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YY/T 0744-2018: Particular specifications for mobile C-arm X-ray equipment
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
Replacing YY/T 0744-2009
Special technical conditions for mobile C-arm X-ray machine
Released on.2018-01-19
2019-01-01 Implementation
Released by the State Food and Drug Administration
Special technical conditions for mobile C-arm X-ray machine
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements of mobile C-arm X-ray machine (hereinafter referred to as C-arm X-ray machine).
Summation test method.
This standard applies to mobile X-ray machines with C-arm mechanical support devices, which are mainly used for surgical operations in medical and health institutions.
Locating and checking in. This standard does not apply to C-arm X-ray machines with a maximum focus-image-receiver distance (SID) of less than 60cm.
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 undated references, the latest edition (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 of Diagnostic X-ray Generators
GB 9706.11-1997 Medical electrical equipment Part 2.Special requirements for the safety of medical diagnostic X-ray source assemblies and X-ray tube assemblies
GB 9706.12-1997 Medical Electrical Equipment Part 1.General Requirements for Safety 3.Parallel Standard Diagnostic X-ray Equipment
General requirements for radiation protection
GB 9706.14-1997 Medical Electrical Equipment Part 2.Special Requirements for Safety of Auxiliary Equipment of X-ray Equipment
GB 9706.15-2008 Medical Electrical Equipment Part 1-1.General Requirements for Safety Collateral Standard. Safety of Medical Electrical Systems
Require
GB 9706.23-2005 Medical Electrical Equipment Part 2-43.Special Requirements for the Safety of Interventional X-ray Equipment
GB/T 10149 Terms and Symbols of Medical X-ray Equipment
GB/T 10151 Specifications for high-voltage cable plugs and sockets for medical diagnostic X-ray equipment
YY 0076-1992 Technical conditions for the classification of coatings made of metals
YY/T 0106-2008 General technical conditions for medical diagnostic X-ray machines
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
YY 0505 Medical Electrical Equipment Part 1-2.Parallel Standard for General Requirements for Safety. Electromagnetic Compatibility Requirements and Tests
IEC 61910-1.2014 Radiation dose documentation for medical electrical equipment Part 1.Radiation dose structuring for photographic and fluoroscopy equipment
3 Terms and Definitions
GB/T 10149 and the following terms and definitions apply to this document.
3.1
fluoroscopyspotimage
An image obtained by superimposing multiple frames of fluoroscopic images collected (has a higher signal-to-noise ratio than ordinary fluoroscopic images).
3.2
A digital image processing method for subtracting fluoroscopic sequence images.
3.3
Digital image processing method for subtraction of photographic sequence images.
Note 1.Compared with "X-ray image subtraction", "photographic image subtraction" has a higher X-ray dose and a higher quality of the subtracted image.
Note 2."Digital subtraction" includes "photographic image subtraction" and "fluoroscopy image subtraction", which have different clinical applications.
Note 3."Digital Subtraction Angiography (DSA)" refers to the application of "digital subtraction" in vascular imaging, usually using "photographic image subtraction".
3.4
After the device is powered off during fluoroscopy, the system is powered back on to a time when the fluoroscopy operation can be performed.
3.5
imagingtime
The time from when the X-rays are generated until the first image is displayed on the screen.
3.6
The time required from the first fluoroscopic image to a stable image during automatic brightness control.
4 Classification and composition
4.1 Classification
Classified by product structure, it belongs to mobile equipment.
According to the product image receiver can be divided into. C-arm X-ray machine with image intensifier (hereinafter referred to as image intensifier system),
Digital flat-panel detector-shaped arm X-ray machine (hereinafter referred to as flat-panel detector system).
4.2 Composition
The C-arm X-ray machine should have at least the following main components.
a) X-ray generator;
b) Mobile C-arm frame;
c) X-ray imaging system.
5 Requirements
5.1 Working conditions
5.1.1 Environmental conditions
Unless otherwise specified, the working environmental conditions of the C-arm X-ray machine shall meet.
a) Ambient temperature. 10℃~40℃;
b) Relative humidity. 30%~75%;
c) Atmospheric pressure. 700hPa~1060hPa.
