YY/T 0740-2022 in English

YY/T 0740-2022 Particular specifications for medical X-ray angiography equipment

1 Scope

This document specifies the terms and definitions, classification and composition, requirements, and test methods for medical X-ray angiography equipment with interventional operation function (hereinafter referred to as "angiography equipment").

This document is applicable to fixed X-ray equipment that is claimed by the manufacturer as suitable for angiography and interventional treatment.

This document is not applicable to gastrointestinal diagnostic X-ray equipment and mobile C-arm X-ray equipment with the function of radioscopically guided interventional procedure.

2 Normative references

The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

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: Radiation protection in diagnostic X-ray equipment
GB 9706.228 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
GB 9706.243-2021 Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
GB 9706.254-2020 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
GB/T 10149 Terminology and symbol for medical X-ray equipment
GB/T 10151 Medical diagnostic X-ray equipment - Specifications for high voltage cable plugs and sockets
GB/T 19042.1-2003 Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance test-Imaging performance of X-ray equipment for radiographic and radioscopic systems
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
YY/T 0590.3-2011 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
YY/T 0910.1-2013 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
YY 1057-2016 General specifications for medical foot switch
YY 9706.102 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
DICOM 3.0 Digital Imaging and Communications in Medicine PS3 (https://www.dicomstandard.org/standard/)

3 Terms and definitions

For the purposes of this document, the terms and definitions given in GB/T 10149 and the following apply.

3.1
radioscopy image subtraction
digital image processing method for subtracting radioscopic sequence images

3.2
radiography image subtraction
digital image processing method for subtracting radiographic sequence images

Note 1: Compared with "radiography image subtraction", "radioscopy image subtraction" requires a higher dose of X-rays and results in subtracted images with higher quality.

Note 2: "Digital subtraction" includes "radiography image subtraction" and "radioscopy image subtraction", which have different clinical applications.

Note 3: "Digital subtraction angiography (DSA)" refers to the application of "digital subtraction" in angiography, typically in the form of "radiography image subtraction".

3.3
radioscopy recovery time
time required for the system to power back on and be ready for radioscopy operations after a power outage of the equipment during radioscopy

3.4
radioscopy imaging stability time
time required from the first radioscopy image to a stable image during the automatic brightness control process

3.5
cone beam computed tomography; CBCT
computed tomography using cone beam X-ray imaging

4 Classification and composition

4.1 Classification

Angiography equipment may be classified into universal X-ray angiography equipment, X-ray angiocardiography equipment and X-ray peripheral angiography equipment according to the intended use of the product.

Angiography equipment may be classified into X-ray angiography equipment with image intensifier and X-ray angiography equipment with digital flat panel detector according to different image receptors.

4.2 Composition

The angiography equipment generally consists of X-ray generator, rack, patient support device, imaging systems, and other components.

5 Requirements

5.1 Working conditions

Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and composition
4.1 Classification
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 Plugs and sockets for high voltage cables
5.10 Noise
5.11 Accompanying documents
5.12 Foot switch
5.13 Display
5.14 Appearance
5.15 Environmental test
5.16 Safety
6 Test methods
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 Plugs and sockets for high voltage cables
6.10 Noise
6.11 Accompanying documents
6.12 Foot switch
6.13 Display
6.14 Appearance
6.15 Environmental test
6.16 Safety
Annex A (Normative) Test phantom
Annex B (Normative) Test layouts