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(General technical requirements for X-ray computed tomography equipment)
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General specifications for X-ray equipment for computer tomography
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Basic data | Standard ID | YY/T 0310-2025 (YY/T0310-2025) | | Description (Translated English) | (General technical requirements for X-ray computed tomography equipment) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2026-07-01 | | Older Standard (superseded by this standard) | YY/T 0310-2015, YY/T 1417-2016 | | Issuing agency(ies) | National Medical Products Administration | YY/T 0310-2015: General specifications for X-ray equipment for computer tomography---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 equipment for computed tomography
ICS 11.040.50
C43
People's Republic of China pharmaceutical industry standards
Replacing YY 0310-2005
X-ray computer tomography equipment general technical conditions
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces YY 0310-2005 "X-ray computer tomography equipment general technical conditions."
This standard YY 0310-2005 compared to the main technical changes are as follows.
--- Modify the scope description, it includes providing image data for radiation therapy planning CT scanning device;
--- Increasing the normative references YY 0505 and YY/T 0708 two standards;
--- Demanding environmental conditions adjusted to the conditions required by GB 9706.1;
--- Increased gantry rotation speed requirements;
--- Modify the original scan time exposure time;
--- Remove the indicating instrument (2005 Version 5.5.5);
--- Increasing the radiation treatment planning (RTP) requirements and test methods.
This standard was proposed by the China Food and Drug Administration.
This standard by the National Technical Committee of Standardization for medical electrical equipment and medical X-ray appliances Technical Committee (SAC/TC10/SC1)
Centralized.
This standard was drafted. Liaoning Medical Device Control, Hang Wei GE Medical Systems Limited.
The main drafters of this standard. Wang Jianjun, Hao Suli, Mu Li, Han Qiang, Wang Shoumin.
This standard replaces the standards previously issued as follows.
--- YY 0310-1998, YY 0310-2005.
X-ray computer tomography equipment general technical conditions
1 Scope
This standard specifies the X-ray computed tomography apparatus (hereinafter referred to as CT scanning device) terms and definitions, classification, composition, to
Sum test methods.
This standard applies to CT scanning device, including the provision of image data into radiotherapy planning CT scanning device.
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 Medical Electrical Equipment Part 1. General requirements for safety
GB 9706.11 Medical electrical equipment - Part II. diagnostic X-ray source assemblies and X-ray tube assembly requirements for the safety
GB 9706.12 Medical electrical equipment Part 1. General requirements for safety Collateral standard diagnostic X-ray equipment for radiation protection.
General requirements
GB 9706.14 Medical electrical equipment - Part 2. Safety ancillary equipment requirements for 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 9706.18 Medical electrical equipment - Part 2. X-ray computer tomography equipment requirements for the safety
GB/T 10149 X-ray equipment for medical terminology and symbols
GB/T 10151 for medical X-ray equipment voltage cable plug and socket
Evaluation of GB/T 19042.5-2006 medical imaging departments and routine testing - Part 3-5. X-ray computed tomography provided
Preparation of image performance acceptance test
Plating classification requirements of metal parts YY 0076-1992
YY/T 0291 medical X-ray equipment environmental requirements and test methods
YY 0505 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests
Safety requirements for medical electrical equipment YY 0637 radiation treatment planning system
YY/T 0708 Medical electrical equipment - Part 1-4. General requirements for safety Collateral Standard. Programmable Electrical Medical Systems
3 Terms and Definitions
GB/T 10149, GB 9706.18, GB/T 19042.5-2006 and YY 0637 terms and definitions apply to this document defined.
4 Classification and composition
4.1 Classification
Security classification should be consistent with GB 9706.1 classification requirements.
4.2 Composition
CT scanning device consists of the following components.
a) scanner;
b) X-ray generator;
c) the patient support;
d) console;
e) a computer image processing system.
When necessary, should indicate to offer options.
5 Requirements
5.1 Working conditions
5.1.1 Environmental conditions
Unless otherwise noted, CT scanning device in the following environmental conditions should be able to work properly.
a) Ambient temperature range. 10 ℃ ~ 40 ℃;
b) Relative humidity range. 30% to 75%;
c) Atmospheric pressure range. 700hPa ~ 1060hPa.
5.1.2 supply conditions
Equipment should at least be able to work under the following conditions.
