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YY/T 0740-2022: Particular specifications for medical X-ray angiography equipment
Status: Valid YY/T 0740: Evolution and historical versions
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| YY/T 0740-2022 | English | 559 |
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Particular specifications for medical X-ray angiography equipment
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YY/T 0740-2022
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| YY/T 0740-2009 | English | 759 |
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particular specification for medical X-ray angiography equipment
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PDF similar to YY/T 0740-2022
Basic data | Standard ID | YY/T 0740-2022 (YY/T0740-2022) | | Description (Translated English) | Particular specifications for medical X-ray angiography equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 27,210 | | Issuing agency(ies) | State Drug Administration | YY/T 0740-2022: Particular specifications for medical X-ray angiography 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 medical X-ray angiography equipment
ICS 11.040.50
CCSC43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0740-2009
Special technical conditions for medical angiography X-ray machines
Published on 2022-05-18
Simultaneous implementation with GB 9706.1-2020
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and composition 2
4.1 Category 2
4.2 Composition 2
5 Requirements 2
5.1 Working conditions 2
5.2 Electric power 3
5.3 Loading factors and controls 3
5.4 Imaging performance 3
5.5 CBCT imaging performance 6
5.6 Radiation Safety 6
5.7 Mechanical device performance 7
5.8 Network and Software 8
5.9 High-voltage cable plugs and sockets 8
5.10 Noise 8
5.11 Accompanying Documents 8
5.12 Foot switch 8
5.13 Display 8
5.14 Appearance 8
5.15 Environmental test 9
5.16 Security 9
6 Test method 9
6.1 Test conditions 9
6.2 Electric power 9
6.3 Loading factors and controls 9
6.4 Imaging performance 10
6.5 CBCT Imaging Performance 12
6.6 Radiation Safety 13
6.7 Mechanical device performance 14
6.8 Network and software 14
6.9 High-voltage cable plugs and sockets 15
6.10 Noise 15
6.11 Accompanying Documents 15
6.12 Foot switch 15
6.13 Display 15
6.14 Appearance 15
6.15 Environmental test 15
6.16 Safety 15
Appendix A (Normative) Test Phantom 16
Appendix B (Normative) Test Layout 22
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 of Standardization Documents"
drafted.
This document replaces YY/T 0740-2009 "Special Technical Conditions for Medical Angiography X-ray Machines".
Compared with YY/T 0740-2009, the main technical changes of this document are as follows.
--- Modified the scope (see Chapter 1, Chapter 1 of the.2009 edition);
--- Modified normative references (see Chapter 2, Chapter 2 of the.2009 edition);
--- Modified terms and definitions (see Chapter 3, Chapter 3 of the.2009 edition);
--- Modified the power supply resistance [see 5.1.2c), 5.1.2c) of the.2009 edition];
--- Modified the X-ray tube voltage (see 5.3.1, 5.3.1 of the.2009 edition);
--- Modified the X-ray tube current (see 5.3.2, 5.3.2 of the.2009 edition);
--- Removed loading time (see 5.3.3 of the.2009 edition);
--- Deleted the current time product (see 5.3.4 of the.2009 edition);
--- Modified the imaging performance (see 5.4, 5.4 of the.2009 edition);
--- Increased CBCT imaging performance (see 5.5);
--- Increased radiation safety (see 5.6);
--- Modified the performance of the mechanical device (see 5.7, 5.5 of the.2009 edition);
--- Modified the software function (see 5.8, 5.6 of the.2009 edition);
--- Deleted the liquid cooling system (see 5.7 of the.2009 edition);
--- Modified the appearance (see 5.14, 5.9 of the.2009 edition);
--- Modified the environmental test (see 5.15, 5.10 of the.2009 edition)
--- Modified security (see 5.16, 5.11 of the.2009 edition)
--- Added accompanying documents (see 5.11);
--- Added foot switch (see 5.12);
--- Added display (see 5.13);
--- Modified the test layout (see Appendix A, Appendix A of the.2009 edition);
--- Modified the test phantom (see Appendix B, Appendix B of the.2009 edition).
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This document is proposed by the State Drug Administration.
This document is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliance Standardization Sub-Technical Committee
(SAC/TC10/SC1) focal point.
This document is drafted by. Shanghai Siemens Medical Equipment Co., Ltd., Lepu (Beijing) Medical Equipment Co., Ltd., State Food and Drug Administration
Supervision and Administration of Medical Device Technology Review Center, Liaoning Provincial Medical Device Inspection and Testing Institute.
The main drafters of this document. Liu Congzhi, Kang Jie, Zhang Yujing, Miao Zhongrong, Sun Zhiyong, Wu Hui, Du Luoshan, Wang Bo, Lv Yonghui.
The previous versions of this document have been released as follows.
---YY/T 0740-2009.
Special technical conditions for medical angiography X-ray machines
1 Scope
This document specifies the terms and definitions, classifications and groups of medical angiography X-ray machines with interventional functions (referred to as vascular machines).
components, requirements and test methods.
This document applies to fixed mounted X-ray equipment claimed by the manufacturer to be suitable for angiography and interventional procedures.
This document does not apply to gastrointestinal X-ray machines and mobile C-arm X-ray machines with fluoroscopy-guided vascular intervention procedures.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance
GB 9706.103 Medical Electrical Equipment Part 1-3.General Requirements for Basic Safety and Essential Performance Collateral Standard. Diagnosis X
Radiation protection of radiation equipment
GB 9706.228 Medical Electrical Equipment Part 2-28.Special Purpose for Basic Safety and Basic Performance of Medical Diagnostic X-ray Tube Assemblies
Require
GB 9706.243-2021 Medical Electrical Equipment Part 2-43.Basic Safety and Basic Performance of Interventional X-ray Equipment
Dedicated requirements
GB 9706.254-2020 Medical electrical equipment Part 2-54.Basic safety and basic performance of X-ray photography and fluoroscopy equipment
Dedicated requirements
GB/T 10149 Terms and Symbols of Medical X-ray Equipment
GB/T 10151 Specifications for high-voltage cable plugs and sockets for medical diagnostic X-ray equipment
GB/T 19042.1-2003 Evaluation and routine tests of medical imaging departments - Part 3-1.For X-ray photography and fluoroscopy systems
X-ray equipment imaging performance acceptance test
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
YY/T 0590.3-2011 Characteristics of Digital X-ray Imaging Devices for Medical Electrical Equipment Part 1-3.Measurement of Quantum Detection Efficiency
Detector for stationary and dynamic imaging
YY/T 0910.1-2013 Medical Imaging Display System for Medical Electrical Equipment Part 1.Evaluation Method
YY 1057-2016 General technical conditions for medical foot switches
YY 9706.102 Medical Electrical Equipment Part 1-2.General Requirements for Basic Safety and Essential Performance Collateral Standard. Electromagnetic Compatibility
Requirements and Tests
3 Terms and Definitions
GB/T 10149 and the following terms and definitions apply to this document.
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