YY/T 0741-2018 PDF English
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| YY/T 0741-2018 | English | 150 |
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Particular Specifications for Digital X-Ray Radiography System
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| YY/T 0741-2009 | English | 85 |
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General specification for digital medical X-ray radiography system
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YY/T 0741-2018: Particular Specifications for Digital X-Ray Radiography System---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0741-2018
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.50
C 43
Replacing YY/T 0741-2009
Particular Specifications for
Digital X-Ray Radiography System
Issued on. SEPTEMBER 28, 2018
Implemented on. OCTOBER 01, 2019
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 6
4 System Composition... 8
5 Requirements... 8
6 Test Methods... 15
Appendix A (Normative) Test Arrangement... 23
Appendix B (Informative) Test Phantom... 24
Appendix C (Informative) Drafting Explanation of Some Clauses... 27
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard replaced YY/T 0741-2009 General Specifications for Digital Medical X-
Ray Radiography System. Compared with YY/T 0741-2009, this Standard has the
major technical parameter changes as follows.
--- Modify the standard name from General Specifications for Digital Medical X-Ray
Radiography System to Particular Specifications for Digital X-Ray Radiography
System;
--- Modify the description of the Clause 4 System Composition;
--- Modify 5.3.6 requirements and test methods for automatic exposure control;
--- Modify 5.4 limits and test methods of some subclauses of imaging performance;
--- Modify 5.5 description of some subclause requirements of mechanical device
performance;
--- Modify 5.6.2 information management, 5.6.3 requirements and test methods of
imaging time;
--- Add 5.3.8 dose area product indication, 5.3.9 requirements and test methods of
pediatric photography;
--- Add 5.4.3 dynamic range, 5.4.8 (long bone) image stitching performance, 5.4.9
detector calibration and stability test, 5.4.10 requirements and test methods of
quantum detection efficiency;
--- Delete 5.6.4 requirements and test methods of preview time;
--- Add description of the integrated test card (see Appendix B).
Please note some contents of this document may involve patents. The issuing
organization of this document shall not assume the responsibility for identifying these
patents.
This Standard was proposed by National Medical Products Administration.
This Standard shall be under the jurisdiction of Subcommittee on Medical X-Ray
Equipment and Appliance of National Technical Committee for Standardization of
Medical Electrical Equipment (SAC/TC 10/SC 1).
Drafting organizations of this Standard. Liaoning Medical Device Test Institute;
Shanghai Siemens Medical Devices Co., Ltd.; Shanghai United Imaging Healthcare
Technology Co., Ltd.; and Derunte Medical Technology (Wuhan) Co., Ltd.
Chief drafting staffs of this Standard. Wang Yanan, Liu Congzhi, Xiang Jun, Zhang
Junyi, Zhang Yujing, Sun Zhiyong, Zhang Yong, and Zou Yuan.
The historical edition replaced by this Standard is as follows.
--- YY/T 0741-2009.
Particular Specifications for
Digital X-Ray Radiography System
1 Scope
This Standard specifies the terms and definitions, system composition, requirements
and test methods for digital X-ray radiography system (hereinafter referred to as DR
system).
This Standard is applicable to the DR system for general X-ray photography. It includes
but not limited to DR systems that use line scan or area scan detectors, such as.
--- DR system using flat panel detector (FPD);
--- DR system using area array CCD detector;
--- DR system using line array scanning CCD detector;
--- DR system using CMOS detector, etc.
Corresponding to the DR system using more than one digital X-ray image detector,
this Standard is applicable to each digital X-ray image detector and the X-ray
generating device used in its imaging.
This Standard is not applicable to system using X-ray image intensifier, system using
imaging device of image plate for X-ray photography, mammary X-ray equipment,
dental X-ray equipment, computed tomography equipment, mobile DR system.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
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
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in Normative
References and the following apply.
3.1 Digital radiography system
It uses digital X-ray image detector technology to realize the X-ray photography;
generally, it consists of X-ray generating device, digital X-ray imaging device, and
ancillary equipment.
3.4 Imaging time
The time, from the exposure to the screen displaying, required for the normal image
satisfying the diagnostic needs.
3.5 Information management
Software measures for managing the patient information, such as appointments,
registrations, modifications, deletions, queries, statistics, backup management, etc.
3.6 Low contrast resolution
Under specified measurement conditions, the lowest contrast details between
specified shape and area that can be distinguished from a uniform background
condition, expressed in %.
3.10 Effect image area
Maximum effective area for detector imaging.
3.11 Artifact
A structure that is clearly visible on an image. It neither reflect the internal structure of
the object, nor can it be explained by noise or system modulation transfer functions.
3.12 Erasure thoroughness
After the previous image signal is read, part of all of the previous image generated in
the subsequent image due to incomplete signal removal.
4 System Composition
See Figure 1 for DR system composition.
5 Requirements
5.1 Working conditions
5.1.1 Environmental conditions
Unless otherwise specified, the working and environmental conditions of the DR
system shall satisfy as follows.
5.1.2 Power supply conditions
The operating power supply conditions of the DR system shall satisfy as follows.
5.2 Electric power
5.2.1 Maximum output electric power
It shall be specified in the product technical requirements for the corresponding
combination between voltage and current of X-ray tube with maximum output electric
power.
5.3 Loading factors and control
5.3.1 X-ray tube voltage
The X-ray tube voltage shall meet the following requirements.
