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Performance characteristics and test methods of imaging system of single photon emission and X-ray computed tomograph
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Basic data Standard ID | YY/T 1408-2016 (YY/T1408-2016) | Description (Translated English) | Performance characteristics and test methods of imaging system of single photon emission and X-ray computed tomograph | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C43 | Classification of International Standard | 11.040.50 | Word Count Estimation | 13,124 | Date of Issue | 2016-03-23 | Date of Implementation | 2017-01-01 | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | Issuing agency(ies) | State Food and Drug Administration |
YY/T 1408-2016: Performance characteristics and test methods of imaging system of single photon emission and X-ray computed tomograph ---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.
Performance characteristics and test methods of imaging system of single photon emission and X-ray computed tomograph
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standard
Single photon emission and X - ray computed tomography
System performance and test methods
Performancecharacteristics andtestmethodsofimagingsystemofsinglephoton
2016-03-23 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
Introduction IV
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
Performance and test methods
Appendix A (informative) NEMA Standard Publication NU1-2007 "Single Photon Emission Tomography Imaging Performance Test" 8
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Electrical Appliances Standardization Technical Committee of Radiation Therapy, Nuclear Medicine and Radiation Dosing Equipment Subcommittee
(SAC/TC10/SC3).
The drafting of this standard. Beijing Medical Device Testing Institute, Shanghai Yingying Medical Technology Co., Ltd., General Electric Medical System Trade
(Shanghai) Co., Ltd., Siemens (China) Co., Ltd., Philips (China) Investment Co., Ltd., Liaoning Province, medical equipment testing.
The main drafters of this standard. Feng Jian, Chen Mu, Meng Fanbo, Nie Tao, Yu Bin, Miao Bin, Li Zhizhuo, Wang Yunshan.
Introduction
Performance and test methods for single photon emission tomography in single photon emission and X-ray computed tomography systems
GB/T 18989-2013, GB/T 18988.2-2013, GB/T 18988.3-2013 related content, X-ray computed tomography
Like part of the performance and test methods cited YY/T 0310-2015 related content.
GB/T 18988.2-2013, GB/T 18988.3-2013, GB/T 18989-2013 were modified using IEC 61675-2.
1998, IEC 61675-3..1998, IEC 60789..1992.
At present, the production sites of the major manufacturers of radionuclide imaging equipment are located in the United States, its reported parameters, data processing software,
Test body are the American Electrical Manufacturers Association (NEMA) as the basis for the design basis, there are manufacturers using IEC standards. For that
In the government, enterprises and medical institutions to understand and use these products IEC and NEMA two series of standards, the NEMA standard
Publication Contents NU1-2007 "Single Photon Emission Tomography Imaging Performance Test" is included as an informative Appendix A.
As the IEC standard and NEMA standards in the test requirements, test methods, there are some differences, the use of the mold, test conditions, testing
Location, calculation methods are different, so the two standard test items can not be compared between each other, it is recommended that the standard user a complete reference to two
Any kind of method, not cross the use.
Single photon emission and X - ray computed tomography
System performance and test methods
1 Scope
This standard specifies the performance and testing of single photon emission and X-ray computed tomography systems (hereinafter referred to as "SPECT/CT")
method.
This standard applies to SPECT/CT, does not apply to independent single photon emission tomography (hereinafter referred to as "SPECT") and independent
X-ray computed tomography equipment (hereinafter referred to as "CT").
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 17857-1999 Medical radiology terminology (Radiation therapy, nuclear medicine and radiation dosimetry equipment)
GB/T 18988.2-2013 Radionuclide imaging equipment Performance and test rules - Part 2. Single photon emission computed
Layer imaging device
GB/T 18988.3-2013 Radionuclide imaging equipment Performance and test rules - Part 3. Gamma camera body imaging
system
GB/T 18989-2013 Radionuclide imaging equipment Performance and test rules Gamma camera
General technical requirements for X - ray computed tomography equipment YY/T 0310-2015
3 terms and definitions
GB/T 17857-1999, GB/T 18988.2-2013, GB/T 18988.3-2013, GB/T 18989-2013, YY/T 0310-
2015 and the following terms and definitions apply to this document.
3.1
Image registration imageregistration
The process of transforming different image datasets to the same coordinate system. Different image data sets refer to different times and/or different pattern pairs
An object is acquired by the acquired data set.
4 performance and test methods
4.1 SPECT performance and test methods
4.1.1 Overview
If the user is required to refer to the method of Appendix A, it is recommended that the contents of this chapter and Appendix A should not be cross-referenced.
4.1.2 System plane sensitivity
According to GB/T 18989-2013 3.1 in the test method specified.
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