Allow range a) rated supply voltage value is 90% to 110%;
b) the power frequency is 50Hz, frequency tolerance of ± 1Hz;
c) the power supply capacity and resistance specified by the product standard.
5.2 Performance
5.2.1 image noise
It should not exceed 0.35% (center dose not more than 40mGy).
Uniformity 5.2.2 CT values
CT value uniformity of water does not exceed ± 4HU.
5.2.3 CT accuracy values
Air. -1000HU ± 10HU; water. 0HU ± 4HU.
5.2.4 spatial resolution (high contrast resolution)
You should choose a typical operating conditions of CT head and body, as well as the highest spatial resolution of CT operating conditions.
Requirements and test methods for spatial resolution product standard shall be defined.
5.2.5 Low contrast resolution
You should choose a typical operating conditions of CT head and body.
Requirements and test methods for low-contrast resolution product standard shall be defined.
5.2.6 operating noise
Unless otherwise specified, shall not exceed 70dB (A-weighted).
5.2.7 Artifacts
CT images should not have artifacts.
5.2.8 Section thickness
Product standard shall specify the nominal value of the slice thickness. Deviation of the measured value and the nominal value of the slice thickness should not exceed the values listed below.
--- Larger than 2mm slice thickness. ± 1.0mm;
--- Slice thickness of 1mm ~ 2mm of. ± 50%;
--- Of less than 1mm slice thickness. ± 0.5mm.
5.3 gantry
Gantry should have the following functions and meet the requirements.
a) has a tilt function of CT scanning device, before and after its deal with the gantry tilt angle gives an indication of the inclination angle of deviation should not
More than ± 2 °;
b) be at least sagittal plane cross section of the positioning lights at the narrowest section of the nominal layer thickness, the light field and the center layer cut
Consistency should be the center piece in the 2mm;
c) should have at least two kinds of anteroposterior and lateral scout scan function;
d) the rotational speed of the sub-file should set the value of the rotational speed of the sub-file product standard should specify stall deviation shall not exceed ± 5%. in case
Rotating faster than 0.3s/360 °, the deviation from the prescribed product standards.
5.4 patient support
Patient support shall have the following functions and meet the requirements.
a) with height adjustable patient support function, height adjustment range of at least half the diameter of the opening of the gantry;
b) patient support surface of the bed in the horizontal movement range should be not less than 1000mm;
c) positioning the patient support should meet GB/T 19042.5-2006 5.1 requirements.
5.5 X-ray generator
5.5.1 X-ray tube voltage
Should have the X-ray tube voltage preset function, product standard deviation shall be specified preset value X-ray tube voltage, tube voltage should not
More than ± 10%.
5.5.2 X-ray tube current
X-ray tube current profile settings should be divided, divide the value of X-ray tube current profile product standard should specify that the deviation of the file should not exceed
± 20%.
5.5.3 Exposure time
Axial scan exposure time should be set binning, binning value of the exposure time product standard shall be defined. Unless otherwise specified, an axial scan,
Helical scan exposure time deviation shall not exceed ± 10%.
5.5.4 high-voltage cable plug and socket
Unless otherwise specified, shall comply with GB/T 10151 concerning Types and basic dimensions, marking, requirements of the connection.
5.6 software features
Where applicable, the product standard shall specify the operating software.
5.7 CT scanning device for providing radiation treatment planning (RTP) of an image requires
5.7.1 Positioning the patient support surface
5.7.1.1 Overview
Accompanying documents should indicate with respect to the layer plane of the surface of the stent patient positioning procedures, so that the long axis of the patient support surface energy along
Within the maximum scanning range Z axis vertical and horizontal positioning.
5.7.1.2 patient support positioned on the vertical plane (tilt)
Locator request with respect to the horizontal positioning accuracy of less than or equal to ± 0.5 ° (Figure 1).
Locator request after installation, no load and measure the surface of the stent patients when fully retracted.
Explanation.
Z --- Z axis;
Z '--- patient support shaft;
Y --- Y axis;
t --- tilt angle;
1 --- gantry;
2 --- stent patients.
Positioning a patient support in the vertical plane of FIG.
5.7.1.3 Positioning of the patient support in a horizontal plane
Positioning the patient support in the horizontal plane shall meet the following requirements.
