
- 5.3 Target guidance range of X-IGRT equipment
- 5.4 Image quality of X-IGRT equipment
- 5.5 imaging dose
- 5.6 Accuracy of X-IGRT Position Correction Calculation
- 5.7 Repeatability of X-IGRT Position Correction Calculations
- 5.8 Influence of reference image layer thickness on X-IGRT position correction calculation
- 5.9 Influence of reference image DRR algorithm on X-IGRT placement correction calculation
- 5.10 Effect of radiation quality on X-IGRT position correction calculation
- 5.11 Effect of X-IGRT image reconstruction algorithm on X-IGRT placement correction calculation
- 5.12 Effect of Image Registration Algorithm on X-IGRT Position Correction Calculation
1 Scope
This standard specifies the requirements and test methods for X-ray image guided radiotherapy (hereinafter referred to as X-IGRT) equipment.
This standard applies to electronic accelerators, light ion beam therapy equipment and X-IGRT equipment for radionuclide beam therapy equipment.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 15213-2016 Medical electron accelerator performance and test methods
IEC 60601-2-68.2014 Medical electrical equipment - Part 2-68. Electron accelerators, light ion beam therapy equipment and radiation
Special requirements for basic safety and basic performance of X-ray image-guided radiotherapy equipment for use with sex nuclear beam therapy equipment
3 Terms and definitions
The following terms and definitions defined in GB 15213-2016 and IEC 60601-2-68.2014 apply to this document.
3.1 Image guided radiotherapy
IGRT A radiation therapy process. An image of the target area and its surrounding anatomy at the time of treatment to determine the therapeutic beam in the patient relative to
The position of the target zone is predetermined to make the necessary corrections to the predetermined position of the beam relative to the target zone.
[GB 15213-2016, definition 3.8]
3.2 Image reconstruction
A method of processing the acquired data into an image data set that can be used for analysis.
[IEC 60601-2-68.2014, definition.2011.3.210]
3.3 Image registration
A method of mapping or mapping a point in a set of image data sets with a corresponding point in another set of image data sets.
[IEC 60601-2-68.2014, definition.2011.3.211]
3.4 KV X-IGRT device kilovoltageX-IGRTequipment
X-IGRT equipment using kV X radiation.
[IEC 60601-2-68.2014, definition.201.3.213]
3.5 Megavolt X-IGRT device megavoltageX-IGRTequipment
X-IGRT equipment using megavolt X radiation. […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 13 pages — is available in the English PDF.
Referenced standards
Normative references
IEC 60601
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