YY/T 1694-2020Optical positioning device for radiation therapy—Performance and test methods (English PDF)
放射治疗用体表光学摆位设备 性能和试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
February 21, 2020
Implementation date
June 1, 2021
Scope
YY/T 1694-2020 is the English-translated version of 放射治疗用体表光学摆位设备 性能和试验方法.
YY/T 1694-2020 is the Chinese pharmaceutical industry standard for the optical positioning device used in radiotherapy, the laser and light field system by which the patient is set up on the treatment couch.
It specifies the performance requirements and the test methods, covering the coincidence of the light and radiation fields, the accuracy and straightness of the laser lines and their coincidence with the isocentre, the stability of the alignment over time and the safety of the light sources. It was issued on 21 February 2020 and has applied since 1 June 2021.
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Document preview — YY/T 1694-2020
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 Terms and definitions4
- 4 Requirements4
- 4.1 Accompanying documents4
- 4.2 Field of view5
- 4.3 Positioning accuracy6
- 4.4 Position repeatability6
- 4.5 System data refresh frequency6
- 4.6 Drift6
- 4.7 Equipment functions6
- 5 Test method7
- 5.1 Accompanying documents7
- 5.2 Field of view7
- 5.3 Positioning accuracy7
- 5.4 Positioning repeatability9
- 5.5 System data refresh frequency10
- 5.6 Drift10
- 5.7 Device functions10
- Appendix A (Informative) Application descriptions for optical positioning device11
Foreword
This standard was drafted in accordance with the rules given in GB/T1.1-2009.
1 Scope
This standard specifies the performance and test methods of optical positioning device for radiation therapy.
This standard applies to the optical positioning device for radiation therapy, by optical methods (including visible light, infrared light, laser, etc.).
2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this standard.
GB/T 18987-2015 Radiotherapy equipment - Coordinates, movements and scales
3 Terms and definitions
The following terms and definitions apply to this document.
4 Requirements
4.1 Accompanying documents
Accompanying documents shall contain the following.
4.2 Field of view
The technical requirements for medical device products shall specify the field of view of the optical positioning device in the three directions of X, Y, Z.
4.3 Positioning accuracy
Under the typical test conditions specified by the manufacturer, using a static simulation model, the positioning accuracy shall meet the following requirements.
4.4 Position repeatability
Within the range of 25 mm from the isocenter (or treatment reference point), under the typical test conditions specified by the manufacturer, the positioning repeatability shall not be greater than 0.5 mm.
4.7 Equipment functions
The equipment shall at least have the following functions.
5 Test method
5.1 Accompanying documents
Check the accompanying documents, which shall meet the requirements of 4.1.
5.2 Field of view
Place the markers, according to the manufacturer's requirements. Move the markers along the two directions of the X-axis.
5.3 Positioning accuracy
5.3.2 Test method
Under the typical test conditions specified by the manufacturer, to carry out the test, in accordance with the following steps.
5.4 Positioning repeatability
5.4.1 Test phantom
Same as 5.3.1.
5.5 System data refresh frequency
5.5.1 Test phantom
Same as 5.3.1.
5.5.2 Test procedure
Under the typical test conditions specified by the manufacturer, the test is carried out in accordance with the following steps.
5.6 Drift
A mark is fixed within the monitoring range of the optical positioning device. After the system is turned on, the mark position is determined and recorded once every minute, to generate the system drift curve. The time elapsed from the start-up to the stable mark position is the start-up time.
Appendix A (Informative)
Application descriptions for optical positioning device Positioning technology is an extremely important link in the process of radiation therapy.
Its purpose is to reproduce the body position during simulation positioning, in order to achieve the target area, which is determined during the design of the reproduction plan.
The nature of the use of optical positioning device for radiotherapy positioning is using body surface morphology, which is extracted from the images of the radiation therapy planning system (TPS), as a reference standard, to perform consistent registration with the patient's body surface shape, which is obtained in real time during the actual positioning. The position of the patient's tumor center, which is determined in the system (TPS), coincides with the isocenter (or treatment reference point) of the external radiation equipment (such as an accelerator), by moving the patient support device (such as a treatment bed), so that the radiation dose can be precisely delivered to the tumor target area, according to the designed radiation therapy plan.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
GB/T 18987-2015 — Radiotherapy equipment -- Coordinates, movements and scales
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
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