Horizontal patient support surface a) positioning request to move to the layer plane perpendicular to the axis of the X-axis error is within ± 1 °;
b) positioning procedures shall require the centerline of the stent surface to the front end of the patient markers (M1) and at 1m from the front end (M2).
Deviation and sagittal centerline positioning lights labeled Z axis should be located in the M1 and M2, measured at the scanning plane. d1 and d2 are not
Should be more than 2mm (see Fig. 2). If the sagittal orientation lighting can not be extended to the scan plane, should be measured in the external positioning lamp position.
Explanation.
Z --- Z axis;
Z '--- patient support shaft;
X --- X axis;
1 --- gantry;
M1, M2 --- marking on the patient support surface;
d1, d2 --- from the marking point to the Z axis distance.
Figure 2 Location horizontal plane in the Z-axis of the patient support
5.7.2 The surface of the stent patients
Patients should be flat surface of the stent, or a random document describing the surface can become flat attachment, and make it available.
Patient support should allow the use of positioning aids treatment system.
5.7.3 Diagnosis bed sag (stiffness in patients with stent)
It should provide 40cm (typical scan length plus the amount of movement of the scanning plane) diagnostic bed sag range.
5.7.4 for patient positioning integrated positioning lights
If the positioning lights integrated in the CT scanning device, accompanying documents should confirm whether the intended use of the positioning of the lamp can be used in patients with RTP
Location.
If the integrated positioning lights intended for patient positioning in RTP, it should have the following accuracy.
Accurate axial positioning lights and other centers should be ± 1mm, ± 250mm distance in the X direction accuracy shall be ± 2mm.
Sagittal and coronal positioning lights Positioning lights should extend to the scan plane, while with respect to the accuracy of the shaft should be ± 1mm.
Tag line width (FWHM) positioned in the light of such centers should be no more than 1mm.
5.7.5 produce the typical image scanning mode RTP
Randomly generated file should specify the operating conditions for RTP typical CT image. RTP protocol is not suitable for generating images should follow
Machine file description.
For a typical CT operating conditions RTP, the document should provide random noise according to GB/T 19042.5-2006 method of measuring the average
Test Results CT value and uniformity.
5.7.6 HU value conversion
HU value of each conversion type press CT operating conditions described in 5.7.5 with respect to the measurement of water quality and the electron density values
It should be described in the ACCOMPANYING DOCUMENTS. It should at least provide air, water, one with considerable soft tissue and bone material and two kinds of quite different materials
Conversion factor.
This conversion is performed using a phantom and CT operating conditions shall be specified in the accompanying documents, the market should be able to get the upper body mold.
Random files should be stated full-field data limit and indicate whether the area has a different level of accuracy.
5.7.7 geometric precision image data
5.7.7.1 Overview
Image data should have a geometric accuracy of scanning the entire field of vision, according to the implementation 5.7.7 can meet this requirement.
Random files should be stated full-field limit of geometric precision and indicate whether the area has a different level of accuracy.
Random files should explain the basis 5.7.7.2,5.7.7.3 and 5.7.7.4 positioning validation test specification.
5.7.7.2 gantry tilt
Gantry tilt should be set at zero position, relative to the X axis and over a plane perpendicular to the surface of the bed of its diagnostic accuracy should be ± 1 °
Fewer.
Angular positioning 5.7.7.3 CT images
Reconstructed image angular positioning accuracy is crucial for the RTP in the image by positioning the object should be known geometry
verification.
Marked with the reference horizontal or vertical deviation on the 20cm distance should be less than 3mm.
Accuracy 5.7.7.4 helical scan image position z
Should verify the accuracy of the patient support and the actual position of the image z z position.
Deviation of the image position to its nominal value of z should be less than 1mm.
5.8 Appearance
Exterior CT scanner shall meet the following requirements.
Shape a) CT scanning device should be neat, attractive, flat and smooth surface, uniform color, without injury spots, cracks and other defects;
Plating b) CT scanning device shall comply with the requirements of level 2 YY 0076-1992 appearance.
5.9 Environmental Testing
Shall comply with YY/T 0291 requirements. The final test items should include at least 5.2.1,5.2.2,5.2.3,5.2.5,5.2.8 and 5.5.3.
5.10 Safety
Shall comply with GB 9706.1, GB 9706.11, GB 9706.12, GB 9706.14, GB 9706.15, GB 9706.18, YY 0505 and
YY/T 0708 requirements.
