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YY/T 0742-2021: Particular specifications for gastrointestinal diagnostic X-ray equipment
Status: Valid YY/T 0742: Evolution and historical versions
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| YY/T 0742-2021 | English | 449 |
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Particular specifications for gastrointestinal diagnostic X-ray equipment
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YY/T 0742-2021
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| YY/T 0742-2009 | English | 439 |
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particular specification for gastrointestinal diagnostic X-ray equipment
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YY/T 0742-2009
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PDF similar to YY/T 0742-2021
Basic data | Standard ID | YY/T 0742-2021 (YY/T0742-2021) | | Description (Translated English) | Particular specifications for gastrointestinal diagnostic X-ray equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 24,249 | | Issuing agency(ies) | State Drug Administration | YY/T 0742-2021: Particular specifications for gastrointestinal diagnostic X-ray equipment---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.
Particular specifications for gastrointestinal diagnostic X-ray equipment
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standards
Replace YY/T 0742-2009
Special technical conditions for gastrointestinal X-ray machine
Released on 2021-03-09
2022-04-01 implementation
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Classification and composition 2
5 Requirements 2
6 Test method 10
Appendix A (Normative Appendix) Test Layout 18
Appendix B (Normative Appendix) Test Phantom 19
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0742-2009 "Special technical conditions for gastrointestinal X-ray machines", compared with YY/T 0742-2009, except for editing
In addition to the modification, the main technical changes are as follows.
---Modified the scope (see Chapter 1,.2009 edition);
---Modified the normative reference documents (see Chapter 2, Chapter 2 of the.2009 edition);
---Modified the terms and definitions "perspective image brightness stability" and "perspective image stabilization time" (see 3.2, 3.1,.2009 edition
3.1, 3.2);
---Added terms and definitions "preparation time for point-and-shoot photography" (see 3.3);
---Modified the classification and composition (see Chapter 4, Chapter 4 of the.2009 edition);
---Modified loading factors and control (see 5.3 and 6.3, 5.3 and 6.3 of the.2009 edition);
---Modified the imaging performance of indirect X-ray fluoroscopy and indirect X-ray photography (see 5.4 and 6.4, the.2009 edition of 5.4.2, 5.4.3,
6.4.2 and 6.4.3);
--- Increased radiation safety (see 5.5, 6.5);
---Modified the weight bearing of the gastrointestinal diagnostic bed (see 5.6.10 and 6.6.10, 5.5 and 6.5 in the.2009 edition);
---Added accompanying documents (see 5.8, 6.8);
---Added a foot switch (see 5.9, 6.9);
---Increase the display (see 5.10, 6.10);
---Added network and software (see 5.12, 6.12);
---Modified the environmental test (see 5.15 and 6.15, 5.12 and 6.12 of the.2009 edition);
---Modified security (see 5.16 and 6.16, 5.13 and 6.13 of the.2009 edition);
---Added the test layout and test phantom (see Appendix A, Appendix B).
Please note that the content of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is organized by the National Medical Electrical Appliance Standardization Technical Committee Medical X-ray Equipment and Appliance Sub-Technical Committee (SAC/TC10/SC1)
Focus.
Drafting organizations of this standard. Beijing Wandong Medical Technology Co., Ltd., Shanghai Siemens Medical Devices Co., Ltd., Beijing Langshi Instruments
Co., Ltd., Liaoning Provincial Medical Device Inspection and Testing Institute, Shanghai Changhai Hospital, Shanghai Yirui Optoelectronic Technology Co., Ltd.
The main drafters of this standard. Xu Qiang, Liu Congzhi, Lu Jinming, Jin Yubo, Sun Zhiyong, Hu Lianghao, Zhang Nan.
The previous versions of the standard replaced by this standard are as follows.
---YY/T 0742-2009.
Special technical conditions for gastrointestinal X-ray machine
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements, and test methods of gastrointestinal X-ray machines (hereinafter referred to as gastrointestinal machines).
This standard applies to the intended use declared by the manufacturer for gastrointestinal X-ray fluoroscopy and photographic examination and to obtain images for clinical diagnosis
X-ray machine used.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Safety
GB 9706.3 Medical electrical equipment Part 2.Special requirements for the safety of high-voltage generators for diagnostic X-ray generators
GB 9706.11 Medical electrical equipment Part 2.Special requirements for the safety of medical diagnostic X-ray source components and X-ray tube components
GB 9706.12 Medical electrical equipment Part 1.General safety requirements III. Parallel standards for radiation protection of diagnostic X-ray equipment
common enquiries
GB 9706.14 Medical electrical equipment Part 2.Special requirements for the safety of auxiliary equipment of X-ray equipment
GB/T 10149-1988 Medical X-ray equipment terms and symbols
GB/T 10151-2008 Technical requirements for high-voltage cable plugs and sockets for medical diagnostic X-ray equipment
GB/T 19042.1-2003 Evaluation and routine tests in medical imaging departments Part 3-1.For X-ray photography and fluoroscopy systems
X-ray equipment imaging performance acceptance test
YY/T 0291-2016 Environmental requirements and test methods for medical X-ray equipment
YY 0505 Medical Electrical Equipment Part 1-2.General Safety Requirements Collateral Standard. Electromagnetic Compatibility Requirements and Tests
YY/T 0590.3-2011 Characteristics of digital X-ray imaging devices for medical electrical equipment Part 1-3.Quantum detection efficiency
Detector for measuring dynamic imaging
YY/T 0608-2013 General technical conditions for medical X-ray image intensifier TV system
YY/T 0910.1 Medical image display system for medical electrical equipment Part 1.Evaluation method
YY 1057-2016 General technical conditions for medical foot switches
IEC 61910-1.2014 Medical electrical equipment radiation dose document Part 1.Photography and fluoroscopy equipment radiation dose structure
Report (Medicalelectricalequipment-Radiationdosedocumentation-Part 1.Radiationdosestructured
reportsforradiographyandradioscopy)
DICOM3.0 Digital Imaging and Communications in Medicine (Digital Imaging and Communications in Medicine).
3 Terms and definitions
GB 9706.1, GB/T 10149-1988, GB/T 19042.1-2003 and YY/T 0608-2013 and the following terms defined
And definitions apply to this document.
3.1
Fluoroscopyimagingstabilitytime fluoroscopyimagingstabilitytime
In the process of automatic brightness control, the time from the first perspective image to the stable image.
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