Standard No.:	YY/T 0741-2018
English Name:	Particular specifications for digital X-ray radiography system
Chinese Name:	数字化摄影X射线机专用技术条件
Chinese Classification:	C43    Medical radiographic equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.50 11.040.50    Radiographic equipment 11.040.50
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2018-09-28
Implemented on:	2019-10-1
Status:	valid
Superseding:	YY/T 0741-2009 General specifications for digital medical X-ray radiography system
Target Language:	English
File Format:	PDF
Word Count:	8500 words
Translation Price(USD):	140.0
Delivery:	via email in 1 business day

YY/T 0741-2018 Particular specifications for digital X-ray radiography system 1 Scope This standard specifies the terms and definitions, system composition, requirements and test methods of digital radiography system (hereinafter referred to as "DR system"). This standard is applicable to DR systems for ordinary X-ray radiography. Including but not limited to DR system that adopts linear array scanning or area array scanning detectors, for example: ——DR system that adopts flat panel detectors (FPD); ——DR system that adopts area array CCD detectors; ——DR system that adopts linear array sweeping CCD detectors; ——DR system that adopts CMOS detectors. This standard is applicable to each digital X-ray image detector and the X-ray generator used for imaging in DR systems that adopt more than one digital X-ray image detectors. This standard is not applicable to systems using X-ray image intensifiers, systems using X-ray radiography image plate imaging devices, mammography X-ray equipment, dental X-ray equipment, computed tomography equipment, and mobile DR systems. 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 9706.3-2000 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 9706.12-1997 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 9706.15 Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems GB/T 10151 Medical diagnostic X-ray equipment - Specifications for high voltage cable plugs and sockets YY/T 0291 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 SAE M3.0 (All parts) Digital imaging and communications in medicine 3 Terms and definitions For the purposes of this document, the terms and definitions given in the normative references, as well as the following apply. 3.1 digital radiography system device in which X-ray radiography is achieved by using digital X-ray image detector technology. It is usually composed of an X-ray generator, digital X-ray imaging device and auxiliary equipment 3.2 digital X-ray imaging device system that using digital X-ray image detectors to provide digital format projected images, composed of subsystems capable of image processing, displaying, printing or storage 3.3 digital X-ray image detector converter that converts the image information in the form of optical quantum into digital electronic form after spatially sampling X-rays using a linear array or matrix pixel 3.4 imaging time time required from the start of exposure to the display of a normal image on the screen that meets the diagnostic needs 3.5 information management software measures for managing patient information, such as appointment, registration, modification, deletion, query, statistics and backup management

Contents Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 System composition 5 Requirements 6 Test methods Annex A (Normative) Test layouts Annex B (Informative) Test phantoms Annex C (Informative) Preparation instructions of some clauses/subclauses