YY/T 0742-2021 Particular specifications for gastrointestinal diagnostic X-ray equipment
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements, and test methods for gastrointestinal diagnostic X-ray equipment (hereinafter referred to as "gastrointestinal equipment").
This standard is applicable to X-ray equipment claimed by the manufacturer to be intended for fluoroscopic and radiographic examinations of the gastrointestinal tract and for obtaining images for clinical diagnosis.
2 Normative references
The following referenced documents are indispensable for the application 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 safety
GB 9706.3 Medical electrical equipment - Part 2: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
GB 9706.11 Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
GB 9706.12 Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
GB 9706.14 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
GB/T 10149-1988 Terminology and symbol for medical X-ray equipment
GB/T 10151-2008 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 0291-2016 Environmental requirements and test methods for medical X-ray equipment
YY 0505 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests
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 0608-2013 General specifications for X-ray image intensifier TV system for medical diagnosis
YY/T 0910.1 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
YY 1057-2016 General specifications for medical foot switch
IEC 61910-1:2014 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
DICOM 3.0 Digital imaging and communications in medicine
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1, GB/T 10149-1988, GB/T 19042.1-2003 and YY/T 0608-2013, as well as the following apply.
3.1
fluoroscopy imaging stability time
time required from the first fluoroscopic image to a stable image during the automatic brightness control process
3.2
precision of fluoroscopic image stabilization
automatic control capability to keep the image brightness unchanged after a change in the fluoroscopic object
3.3
prepare time for spot film
time from pressing the radiography switch to the production of X-rays during fluoroscopy
4 Classification and composition
4.1 Classification
The fluoroscopic imaging methods of gastrointestinal equipment are classified into:
——Fluoroscopy;
——Fluoroscopy with X-ray image intensifier TV system;
——Fluoroscopy with X-ray image intensifier digital image system;
——Fluoroscopy with flat panel detector digital image system;
Foreword I
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and composition
5 Requirements
6 Test methods
Annex A (Normative) Test layout
Annex B (Normative) Test phantom
YY/T 0742-2021 Particular specifications for gastrointestinal diagnostic X-ray equipment
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements, and test methods for gastrointestinal diagnostic X-ray equipment (hereinafter referred to as "gastrointestinal equipment").
This standard is applicable to X-ray equipment claimed by the manufacturer to be intended for fluoroscopic and radiographic examinations of the gastrointestinal tract and for obtaining images for clinical diagnosis.
2 Normative references
The following referenced documents are indispensable for the application 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 safety
GB 9706.3 Medical electrical equipment - Part 2: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
GB 9706.11 Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
GB 9706.12 Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
GB 9706.14 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
GB/T 10149-1988 Terminology and symbol for medical X-ray equipment
GB/T 10151-2008 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 0291-2016 Environmental requirements and test methods for medical X-ray equipment
YY 0505 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests
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 0608-2013 General specifications for X-ray image intensifier TV system for medical diagnosis
YY/T 0910.1 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
YY 1057-2016 General specifications for medical foot switch
IEC 61910-1:2014 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
DICOM 3.0 Digital imaging and communications in medicine
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1, GB/T 10149-1988, GB/T 19042.1-2003 and YY/T 0608-2013, as well as the following apply.
3.1
fluoroscopy imaging stability time
time required from the first fluoroscopic image to a stable image during the automatic brightness control process
3.2
precision of fluoroscopic image stabilization
automatic control capability to keep the image brightness unchanged after a change in the fluoroscopic object
3.3
prepare time for spot film
time from pressing the radiography switch to the production of X-rays during fluoroscopy
4 Classification and composition
4.1 Classification
The fluoroscopic imaging methods of gastrointestinal equipment are classified into:
——Fluoroscopy;
——Fluoroscopy with X-ray image intensifier TV system;
——Fluoroscopy with X-ray image intensifier digital image system;
——Fluoroscopy with flat panel detector digital image system;
Contents of YY/T 0742-2021
Foreword I
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and composition
5 Requirements
6 Test methods
Annex A (Normative) Test layout
Annex B (Normative) Test phantom
