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General specifications for X-ray image intensifier TV system for medical diagnosis
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YY/T 0608-2013
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General specifications for X-ray image intensifier TV system for medical diagnosis
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Basic data | Standard ID | YY/T 0608-2013 (YY/T0608-2013) | | Description (Translated English) | General specifications for X-ray image intensifier TV system for medical diagnosis | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 21,221 | | Older Standard (superseded by this standard) | YY/T 0608-2007 | | Quoted Standard | GB 9706.1-2007; GB/T 10149-1988; YY/T 0291-2007 | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the terms and definitions, requirements and test methods related to medical X-ray image intensifier television system. This standard applies to the use of medical X-ray image intensifiers for medical X-ray fluoroscopy X-ray image i |
YY/T 0608-2013: General specifications for X-ray image intensifier TV system for medical diagnosis ---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
General specifications for X-ray image intensifier TV system for medical diagnosis
ICS 11.040.50
C43
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0608-2007
Medical X-ray image intensifier television system
General technical conditions
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 requires 2
4.1 effective incident field size 2
4.2 3 image distortion
4.3 contrast range 3
4.4 Identification of image gray level 3
4.5 line pair resolution 3
4.6 Low contrast resolution 3
4.7 image brightness stabilization signal 3
4.8 Video Output Voltage 3
4.9 Environmental Test 3
Security 3 4.10
Test Method 4 5
5.1 effective incident field size 4
5.2 5 image distortion
Contrast range 5.3 5
5.4 Identification of the gray level image 6
5.5 line pair resolution 6
5.6 Low contrast resolution 7
5.7 stable image brightness signal 7
5.8 video output voltage 7
8 5.9 Environmental Testing
Safety 8 5.10
Appendix A (normative) video output voltage measurement layout 9
Appendix B (normative) vision and image distortion measurement layout 10
Annex C (normative) Identification of the gray level image layout measuring 11
Annex D (informative) image gray level test identification card 12
Annex E (informative) low-contrast resolution test card 13
Annex F (informative) line pair resolution test card 14
Annex G (informative) vision and image distortion test card 15
Appendix H (informative) test parameters, symbols and units 16
1 video output voltage Figure 4
Figure A.1 video output signal measurement layout 9
Figure B.1 vision and image distortion measurement layout 10
Figure C.1 gray image authentication hierarchical layout measuring 11
Figure D.1 image gray level test identification card 12
Figure E.1 low contrast resolution test card 13
Figure G.1 vision and image distortion test card 15
Table 1 Nominal entrance field and resolution requirements for line 3
Recommended values in Table 2 y value of 5
Table D.1 Table 12 copper thickness ladder
Table E.1 low contrast resolution test card 13
Table F.1 Recommended grouping line test card 14
Table H.1 test parameters, symbols and units 16
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
With the increasingly widespread use of digital technology, medical X-ray imaging has been varying degrees of integration of digital technology. For Medical
Terms of use X-ray image intensifier television system, with the gradual deepening of digital technology, the original evaluation of medical X-ray image intensifiers
The TV system approach has changed. To make these new methods of standardization in the 2007 version of the standard was revised.
Instead of the standard YY/T 0608-2007 "medical X-ray image intensifier television system General technical conditions";
Compared with YY/T 0608-2007 The main technical differences are as follows.
--- Modify the description of the scope of the standard, to avoid the installation of medical X-ray image intensifier television system of medical X-ray machine
Unable to cite this standard problem;
--- Remove the "incident air kerma rate" requirements and test methods;
--- Low contrast resolution requirements from 2% to 4.4%;
--- 5.4,5.5,5.6 original terms of reference GB 19042.1-2003 changed directly describe;
--- Added Appendix H test parameters, symbols and units;
--- Removed YY/T 0457.4-2003 of reference. Terms of reference defined directly.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the National Standardization Technical Committee medical electrical medical X-ray equipment and utensils Standardization Technical Committee
(SAC/TC10/SC1) centralized.
This standard was drafted. Space Star Space Applications Technology Co., Ltd., Liaoning Medical Device Control, Shanghai Medical Devices Unit
The measured.
The main drafters of this standard. Zou Yuan, Zhang Zhiyong, Zhang Rongchang.
Medical X-ray image intensifier television system
General technical conditions
1 Scope
This standard specifies the terms and definitions, requirements and test methods related to medical X-ray image intensifier television system.
This standard applies to the use of medical X-ray image intensifiers for medical X-ray image intensifier television system for X-ray fluoroscopy
(Hereinafter referred to as television system, except in Chapter 3).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB/T 10149-1988 X-ray equipment for medical terminology and symbols
YY/T 0291-2007 medical X-ray equipment environmental requirements and test methods
3 Terms and Definitions
GB/T 10149 and as defined in the following terms and definitions apply to this document.
3.1
X-ray image intensifier television system X-rayimageintensifierTVsystem
X-ray image intensifier, an optical camera, the image display system of the X-ray pattern can be converted into the corresponding visible
Imaging system.
Note 1. On the physical implementation of the circuit component analog signal processing can be installed in the camera to be installed in the video display system.
3.2
Automatic brightness control automaticbrightnesscontrol; ABC
When the thickness of the different parts of the patient or of different irradiation, to obtain a constant monitor measures the brightness of the image taken.
3.3
Image brightness stabilization signal imagebrightnessstabilitysignal; IBS signal
X-ray image intensifier television system for controlling the output of the X-ray generator, the X-ray imaging system in different parts of the patient
X-ray image intensifier output screen brightness or change the monitor screen brightness control signal is obtained when the irradiation position or a different thickness.
3.4
The focal plane distance focalspottoentranceplanedistance
X-ray tube focus to the X-ray image intensifier device from the plane of incidence.
Unit mm.
3.5
Entrancefieldsize entrance field size
For the X-ray image intensifier television system, X-ray image intensifier entrance surface at a predetermined distance below the focal plane can be used to transmit X
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