5.1.2 Power Conditions
The manufacturer shall describe the power supply conditions used by the product in the accompanying documents, and the working power supply conditions shall meet.
a) Power supply voltage and number of phases. specified by the manufacturer, the network voltage fluctuation should not exceed ±10% of the nominal value;
b) Power frequency. 50Hz±1Hz;
c) Power supply resistance. specified by the manufacturer, but should meet the requirements of Table 101 in 10.2.2a) of GB 9706.3-2000;
d) Power capacity. specified by the manufacturer.
5.2 Electric power
5.2.1 Maximum output electrical power
C-arm X-ray machines shall specify the X-ray tube voltage and X-ray tube voltage that result in maximum output electrical power in fluoroscopy and/or photography modes
The corresponding combination of streams.
5.2.2 Nominal electrical power
It should be stipulated that when the loading time is 0.1s and the X-ray tube voltage is 100kV, the X-ray generator can provide in kilowatts (kW).
The maximum constant electrical power output in units is given as the nominal electrical power. If this value cannot be preselected, use the X closest to 100kV
The ray tube voltage value and the closest loading time value, but not shorter than 0.1s.
The nominal electrical power should be given with a combination of X-ray tube voltage and X-ray tube current and loading time.
5.3 Loading factors and controls
5.3.1 X-ray tube voltage
The X-ray tube voltage should meet the following requirements.
a) The manufacturer shall specify the X-ray tube voltage adjustment range and adjustment method;
b) The manufacturer shall specify the deviation of the X-ray tube voltage value, but shall at least meet the requirements of 50.103.1 in GB 9706.3-2000.
5.3.2 X-ray tube current
The X-ray tube current should meet the following requirements.
a) The manufacturer shall specify the X-ray tube current adjustment range and adjustment method in continuous and highest frame rate pulsed fluoroscopy mode;
b) The manufacturer shall specify the deviation of the current value of the X-ray tube, but shall at least meet the requirements of 50.103.2 in GB 9706.3-2000.
5.3.3 Loading time
The loading time should meet the following requirements.
a) If the loading time display is provided and the single-frame photography function is provided, the manufacturer shall specify the loading time adjustment range and
adjustment method;
b) The manufacturer shall specify the deviation of the loading time value, but shall at least meet the requirements of 50.103.3 in GB 9706.3-2000.
5.3.4 Current time product
If the current time product display is provided, the current time product shall meet the following requirements.
a) The manufacturer shall specify the current time product adjustment range and adjustment method;
b) The manufacturer shall specify the deviation of the current time product, but shall at least meet the requirements of 50.103.4 in GB 9706.3-2000.
5.3.5 Overload protection
The overload prevention of the C-arm X-ray machine shall meet the following requirements.
a) There should be anti-overload measures to ensure that the selection of the loading factor will not exceed the rated capacity of the X-ray tube. should comply with the instruction manual
The maximum load factor combination given.
b) If overloaded, the system should automatically protect and stop radiation, and there is a warning message.
c) If the C-arm X-ray machine has fluoroscopy-guided interventional operations, there should be an indication of the heat capacity or temperature of the X-ray tube assembly.
5.4 Imaging performance
5.4.1 Spatial resolution
The spatial resolution should meet the following requirements.
a) For image intensifier systems, the manufacturer shall specify the nominal field of incidence spatial resolution in fluoroscopic, fluoroscopic spot and photographic modes,
However, it should not be less than the specified value in Table 1;
b) For flat panel detector systems, the manufacturer shall specify the spatial resolution and corresponding field of view size in perspective and photographic modes.
5.4.2 Low contrast resolution
The low-contrast resolution in the nominal input field mode shall meet the following requirements.
a) The low-contrast resolution of the perspective mode should not be greater than 5.6%;
b) The low-contrast resolution of fluoroscopic and photographic modes should not be greater than 4%.
