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YY/T 1869-2023: (Detector array dosimetry system performance and test methods)
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| YY/T 1869-2023 | English | 169 |
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(Detector array dosimetry system performance and test methods)
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YY/T 1869-2023
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Basic data | Standard ID | YY/T 1869-2023 (YY/T1869-2023) | | Description (Translated English) | (Detector array dosimetry system performance and test methods) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 8,864 | | Date of Issue | 2023-01-13 | | Date of Implementation | 2024-07-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the performance and test methods of the detector array dose measurement system. This standard applies to detector array dosimetry systems, including detector arrays and supporting measurement software and result analysis software. | YY/T 1869-2023: (Detector array dosimetry system performance and test methods)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.50
CCSC43
Pharmaceutical Industry Standard of the People's Republic of China
Performance and Test Method of Detector Array Dosimetry System
Released on 2023-01-13
2024-07-15 Implementation
Released by the State Drug Administration
table of contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
4.1 Random file 1
4.2 Detector Array 2
4.3 Accuracy of dose distribution comparisons2
4.4 Instruction 2
4.5 Software functions 3
4.6 Dose reconstruction accuracy3
5 Test method 3
5.1 Random file 3
5.2 Detector Array 3
5.3 Accuracy of dose distribution comparisons4
5.4 Indication 4
5.5 Software functions 4
5.6 Dose reconstruction accuracy4
Reference 5
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is prepared by the National Medical Electrical Appliances Standardization Technical Committee Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment Standardization Sub-Technical Committee
Meeting (SAC/TC10/SC3) centralized.
This document was drafted by. Beijing Institute of Medical Device Testing, Peking University Third Hospital, Pedway Radiation Measuring Instruments (Beijing) Co., Ltd.
Co., Ltd., Yibia (Beijing) Particle Accelerator Technology Co., Ltd., Varian Medical Devices Trading (Beijing) Co., Ltd.
The main drafters of this document. Fu Guotao, Yang Ruijie, Jiao Chunying, Liu Di, Xu Lin, Wang Shun, Zhang Xin.
Performance and Test Method of Detector Array Dosimetry System
1 Scope
This document specifies the performance and test methods of the detector array dosimetry system (hereinafter referred to as the array system).
This document is applicable to the detector array dosimetry system, including the detector array and supporting measurement software and result analysis
software.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB 9706.201 Medical electrical equipment Part 2-1.Basic safety and basic
Performance Specific Requirements
GB 15213-2016 Performance and test methods of medical electron accelerators
GB/T 17857-1999 Medical Radiology Terminology (Radiation Therapy, Nuclear Medicine and Radiation Dosimetry Equipment)
3 Terms and Definitions
The following terms and definitions defined in GB 15213-2016, GB 9706.201 and GB/T 17857-1999 apply to this document.
3.1
An array composed of multiple detectors, and a dosimetry system composed of supporting measurement software and result analysis software are used to measure
The dose distribution after the radiation therapy equipment is projected, and compared with the dose distribution calculated by the treatment planning system, and the radiation dose is determined according to the specified standards.
Whether the dose distribution of the treatment equipment meets the requirements after irradiation.
4 requirements
4.1 Random files
Random documents should contain at least the following.
a) detector type;
b) Dimensions and sensitive volume of a single detector;
c) The number and spatial distribution of detectors;
d) the effective detection range of the detector array;
e) The actual thickness, composition, material, density and water equivalent thickness of the detector array;
f) Sensitivity of the detector array and its influencing factors;
g) Types of measurement rays, energy response ranges, dose ranges and dose rate ranges;
h) The minimum time sampling interval and charge collection time for measurements;
i) energy dependence of the detector array;
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