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YY/T 0706-2017 (YYT 0706-2017)

YY/T 0706-2017_English: PDF (YYT0706-2017)
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YY/T 0706-2017English439 Add to Cart 5 days Particular specifications for mammographic X-ray equipment YY/T 0706-2017 Valid YY/T 0706-2017

Standard ID YY/T 0706-2017 (YY/T0706-2017)
Description (Translated English) Particular specifications for mammographic 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 22,295
Date of Issue 2017-03-28
Date of Implementation 2018-04-01
Older Standard (superseded by this standard) YY/T 0706-2008
Drafting Organization Liaoning Province, Medical Device Testing Institute, Shenyang Neusoft Medical Systems Co., Ltd., Shenzhen St. Connaught Medical Equipment Co., Ltd.
Administrative Organization National Medical Appliance Standardization Technical Committee Medical X-ray equipment and appliances Standardization Technical Committee (SAC/TC 10/SC 1)
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 38
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 0706-2017
Particular specifications for mammographic X-ray equipment
ICS 11.040.50
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0706-2008
Technical conditions for mammography
Released on.2017-03-28
2018-04-01 implementation
State Food and Drug Administration issued
Foreword I
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and composition 2
5 Requirements 2
6 Test method 6
Appendix A (informative) Low contrast test phantom 13
Appendix B (informative) Breast imaging phantom 15
Appendix C (Normative Appendix) Mammary mean dose gland calculation 17
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0706-2008 "Technical Conditions for Mammography X-ray Machines".
Compared with YY/T 0706-2008, the main technical changes of this standard are as follows.
--- Modified the "scope" (see Chapter 1);
---Modified "normative references" (see Chapter 2);
---Modified "terms and definitions" (see Chapter 3);
--- Modified "Classification and Composition" to increase the content of digital mammography machines (see Chapter 4);
--- Revised "specified by product standards" to "specified by the manufacturer" (see Chapter 5, Chapter 6);
--- Modified "Load factor control and display" (see 5.3);
--- Modified the "Automatic Exposure Control (AEC) System" (see 5.4.1);
--- Modified "artifacts" (see 5.4.2);
---Modified the "Imaging Performance" section (see 5.4.3, 5.4.4, 5.4.5, 5.4.6, 5.4.7, 5.4.8);
---Modified "mechanical movement" (see 5.5.1);
---Modified "compression device" (see 5.5.2);
--- Modified the "pressure plate" (see 5.5.3);
---Modified "braking force" (see 5.5.4);
---Modified the "mobile performance of mobile mammography machine" (see 5.5.7);
--- Modified "bearing weight" (see 5.5.8);
---Modified "noise" (see 5.5.9);
--- Added "angle indication value" (see 5.5.6);
---Modified "high-voltage cable plugs and sockets" (see 5.7);
--- Removed "Continuous loading 3min";
---Modified part of "Load factor control and display" (see 6.3);
--- Modified the "Automatic Exposure Control (AEC) System" (see 6.4.1);
--- Modified "artifacts" (see 6.4.2);
--- Removed "total filtration", "material decay rate between the upper surface of the breast tray and the image receptor plane", "active anti-scatter filter
"Dilution of wire shadow", "high contrast resolution";
--- Added "afterimage", "anti-scatter filter grid", "spatial resolution low contrast resolution", "mammary gland dose", "digital
Image uniformity" (see 6.4.3, 6.4.4, 6.4.5, 6.4.6, 6.4.7, 6.4.8);
---Modified "mechanical device performance" (see 6.5.1, 6.5.2, 6.5.3, 6.5.4, 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9);
---Modified "high-voltage cable plugs, sockets", "environmental requirements", "safety and electromagnetic compatibility requirements" (see 6.7, 6.9, 6.10);
--- Added Appendix A, Appendix B and Appendix C.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is determined by the National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliance Standardization Subcommittee (SAC/
TC10/SC1) is in charge.
This standard was drafted. Liaoning Medical Device Inspection and Testing Institute, Shenyang Neusoft Medical System Co., Ltd., Shenzhen Shengnuo Medical Equipment
Limited company.
The main drafters of this standard. Shan Xu, Hou Yaofang, Liang Tiecheng, Ye Chengfu, Liu Jingbo.
This standard replaces YY/T 0706-2008.
The previous versions of the standards replaced by this standard are.
---YY/T 0706-2008.
Technical conditions for mammography
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements and test methods of mammography machines (hereinafter referred to as mammography machines).
This standard applies to