Standard No.:	YY/T 0744-2018
English Name:	Particular specifications for mobile C-arm X-ray equipment
Chinese Name:	移动式C形臂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
Issued by:	China Food and Drug Adminstration
Issued on:	2018-01-19
Implemented on:	2019-1-1
Status:	valid
Superseding:	YY/T 0744-2009 Particular specifications for mobile C-arm X-ray equipment
Language:	English
File Format:	PDF
Word Count:	12500 words
Price(USD):	370.0
Delivery:	via email in 1 business day

YY/T 0744-2018 Particular specifications for mobile C-arm X-ray equipment 1 Scope This standard specifies the terms and definitions, classification and composition, requirements, and test methods for mobile C-arm X-ray equipment (hereinafter referred to as "C-arm X-ray equipment"). This standard is applicable to mobile X-ray equipment with a C-arm mechanical support device, which are mainly used for positioning and examination in surgical operations in medical and health institutions. This standard is not applicable to C-arm X-ray equipment with a maximum focal spot to image receptor distance (SID) of less than 60cm. 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 9706.1-2007 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 9706.11-1997 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 9706.14-1997 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment GB 9706.15-2008 Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems GB 9706.23-2005 Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures 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 YY 0076-1992 Coating classifications for metal product - Technical conditions YY/T 0106-2008 General specifications for medical diagnostic X-ray equipment 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 standard: Electromagnetic compatibility - Requirements and tests IEC 61910-1:2014 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy 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 fluoroscopy spot image an image obtained through superimposition of acquired multi-frame fluoroscopic images, which has a higher signal-to-noise ratio compared to ordinary fluoroscopic images 3.2 fluoroscopy image subtraction digital image processing method for subtracting fluoroscopic sequence images 3.3 radiography image subtraction digital image processing method for subtracting radiographic sequence images Note 1: Compared with "fluoroscopy image subtraction", "radiography 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 "fluoroscopy 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". 3.4 fluoroscopy recovery time time required for the system to power back on and be ready for fluoroscopy operations after a power outage of the equipment during fluoroscopy 3.5 imaging time time required from the generation of X-rays to the display of the first image on the screen 3.6 fluoroscopy imaging stability time time required from the first fluoroscopic image to a stable image during the automatic brightness control process 4 Classification and composition 4.1 Classification

Foreword I 1 Scopeno less than 2 Normative references 3 Terms and definitions 4 Classification and composition 5 Requirements 6 Test methods Annex A (Normative) Test layouts Annex B (Normative) Test phantoms Annex C (Normative) Test method for correction factor g