YY/T 0741-2018 English PDF (YYT0741-2018)

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YY/T 0741-2018: Particular specifications for digital X-ray radiography system
YY/T 0741-2018
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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
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
GB 9706.14 Medical Electrical Equipment - Part 2: Particular Requirements for the
Safety of Associated Equipment of X-Ray Equipment
GB 9706.15 Medical Electrical Equipment - Part 1: General Requirements for
Safety - 1. Collateral Standard: Safety Requirements for Medical Electrical
Systems
GB/T 10151 Medical Diagnostic X-Ray Equipment - Specifications for High
Voltage Cable Plugs and Sockets
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 Standards: Electromagnetic Compatibility Requirements and Tests
DICOM 3.0 (all parts) Digital Imaging and Communications in Medicine (Edition III)
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.
3.2 Digital X-ray imaging device
The system that uses digital X-ray image detector; consists of the subsystem that can
be able to perform the image processing, displaying, printing or storing; provides the
projecting images in a digital format.
3.3 Digital X-ray image detector
The converter, after spatial sampling of X-ray by a line array or matrix pixel structure,
shall be less than 3mm;
c) In the image stitching function, the manual adjustment function shall be provided;
d) On the image after stitching, the stitching position shall be marked.
5.4.9 Detector calibration and stability test
a) The DR system shall have the function of supporting the user to perform
conventional detector calibration;
b) The manufacturer shall provide the content and frequency of the stability test in
accompanying file; the DR system shall provide a stability test procedure.
5.4.10 Quantum detection efficiency
The manufacture shall give, in the accompanying file, the quantum detection efficiency
value of the used detector at the indicated standard radiation quality, irradiation dose
and different spatial frequencies (at least 0.5lp/mm, 1.0lp/mm, 1.5lp/mm, 2.0lp/mm,
2.5lp/mm up to slightly lower than the maximum frequency of NYQUIST sampling
frequency).
5.5 Performance of mechanical device
5.5.1 Mechanical motion range
It shall be specified in the product technical requirements for the rotation angle range
of electromechanical auxiliary device, and motion range in the longitudinal, transverse
and vertical directions, and their deviations.
5.5.2 Length indication value
The deviation between the length indication value and the actual value shall be within
the range of ±5% indication value.
5.5.3 Angle indication value
The deviation between the angle indication value and the actual value shall be within
the range of ±1 minimum division value.
5.5.4 Braking
The linear motion part of the mechanical device shall have a braking device. After the
network power is turned off or the emergency stop switch is pressed, the motion parts
shall be braked. (Except that the suspension is required to be balanced without the
need for braking) the braking force shall be no less than 100N. The braking force of
the rotating parts shall be specified by the product technical requirements.
5.10 Safety
It shall meet the requirements of GB 9706.1, GB 9706.3, GB 9706.11, GB 9706.12,
GB 9706.14, GB 9706.15 and YY 0505.
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:
a) The network voltage and the number of phases shall conform to the provisions
of product technical requirements; the network voltage fluctuation shall not
exceed ±10% nominal value;
b) Power supply frequency: 50Hz±1Hz;
c) The power supply resistance shall conform to the provisions of 5.1.2 c);
d) The power supply capacity shall conform to the provisions of 5.1.2 d).
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.
6.2.2 Nominal electric power
The DR system operating in an intermittent mode is loaded in the combination with X-
ray tube voltage, X-ray tube current, loading time that cause the nominal 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:
Under the AEC mode, the repeatability of radiation output shall be perfor...