6 Test methods
6.1 Test conditions
CT scanning device to be tested under the following conditions.
a) Unless otherwise specified, all performance tests shall, under the conditions specified in 5.1 were;
b) recommended in line with the American Association of Physicists in Medicine (AAPM) standard CT phantom;
c) Unless otherwise specified, should choose a typical operating conditions of CT head and body scans.
6.2 Performance
6.2.1 image noise
Under typical head scanning conditions (recommended 10mm slice thickness) using a phantom head CTDI measurement center dose.
If the device is not 10mm slice thickness, the product standard shall specify the conversion factor of image noise.
The homogeneous medium phantom (20cm water mold) is placed in the scan field of view, and coincides with the axis of the phantom with the gantry rotation axis scanning
After the center of the image to select a diameter of about 40% of the diameter of the image region of interest, this area of CT values measured standard deviation SD, with
Formula (1) calculate the noise value N.
N =
SD
1000 × 100%
(1)
Where.
N --- image noise measurement region;
Standard deviation SD --- CT value measurement area.
Uniformity 6.2.2 CT values
6.2.1 on the image obtained from the phantom edge about 1cm at equivalent clock 3,6,9,12 o'clock choose four invigoration
Fun Zone, select a region of interest in the center of the image, the diameter of each of the regions of interest of about 10% of the diameter of the image, the center of interest
Region and outside the region of interest should not overlap. Measuring the average CT value of each region of interest, CT value of the center region of interest and a sense of external 4
The difference between the maximum value of the CT area of interest is the uniformity of the CT values.
6.2.3 CT accuracy value
6.2.1 Use the conditions and methods of phantom scans the image of each substance were measured at the center of the image material
Choose a not less than 100 pixels ROIs, measurement of the average CT value of this area is the CT value of the substances.
6.2.4 Spatial resolution
The standard recommends the following method.
The spatial resolution of the phantom is placed within the scanning field of vision, and coincides with the axis of rotation of the gantry axis of the phantom, the choice of a running group CT
Scanning conditions, and then reconstruction algorithm to reconstruct and adjust window width and position, observed through the monitor image to be able to distinguish the best orifices
The diameter shall prevail.
It may be employed modulation transfer function (MTF) of the method of spatial resolution tests.
6.2.5 Low contrast resolution
The standard recommends the following method.
The low contrast resolution phantom placed in the scanning field of vision, and coincides with the axis of rotation of the gantry axis of the phantom, the choice of a set of CT transport
Conditions to be scanned, and then the reconstruction algorithm to reconstruct and adjust window width and position, by observing the monitor to be able to distinguish the most holes
The diameter of the group shall prevail.
6.2.6 operating noise
In the fastest scan state, with a sound level meter in height from the ground 1.5m, were measured from the front of the gantry appearance, back, left and right 1m
At the operating noise, takes the maximum value.
6.2.7 Artifacts
Water was placed in the mold scanning the field of view, and phantom axis coincides with the axis of rotation of the gantry, the choice of a set of operating conditions into CT
Scan. In the window is 0, the window width CT images were observed under conditions 50HU, 100HU water mold.
6.2.8 Section thickness
The standard recommends the following method.
Slice thickness measurement phantom is placed in the scan field of view, and the axis of rotation coincides with the axis of the phantom scans, CT setting run
condition. Set different nominal slice thickness and scanned in the CT image is formed, the window width is adjusted to narrowest position,
Window level adjusted to just the background disappears, then the value of CT window level is the background. Then the above-described processing on the image formed by each inclined surface,
To determine the maximum value CT. With the maximum value of CT CT value of the background and divided by 2 to obtain the value of half of the maximum CT value measured
Width is the thickness (FWHM), taking the average of the results, that is, the slice thickness.
For helical scan mode, the slice thickness test methods shall be defined in the product standard.
6.3 gantry
The standard recommends the following method.
a) First, the gantry tilt angle adjusted to zero, then the gantry forward after two tilted to any angle and maximum angle,
With angle measurement;
b) the head of the bed raised to the scanning position, the edge length shorter than 15cm of film placed in the beam spread on the bed panel positioning of the lamp.
