Detail of YY/T 0742-2021

Introduction of YY/T 0742-2021

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