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YY/T 0744-2018

Chinese Standard: 'YY/T 0744-2018'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0744-2018English449 Add to Cart Days<=5 Particular specifications for mobile C-arm X-ray equipment Valid YY/T 0744-2018
YY/T 0744-2018Chinese19 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

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BASIC DATA
Standard ID YY/T 0744-2018 (YY/T0744-2018)
Description (Translated English) Particular specifications for mobile C-arm X-ray equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 25,245
Date of Issue 2018-01-19
Date of Implementation 2019-01-01
Older Standard (superseded by this standard) YY/T 0744-2009
Quoted Standard GB 9706.1-2007; GB 9706.3-2000; GB 9706.11-1997; GB 9706.12-1997; GB 9706.14-1997; GB 9706.15-2008; GB 9706.23-2005; GB/T 10149; GB/T 10151; YY 0076-1992; YY/T 0106-2008; YY/T 0291; YY 0505; IEC 61910-1-2014
Drafting Organization Shanghai Siemens Medical Devices Co., Ltd
Administrative Organization National Medical Electrical Appliance Standardization Technical Committee Medical X-ray Equipment and Appliance Sub-technical Committee
Regulation (derived from) China Food and Drug Administration announced No. 8 of 2018
Summary This standard specifies the terms and definitions, classification, composition, requirements and test methods of mobile C-arm X-ray machines (hereinafter referred to as C-arm X-ray machines). This standard applies to mobile X-ray machines with C-arm mechanical support devices. This product is mainly used for positioning and inspection in surgical operations of medical and health institutions. This standard does not apply to C-arm X-ray machines with a maximum focus-image receiver distance (SID) of less than 60 cm.

YY/T 0744-2018
Particular specifications for mobile C-arm X-ray equipment
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 0744-2009
Special technical conditions for mobile C-arm X-ray machine
2018-01-19 release
2019-01-01 Implementation
Issued by the State Food and Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0744-2009 "Special technical conditions for mobile C-arm X-ray machine", which is in line with YY/T 0744-2009
The main technical changes are as follows.
--- Modified the scope and added "This standard does not apply to the C-arm X with the maximum focus-image receiver distance (SID) less than 60cm
Ray machine "(see Chapter 1);
--- Added terms and definitions "perspective film"; "perspective image subtraction"; "photographic image subtraction"; "perspective recovery time"; "when imaging
Time ";" Perspective image stabilization time "(see Chapter 3);
--- Modified the classification (see 4.1);
--- Modified electric power (see 5.2);
--- Modified loading factors and controls (see 5.3);
--- Modified the imaging performance (see 5.4);
--- Increased radiation safety (see 5.5);
--- Modify the mechanical device performance clause number (see 5.6), and increase the requirements for sports protection (see 5.6.3);
--- Added software function (see 5.7);
--- Modified the appearance of the article number (see 5.10);
--- Modified the safety clause number (see 5.12) and added "If the manufacturer claims that the C-arm X-ray machine has fluoroscopic guidance intervention
The operation function shall meet the requirements of GB 9706.23 ";
--- Added test layout (see Appendix A);
--- Added test phantom (see Appendix B);
--- Added the correction factor g test method (see Appendix C).
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is subordinated to the Technical Committee for Medical X-ray Equipment and Appliances of the National Medical Appliance Standardization Technical Committee (SAC/TC10/SC1)
Be in charge.
This standard was drafted by. Shanghai Siemens Medical Devices Co., Ltd. and State Food and Drug Administration under review
Xin, Nanjing Puai Radiographic Equipment Co., Ltd., Liaoning Medical Device Inspection and Testing Institute.
The main drafters of this standard. Liu Congzhi, Zhang Yujing, Zhao Zhengwen, Zhang Yong, Li Lu, Gao Bing.
The previous versions of the standard replaced by this standard are as follows.
--- YY/T 0744-2009.
Special technical conditions for mobile C-arm X-ray machine
1 Scope
This standard specifies the terms and definitions, classification, composition and requirements of mobile C-arm X-ray machine (hereinafter referred to as C-arm X-ray machine)
Sum test method.
This standard applies to mobile X-ray machines with a C-arm mechanical support device, which is mainly used for surgical operations in medical and health institutions
Positioning and inspection in the. This standard does not apply to C-arm X-ray machines with a maximum focus-image receiver distance (SID) of less than 60 cm.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB 9706.1-2007 Medical electrical equipment Part 1. General requirements for safety
GB 9706.3-2000 Medical electrical equipment Part 2. Special safety requirements for high-voltage generators for diagnostic X-ray generators
GB 9706.11-1997 Medical electrical equipment Part 2. Particular requirements for the safety of medical diagnostic X-ray source components and X-ray tube components
GB 9706.12-1997 Medical electrical equipment Part 1. General requirements for safety III. Parallel standard diagnostic X-ray equipment
General requirements for radiation protection
GB 9706.14-1997 Medical electrical equipment Part 2. Particular requirements for the safety of auxiliary equipment of X-ray equipment
GB 9706.15-2008 Medical electrical equipment Part 1-1. General requirements for safety Parallel standards. Medical electrical system safety
Claim
GB 9706.23-2005 Medical electrical equipment Part 2-43. Particular requirements for the safety of interventional X-ray equipment
GB/T 10149 Medical X-ray equipment terms and symbols
GB/T 10151 Technical conditions for high-voltage cable plugs and sockets of medical diagnostic X-ray equipment
YY 0076-1992 Technical requirements for classification of coatings made of metal
YY/T 0106-2008 General technical requirements for medical diagnostic X-ray machine
YY/T 0291 Environmental requirements and test methods of medical X-ray equipment
YY 0505 Medical electrical equipment Part 1-2. General requirements for safety Parallel standards. Electromagnetic compatibility requirements and tests
IEC 61910-1..2014 Medical Electrical Equipment Radiation Dose Document Part 1. Structured Radiation Dose for Photography and Perspective Equipment
Report (Medicalelectricalequipment-Radiationdosedocumentation-Part 1. Radiationdosestructured
reportsforradiographyandradioscopy)
3 Terms and definitions
The terms and definitions defined in GB/T 10149 and the following apply to this document.
3.1
Perspective fluoroscopyspotimage
An image obtained by superimposing the collected multi-frame perspective images (having a higher signal-to-noise ratio than ordinary perspective images).
3.2
Fluoroscopyimagesubtraction
Digital image processing method for subtraction of perspective sequence images.
Related standard:   YY/T 0741-2018  YY/T 0590.1-2018
Related PDF sample:   YY/T 0741-2018  YY/T 0741-2009
   
 
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