5.3.3 Loading time
If there is an indication for loading time, it shall meet the following requirements.
a) It shall be specified in product technical requirements for adjustment range and
5.3.5 Anti-overload
The DR system shall take the anti-overload measures, ensuring that the selection of
loading factor shall not exceed the rated capacity of the X-ray tube. It shall satisfy the
maximum loading factor combination given in the instruction manual.
5.3.6 Automatic exposure control
The DR system shall be equipped with Automatic Exposure Control (AEC) function.
The repeatability of the radiation output in the AEC mode shall satisfy the coefficient of
variation for the air kerma measurement value no greater than 0.05.
5.4.4 Flat uniform
The manufacturer shall specify the maximum flat uniformity of DR, the used SID, and
loading factor. Unless otherwise is specified by the manufacturer, it is specified by the
image that the ratio between the standard deviation of the gray value on sampling point
R and the mean value of the gray value on the sampling point Vm shall be no greater
than 2.5%. Namely, formula (2).
5.6 Network and software
5.6.1 Network communication
It shall conform to the DICOM3.0 standard; the manufacturer shall provide a
declaration of conformity for DICOM3.0 standard in accompanying file.
5.6.2 Information management
5.6.3 Imaging time
The imaging time shall be no more than 12s.
5.7 Plug and socket of high voltage cable
Unless otherwise specified, it shall meet the requirements for relevant type, basic
dimension, marking, connection specified in GB/T 10151.
5.8 Appearance
The appearance of the DR system shall be neat and beautiful; the surface shall be
smooth with uniform luster; free of scars, cracks, and the like defects.
5.9 Environmental test
It shall meet the requirement of YY/T 0291.The initial, intermediate or final test items
shall include at least the contents of 5.4.1, 5.4.2, 5.4.3, 5.5.4.
6 Test Methods
6.1 Test conditions
6.1.1 Environmental conditions
It shall conform to the provisions of 5.1.1.
6.1.2 Power supply conditions
The test power supply conditions are as follows.
6.2 Electric power
6.2.1 Maximum output electric power
The DR system operating in an intermittent mode is loaded in the combination with the
loading factors that cause the maximum output electric power; then observe whether
there is an abnormality.
6.3 Loading factor and control
6.3.1 X-ray tube voltage
It shall be performed as per the following methods.
6.3.3 Loading time
It shall be performed as per the following methods.
6.3.4 Current time product
It shall be performed as per the following methods.
6.3.5 Anti-overload
It shall be performed as per the following methods.
Adjust the parameters of the DR system to the maximum load factor combination value
specified in the instruction manual. When readjust any loading factor to the adjacent
increase shift, the loading factor condition shall not be increased any more or the DR
system is in the overload state. For the DR system with continuous adjustment of the
X-ray tube voltage, when the operating voltage value of the anti-overload device is
higher than the maximum X-ray tube voltage value (but not exceeding 5kV) specified
in the instruction manual, it shall not be exposed and/or alarmed.
6.3.7 Correspondence between X-ray field and image receiving surface
It shall be performed as per the following methods.
6.3.8 Dose area product indication
It shall be performed as per the following methods.
Place the X-ray dosimeter detector in an appropriate position in the X-ray beam, such
as on the image receiver surface or bed surface. Adjust the X-ray filed dimension to
15cm×15cm or other proper dimensions. Take photograph to dose area product that is
displayed by the equipment is greater than 5µGy•m2; multiply the measured dose value
by the ray filed area at the air kerma dosimeter detector. It can also be measured
directly by the dose area product meter. Calculate the error between displayed value
and the measured value.
6.3.9 Pediatric photography requirements
Actual operation and inspection.
6.4 Imaging performance
6.4.1 Spatial resolution
Test and arrange the multi-function test card shown in Figure B.1 according to Figure
A.1.Adjust SID to be the normal clinical use distance; set the visual field of the image
to be the maximum effect image area of the plate; select the typically clinical protocol
specified by the manufacturer; manually set the X-ray tube voltage to be 75kV±7kV;
AEC automatic exposure. If required, adjust the window width and position; record the
spatial resolution value and corresponding loading factor combination.
6.4.10 Quantum detection efficiency
Check the manufacturer’s accompanying file.
6.5 Performance of mechanical device
6.5.1 Scope of mechanical motion
In practice, measure the range of rotation angle by the angle gauge; the minimum
division scale of the angle gauge is no greater than 0.5°. The range of motion the
longitudinal, lateral, and vertical directions is measured by a length gauge.
6.5.2 Length indication value
In practice, measure by the length gauge.
6.5.3 Angle indication value
In practice, measure by the angle gauge.
6.5.4 Braking
In practice, measure by a dynamometer.
6.5.5 Load bearing
The patient support device is in a horizontal state and in most unfavorable position at
work; uniformly distribute 135kg load on the 168cm×37.5cm support surface for 1min;
observe whether it can work normally.
For pedals and chairs, uniformly distribute 135kg load on the 0.1m2 support surface
for 1min; observe whether it can work normally.
6.7 Plug and socket of high voltage cable
In case when the manufacturer specified otherwise, inspection according to the
method specified by the manufacturer; otherwise, inspect according to the relevant
type, basic dimension, marking, connection specified in GB/T 10151.
6.8 Appearance
Visual examination.
6.9 Environmental test
The environmental test shall be performed as per the provisions of YY/T 0291.
6.10 Safety requirements
It shall be performed as per the provisions of GB 9706.1, GB 9706.3, GB 9706.11, GB
9706.12, GB 9706.14, GB 9706.15 and YY 0505.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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