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WS 76-2020: (Specification for quality control and testing of medical X-ray diagnostic equipment)
Status: Valid
WS 76: Evolution and historical versions
| Std ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status |
| WS 76-2020 | English | 1849 |
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9 days [Need to translate]
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(Specification for quality control and testing of medical X-ray diagnostic equipment)
| Valid |
| WS/T 76-2017 | English | 799 |
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4 days [Need to translate]
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(Medical routine X-ray diagnostic equipment quality control testing specification)
| Obsolete |
| WS 76-2017 | English | 759 |
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4 days [Need to translate]
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Specification for testing of quality control in medical X-ray diagnostic equipment
| Obsolete |
| WS 76-2011 | English | 879 |
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4 days [Need to translate]
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Specifications for testing of image quality control in medical X-ray diagnostic equipment
| Obsolete |
| WS/T 76-1996 | English | 359 |
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3 days [Need to translate]
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General aspects for quality assurance in medical X-ray image of diagnosis
| Obsolete |
Standard similar to WS 76-2020 YY/T 0128 | YY/T 0106 | YY/T 0291 | Basic data | Standard ID | WS 76-2020 (WS76-2020) | | Description (Translated English) | (Specification for quality control and testing of medical X-ray diagnostic equipment) | | Sector / Industry | Health Industry Standard | | Classification of Chinese Standard | C43 | | Word Count Estimation | 74,734 | | Date of Issue | 2020-10-26 | | Date of Implementation | 2021-05-01 | | Older Standard (superseded by this standard) | WS 530-2017; WS 581-2017; WS 522-2017; WS 521-2017; WS 520-2017; WS 518-2017; WS 76-2017 | | Regulation (derived from) | State-health communication (2020) No. 18 | | Issuing agency(ies) | National Health Commission | WS 76-2020: (Specification for quality control and testing of medical X-ray diagnostic equipment)
---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.
Specification for testing of quality control
in medical X-ray diagnostic equipment
People's Republic of China Health Industry Standards
Replace WS 76-2017 etc.
2020-10-26 released
2021-05-01 implementation
Issued by the National Health Commission of the People's Republic of China
Table of contents
Foreword...III
1 Scope...1
2 Terms and definitions...1
3 Quality control testing requirements...5
4 General inspection items and methods of X-ray fluoroscopy equipment...8
5 Special test items and test methods for direct fluoroscopy equipment...10
6 Special test items and test methods for DSA equipment...11
7 General Items and Testing Methods for Quality Control and Testing of X-ray Photography Equipment...12
8 Special test items and test methods for screen X-ray photography equipment...15
9 Special test items and test methods for digital X-ray photography (DR) equipment...15
10 Special test items and test methods for computer X-ray photography (CR) equipment...18
11 Inspection items and methods of dental X-ray equipment...20
12 General inspection items and methods of mammography equipment...21
13 Special test items and test methods for breast screen X-ray photography equipment...25
14 Special test items and test methods for digital mammography (DR) equipment...25
15 Special test items and test methods for breast computer X-ray photography (breast CR) equipment...27
Appendix A (Normative Appendix) List of Quality Control Test Items for Medical X-ray Diagnostic Equipment...30
Appendix B (Normative Appendix) Test items and technical requirements of X-ray fluoroscopy equipment...32
Appendix C (Normative Appendix) Test items and technical requirements for X-ray photography equipment...35
Appendix D (informative appendix) Test setup conditions and technical requirements for CR systems of different manufacturers...38
Appendix E (Normative Appendix) Test Items and Technical Requirements for Dental X-ray Equipment...40
Appendix F (Normative Appendix) Inspection Items and Technical Requirements for Mammary X-ray Equipment...42
Appendix G (informative appendix) Test setup conditions and technical requirements for breast CR systems of different manufacturers...46
Appendix H (informative appendix) Calculation of average breast dose...48
Appendix I (normative appendix) X-ray equipment perspective protection area detection diagram...51
Appendix J (informative appendix) Schematic diagram of quality control inspection of dental X-ray equipment...53
Appendix K (informative appendix) Diagrams of several testing accessories and testing methods in X-ray photography...57
Appendix L (informative appendix) DSA equipment quality control test phantom example...60
Appendix M (informative appendix) Examples of several low-contrast resolution detection phantoms...61
Appendix N (informative appendix) Dental X-ray equipment quality control test phantom...62
Appendix O (informative appendix) Examples of low-contrast resolution detection phantoms for mammography equipment...63
Appendix P (informative appendix) Equipment and utensils required for quality control testing...65
References...68
Foreword
3.1～3.9, 3.10.1～3.10.8, 3.10.10～3.10.14 of this standard are mandatory clauses, and the rest are recommended clauses.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces WS 76-2017 "Specifications for Quality Control and Testing of Medical Routine X-ray Diagnostic Equipment", WS 518-2017 "Breast X
Specification for Quality Control and Inspection of Radiographic Screen Photography System, WS 520-2017 "Specification for Quality Control and Inspection of Computer X-ray Photography (CR)",
WS 521-2017 "Medical Digital X-ray Photography (DR) System Quality Control and Testing Specifications", WS 522-2017 "Digital Breast X-ray
Specification for Quality Control and Inspection of Photographic System, WS 530-2017 Specification for Quality Control and Inspection of Mammography System, and WS 581
-2017 "Specifications for Quality Control and Testing of Dental X-ray Equipment". Compared with the above standards, the main technical changes except for editorial changes are as follows.