5.4.3 Dynamic range
The spatial resolution should meet the following requirements.
a) For image intensifier systems, in the nominal field of view mode, the number of discernible dynamic order wedges for fluoroscopy should not be less than 12, and the fluoroscopy point slices and
The number of discernible dynamic order wedges for photography should not be less than 13;
b) For the flat panel detector system, in the nominal field of view mode, the number of discernible dynamic order wedges of perspective should not be less than 14, and the discernible number of photographic
The number of different dynamic order wedges should not be less than 16.
5.4.4 Image uniformity of flat panel detector system
The manufacturer shall specify the maximum image uniformity for C-arm X-ray machines and the SID and loading factors used. unless the manufacturer
It is otherwise stated that the ratio of the standard deviation R of the gray value of the specified sampling point of the image to the mean value Vm of the gray value of the specified sampling point should not be greater than 2.2%, see
(1).
5.4.5 Image Brightness Stability
If the product has an automatic perspective function, the image brightness stability of the C-arm X-ray machine should not be greater than 15%.
5.4.6 Pulse fluoroscopy
The C-arm X-ray machine should provide the function of pulse fluoroscopy, and the frame rate should be adjustable.
5.4.7 Imaging time
The imaging time should meet the following requirements.
a) The manufacturer should specify the fluoroscopic imaging time, but it should not be greater than 1s;
b) The manufacturer shall specify the imaging time of the photography mode, but it should not be greater than 5s.
5.4.8 Perspective image stabilization time
The manufacturer shall specify the fluoroscopic image stabilization time under continuous and highest pulse fluoroscopic frame rate, but shall not exceed 2s.
5.4.9 Fluoroscopy Recovery Time
The fluoroscopy recovery time should not exceed 5min.
5.4.10 Perspective performance during network transmission
When pivoting, such as selecting network transport, it should not affect the perspective.
5.4.11 Artifacts
No artifacts affecting clinical application.
5.4.12 Digital Subtraction Imaging Performance
5.4.12.1 Photographic Image Subtraction Imaging Performance
If the C-arm X-ray machine has the photographic image subtraction imaging function, it should meet the following requirements.
a) The manufacturer shall specify the dynamic range, but at least the thickest one vessel simulation component is visible in all steps;
b) The manufacturer shall specify the contrast sensitivity, but the 0.1mm vessel simulation component shall be visible at least in the 0.8mm copper step;
c) When the two images of the fixed object have the same spatial coordinate characteristics, there should be no misregistration artifacts.
5.4.12.2 Fluoroscopy Image Subtraction Imaging Performance
If the C-arm X-ray machine has the function of fluoroscopic image subtraction imaging, it should meet the following requirements.
a) The manufacturer shall specify the contrast sensitivity, but the 0.4mm vessel simulation component shall be visible at least in the 0.8mm copper step.
b) When the two images of the fixed object have the same spatial coordinate characteristics, there should be no misregistration artifacts.
5.4.13 3D Imaging
5.4.13.1 3D Acquisition Parameters
The manufacturer shall specify the three-dimensional acquisition angle, the number of acquired image frames and the size of the reconstruction area, where the acquisition angle should not be less than 180°.
5.4.13.2 3D imaging spatial resolution
The manufacturer shall specify the cross-sectional spatial resolution of the 3D imaging. If not specified, the high contrast mode shall be able to see at least 1.3mm.
4 independent holes, the low contrast mode should be able to see at least 4 independent holes of 0.9mm.
Note. See 5.5.2 for dose requirements for high or low contrast mode of 3D imaging.
5.4.13.3 3D Image Artifacts
There should be no artifacts affecting clinical application.
5.5 Radiation Safety
5.5.1 Dosage indication
The dose indication of the C-arm X-ray machine shall meet the following requirements.
a) The instruction manual should specify the measurement reference point and calibration information of the dose indication value.
b) During the fluoroscopy process, the air kerma rate shall be continuously indicated in milli-Gy/min (mGy/min), refreshed at least once per second,
And the indication should be clearly visible in the normal working position.
c) Since the last reset setting, the cumulative value of air kerma generated by all perspective and photography should be in milli-Ge (mGy)
Continuous indicati...