YY/T 1694-2020 PDF English
US$145.00 · In stock · Download in 9 secondsYY/T 1694-2020: Optical positioning device for radiation therapy - Performance and test methods Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1694-2020 | English | 145 |
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Optical positioning device for radiation therapy - Performance and test methods
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YY/T 1694-2020: Optical positioning device for radiation therapy - Performance 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/YYT1694-2020
YY
PHARMACEUTICALS INDUSTRY STANDARD
ICS 11.040.60
C 43
Optical positioning device for radiation therapy –
Performance and test methods
Issued on. FEBRUARY 21, 2020
Implemented on. JUNE 01, 2021
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Requirements... 4
4.1 Accompanying documents... 4
4.2 Field of view... 5
4.3 Positioning accuracy... 6
4.4 Position repeatability... 6
4.5 System data refresh frequency... 6
4.6 Drift... 6
4.7 Equipment functions... 6
5 Test method... 7
5.1 Accompanying documents... 7
5.2 Field of view... 7
5.3 Positioning accuracy... 7
5.4 Positioning repeatability... 9
5.5 System data refresh frequency... 10
5.6 Drift... 10
5.7 Device functions... 10
Appendix A (Informative) Application descriptions for optical positioning device... 11
Foreword
This standard was drafted in accordance with the rules given in GB/T1.1-2009.
Please note that some contents of this document may refer to patents. The issuing
agency of this document assumes no responsibility for identifying these patents.
This standard was proposed by the National Medical Products Administration.
This standard shall be under the jurisdiction of the Radiotherapy, Nuclear Medicine and
Radiation Dosimetry Equipment Sub-Technical Committee of National Medical
Electrical Appliances Standardization Technical Committee (SAC/TC 10/SC 3).
Drafting organizations of this standard. Beijing Medical Device Inspection Institute,
Nanjing University, Beijing Huiren Haitai Innovative Medical Technology Service Co.,
Ltd., Jiangsu Ruier Medical Technology Co., Ltd.
The main drafters of this standard. Zheng Lifu, Ge Yun, Xie Bingbing, Wang Huiliang,
Fu Dongshan.
Optical positioning device for radiation therapy –
Performance and test methods
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
5.3.1 Test phantom
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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