- Modified the determination requirements for low-contrast resolution in fluoroscopy X-ray equipment (see 4.4, 7.5 of WS 76-2017);
--Added the detection of the surrounding dose equivalent rate on the detection plane of the fluoroscopy protection zone (see 4.7 and Appendix I);
--- Deleted the inspection requirements for the deviation between the irradiation field and the image receiver center in the X-ray fluoroscopy equipment (see WS 76-2017
7.8);
- Deleted the status detection requirements of the output linear items in the X-ray photography equipment (see WS 76-2017, 6.3);
-Deleted the detection requirements for the deviation of the light field and the center of the irradiation field in the X-ray photography equipment (see 6.8 of WS 76-2017);
--Modified the detection method of residual image in digital X-ray photography equipment (see 9.5, 6.6 of WS 521-2017);
--- Deleted the detection requirements of the automatic exposure control (AEC) sensitivity item in the digital X-ray photography equipment (see WS 521-2017)
6.10.1);
-Deleted the test requirements for the AEC tube voltage change consistency item in the digital X-ray photography equipment (see WS 521-2017
6.10.3);
--Delete the detection requirements for dark noise items in digital X-ray photography equipment (see 6.1 of WS 521-2017);
--Added DSA equipment quality control test items and methods (see Chapter 6);
--- Added a comparison table of test items for medical X-ray diagnostic equipment (see Table A.1);
--Modified the requirements for the maximum kerma kinetic energy rate of the air entering the body surface of the fluoroscopic examinee (see Table B.1, Table B.1 of WS 76-2017);
--In the high-dose rate mode, the requirement for the maximum value of the kerma kinetic energy rate of the air entering the body surface of the fluoroscopic examinee is added (see Table B.1);
- Increased the high contrast resolution requirements of flat panel detectors (see Table B.2);
--Modified the requirement of the air kerma kinetic energy rate in front of the maximum incident screen of the flat panel detector (see Table B.4, Table B.3 of WS 76-2017);
--Improved the half-value layer requirements for different target/filter combinations in mammography (see Table F.2);
--Added an example of the DSA equipment quality control test phantom (see Appendix L);
- Added examples of low-contrast resolution detection phantoms for mammography equipment (see Appendix O).
Drafting organizations of this standard. Institute of Radiation Protection and Nuclear Safety Medicine, Chinese Center for Disease Control and Prevention, Beijing Center for Disease Control and Prevention, Jiangxi
Jiangsu Provincial Center for Disease Control and Prevention, Institute of Radiation Medicine, Chinese Academy of Medical Sciences, Beijing Tongren Hospital Affiliated to Capital Medical University, Fujian Province
Industrial Diseases and Chemical Poisoning Prevention and Control Center, Jiangxi Institute of Occupational Disease Prevention and Control, Peking University Stomatological Hospital.
The main drafters of this standard. Xu Hui, Yue Baorong, Fan Yaohua, Wei Kedao, Lou Yun, Wang Jin, Zhang Liangan, Niu Yantao, Wei Weiqi, Chen
Yi Shui, Wang Jianchao, Huang Zhuo, Feng Zechen, Zhang Wenyi, Li Gang.
This standard replaces WS 76-2017, WS 518-2017, WS 520-2017, WS 521-2017, WS 522-2017, WS 530
-2017 and WS 581-2017.
