YY/T 0740-2022Particular specifications for medical X-ray angiography equipment (English PDF)
医用血管造影X射线机专用技术条件
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 18, 2022
Implementation date
May 1, 2023
Scope
YY/T 0740-2022 is the English-translated version of 医用血管造影X射线机专用技术条件.
YY/T 0740-2022 is the Chinese standard "Particular specifications for medical X-ray angiography equipment".
Its scope clause reads: 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. Its clauses include terms and definitions.
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Document preview — YY/T 0740-2022
National Standard of the People's Republic of China
- Classification
- C 43
- Replacing
- YY/T 0740-2009
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Classification and composition
- 4.1 Category
- 4.2 Composition
- 5 Requirements
- 5.1 Working conditions
- 5.2 Electric power
- 5.3 Loading factors and controls
- 5.4 Imaging performance
- 5.5 CBCT imaging performance
- 5.6 Radiation Safety
- 5.7 Mechanical device performance
- 5.8 Network and Software
- 5.9 High-voltage cable plugs and sockets
- 5.10 Noise
- 5.11 Accompanying Documents
- 5.12 Foot switch
- 5.13 Display
- 5.14 Appearance
- 5.15 Environmental test
- 5.16 Security
- 6 Test method
- 6.1 Test conditions
- 6.2 Electric power
- 6.3 Loading factors and controls
- 6.4 Imaging performance
- 6.5 CBCT Imaging Performance
- 6.6 Radiation Safety
- 6.7 Mechanical device performance
- 6.8 Network and software
- 6.9 High-voltage cable plugs and sockets
- 6.10 Noise
- 6.11 Accompanying Documents
- 6.12 Foot switch
- 6.13 Display
- 6.14 Appearance
- 6.15 Environmental test
- 6.16 Safety
- Appendix A (Normative) Test Phantom
- Appendix B (Normative) Test Layout
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.103Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
- GB 9706.228Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- GB 9706.243-2021Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
- GB 9706.254-2020Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- GB/T 10149Terminology and symbol for medical X-ray equipment
Similar standards
Editions of YY/T 0740
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0740-2022 | Particular specifications for medical X-ray angiography equipment | current edition | Current |
| YY/T 0740-2009 | Particular specifications for medical X-ray angiography equipment | previous edition | Superseded |
This page sells the current edition, YY/T 0740-2022. Earlier editions are listed for reference only.
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 — Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
GB 9706.228-2020 — Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
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YY/T 0740-2022
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