Along the center line of the beam on the film with a needle pierced with holes. Setting the narrowest nominal slice thickness as the fixed layer scanning (the tube
Anteroposterior). From the film is the distance measured positioning accuracy of the lamp;
c) anteroposterior and lateral respectively, for scanning, sight of the rest;
d) shall be tested at the highest rotation speed, minimum rotational speed and the rotational speed of the middle stall condition.
6.4 patient support
In the following way.
a) will be adjusted to the height of the patient support of maximum and minimum, respectively, measure and calculate the adjustment range with a ruler at the same basis;
b) The patient support surface of the bed to move in both directions extreme positions, with the scale to measure the range of motion;
c) according to GB/T 19042.5-2006 methods specified in 5.1.
6.5 X-ray generator
6.5.1 X-ray tube voltage
It should be the minimum X-ray tube voltage of the highest (in the state (the highest tube current conditions of the state) the highest X-ray tube voltage
Under current conditions) and a middle gear X-ray tube voltage (if any) under test conditions.
6.5.2 X-ray tube current
It should be the minimum X-ray tube current of the highest (in the state (the highest tube voltage conditions of the state) maximum X-ray tube current
Tested under voltage conditions) and middle profile X-ray tube current (if any) conditions.
6.5.3 Exposure time
It should be the longest exposure time, the shortest exposure time and the middle of a file exposure time under the conditions tested.
6.5.4 high-voltage cables and plugs, sockets
The method according to GB/T 10151 stipulated performed.
6.6 software features
Practical observation.
6.7 CT scanning device for providing radiation treatment planning (RTP) of an image requires
6.7.1 Positioning the patient support surface
6.7.1.1 Overview
By examining the accompanying documents to verify compliance with all positioning requirements.
6.7.1.2 Positioning the patient support in the vertical plane (tilt)
By examining the accompanying documents to verify compliance.
6.7.1.3 Positioning of the patient support in a horizontal plane
By examining the accompanying documents to verify compliance.
6.7.2 surface of the stent patients
By physical inspection to verify compliance.
6.7.3 Diagnosis bed sag (stiffness in patients with stent)
According to the following test specifications to estimate sag patient support surface on the scanning plane.
--- To the patient support surface for the beginning of the end of the gantry side, the 135kg load evenly distributed over the length of 1.9m (when insufficient
When 1.9m, the maximum length of the patient support);
--- The patient support surface of the scanner is placed on the side of the end of the scanning plane (position 1);
--- Measurement sweep plane vertical position of the patient support surface height (height 1);
--- The patient support surface of the mobile 400mm into the gantry (position 2 position = 1 400mm);
--- Measuring scanning plane in the patient support surface position vertical height (height 2);
--- The surface of the stent in the patient again gantry movement 400mm (position 3 = Position 2 400mm) and measuring the scanning plane suffering
The vertical position of the stent surface by the height (height 3);
--- The surface of the stent in the patient again gantry movement 400mm (= position 4 position 3 400mm) and measuring the scanning plane suffering
The vertical position of the stent surface by the height (height 4);
--- Calculate and record the height deviation (sag) between adjacent points.
You can scan the image above z point to measure the height of the bed of the diagnosis (for example, patient support surface to the centerline distance, etc.).
If the patient support mechanical design within the scanning time can lead to the diagnosis of sagging bed (for example, the case of hydraulic equipment), patient support
It should continue to sag in the load 1h worst position and repeat the measurement of the height of the position.
Height deviation calculation results should be recorded in a random file.
6.7.4 for patient positioning integrated positioning lights
By physical inspection to verify compliance.
Recommended use calipers to measure, but also use other more accurate methods of measurement.
6.7.5 produce the typical image scanning mode RTP
By examining the accompanying documents to verify compliance.
6.7.6 HU value conversion
By examining the accompanying documents to verify compliance.
6.7.7 geometric precision image data
6.7.7.1 Overview
By examining the accompanying documents to verify compliance.
6.7.7.2 gantry tilt
According to GB/T 19042.5-2006 The method set forth in Appendix D of conduct.
6.7.7.3 CT image angle adjustment
There will be parallel to the horizontal or vertical marks placed phantom scan area, scan and checked markers in the image point.
By measuring the reference mark with horizontal or vertical deviation to verify compliance.
Accuracy 6.7.7.4 helical scan position z
Use 0cm, 15c...
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