The previous releases of WS 76-2017 are as follows.
Specification for quality control and testing of medical X-ray diagnostic equipment
1 Scope
This standard specifies the general requirements, test items, and test methods for quality control testing and protective performance testing of medical X-ray diagnostic equipment
And its technical requirements.
This standard applies to the quality control testing and protection performance testing of medical X-ray diagnostic equipment, including X-ray photography equipment [including X-ray screen
Film photography equipment, digital X-ray photography (DR) equipment, computer X-ray photography (CR) equipment], X-ray fluoroscopy equipment (including direct fluorescence
Screen fluoroscopy equipment, image intensifier fluoroscopy, flat-panel fluoroscopy equipment), dental X-ray equipment (including intraoral and extraoral machines), digital subtraction blood
DSA X-ray equipment, mammography equipment [including mammography equipment (breast screen), digital mammography equipment
Radiography (breast DR) equipment, mammography (breast CR) equipment].
Mobile X-ray equipment, portable X-ray equipment, vehicle-mounted X-ray equipment, lithotripter and medical conventional X-ray simulation positioning equipment can be used
Refer to use.
This standard does not apply to the quality control testing of X-ray computed tomography (CT) devices and cone beam CT.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Digital radiography (DR) equipment
A medical imaging device that uses digital X-ray image detector technology to achieve X-ray photography. Its image directly from the image detector
Readout is usually composed of X-ray generating device, digital X-ray imaging device and mechanical auxiliary device.
2.2
Computed radiography (CR) equipment
Reusable imaging plate is used instead of intensifying screen-film is used as the carrier to be exposed by X-ray, and the potential is obtained after exposure with laser scanning imaging plate.
Image information is collected and amplified by an optical system, and collected by a computer to obtain a digital image display of X-ray photography equipment.
2.3
Digital subtraction angiography; DSA
An angiographic imaging technique that uses computers to process digital continuous photographic image information to eliminate (subtract) bone and soft tissue images
Surgery.
2.4
Image receptor
A device used to directly convert incident X-rays into a visible image, or into a device that requires further transformation to become a visible image
Intermediate form.
Note. Image receivers such as fluorescent screens, radiographic films, imaging plates, image intensifiers or flat-panel detectors, etc.
2.5
Dental X-ray equipment
X-ray equipment dedicated to dental imaging. Among them, dental X-ray equipment with an intraoral X-ray image receiver is called an intraoral machine;
The X-ray equipment of the extraoral X-ray image receiver is called an extraoral machine.
2.6
Film spot device
In X-ray fluoroscopy, a device that takes one or more X-ray images instantaneously after selecting the site to be inspected.
2.7
Imaging plate; IP
An X-ray surface detector made of an X-ray storage luminescent material (such as fluorine barium halide).
2.8
Pre-processed image
Images that have undergone pixel defect correction, dark field correction, gain correction, and geometric distortion correction, etc. and have not yet undergone post-processing.
2.9
Detector dose indicator; DDI
It is used to reflect the specific indication of the incident dose on the image receiver during the image capture process.
2.10
Signal transfer property; STP
The difference between the average pixel value measured in the central area of the image on the incident surface of the image receiver and the kerma kinetic energy of the incident air received by the image detector
A description of the relationship.
Note. For image detectors of different manufacturers, there are different correlations between the two, such as linear, logarithmic or exponential relationships.
2.11
Focal spot to image receptor distance; SID
The distance from the effective focus center to the surface of the image receiver.
2.12
Loading factor
Various factors affecting the load of the X-ray tube.
Note. Load factors such as X-ray tube current, exposure time, cathode equivalent input power, X-ray tube voltage and ripple rate, etc.
2.13
Automatic exposure control; AEC
In the X-ray system, one or several loading factors are automatically controlled to obtain the ideal dose (dose rate) at the preselected position
Method of operation.
Note. AEC usually has various forms such as automatic dose control (ADC), automatic dose rate control (ADRC) and automatic brightness control (ABC).
2.14
Focused grid
Each plane of the absorbing strip converges into a linear grid at the specified focal point.
2.15
Focusing distance
The extended planes of the grid bars of the focusing grid converge on a line, the vertical distance between the line and the incident surface of the grid.
2.16
Radiation output
The air kerma kinetic energy produced by the X-ray useful beam current product per unit time at a given distance from the focal point, in mGy/mAs.
2.17
Specific radiation o...
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