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GBZ 138-2002 Medical X-ray Diagnosis Health Protection Monitoring Specification

Basic Information

Standard ID: GBZ 138-2002

Standard Name: Medical X-ray Diagnosis Health Protection Monitoring Specification

Chinese Name: 医用X射线诊断卫生防护监测规范

Standard category:National Standard (GB)

state:in force

Date of Release2002-04-08

Date of Implementation:2002-06-01

standard classification number

Standard ICS number:Environmental protection, health and safety >> 13.100 Occupational safety, industrial hygiene

Standard Classification Number:Medicine, Health, Labor Protection>>Health>>C57 Radiation Health Protection

associated standards

alternative situation:WS/T 190-1999

Publication information

publishing house:Legal Publishing House

ISBN:65036.139

Publication date:2004-09-12

other information

drafter:Zhang Zhixing, Zheng Junzheng

Drafting unit:Liaoning Provincial Institute of Labor Health and Occupational Disease Prevention and Control, Institute of Radiation Protection and Nuclear Safety Medicine, Chinese Center for Disease Control and Prevention

Focal point unit:Ministry of Health

Proposing unit:Ministry of Health

Publishing department:Ministry of Health of the People's Republic of China

Introduction to standards:

This standard specifies the test method for the protective performance of medical diagnostic X-ray machines (excluding C-arm X-ray machines), specifies the test requirements for the protective performance of medical diagnostic X-ray machines, and the protection monitoring requirements during the use of medical diagnostic X-ray machines. This standard applies to the production and use of medical diagnostic X-ray machines. This standard does not apply to special examinations such as interventional radiology, angiography, and X-ray CT examinations. GBZ 138-2002 Medical X-ray Diagnosis Health Protection Monitoring Specification GBZ138-2002 Standard Download Decompression Password: www.bzxz.net

Some standard content:

Ics13.100
National occupational health standard of the People's Republic of China GBZ138-2002
Specification for radiological protection monitoring in medical X-ray diagnosis2002-04-08 Issued
Ministry of Health of the People's Republic of China
2002-06-01 Implementation
1 Scope
2 Normative references
3 Terms and definitions
4 Monitoring methods for the protection performance of medical diagnostic X-ray machines 5 General requirements for medical diagnostic X-ray protection monitoring 6 Monitoring requirements for the protection performance of medical diagnostic X-ray machines 7 Protection monitoring requirements during use of medical diagnostic X-ray machines Appendix A (Normative Appendix) Schematic diagram of three-circle detection positions for leakage radiation of X-ray source components Appendix B (Normative Appendix) Schematic diagram of test points on the test plane of the protection zone for standing and supine fluoroscopy Appendix C (Normative Appendix) Detection of inherent filtration aluminum equivalent of X-ray tube components Appendix D (Normative Appendix) Schematic diagram of deviation between light field and irradiation field -
This standard is formulated in accordance with the "Law of the People's Republic of China on the Prevention and Control of Occupational Diseases". From the date of implementation of this standard, the original standard WS/T190-1999 will be invalidated at the same time.
Chapters 5, 6 and 7 of this standard are mandatory contents, and the rest are recommended contents. Based on summarizing the experience of radiation health protection supervision and monitoring of medical diagnostic X-rays in my country, this standard cites relevant international standards and national standards of my country, standardizes the detection method of the protection performance of medical diagnostic X-ray machines, and stipulates the requirements for radiation health protection monitoring of medical diagnostic X-rays. This standard is mutually complementary with the national occupational health standard GBZ130-2002 "Medical X-ray Diagnostic Health Protection Standard". Appendix A, Appendix B, Appendix C and Appendix D of this standard are normative appendices. This standard is proposed and managed by the Ministry of Health.
The drafting units of this standard: Liaoning Provincial Institute of Labor Health and Occupational Disease Prevention and Control, Institute of Radiation Protection and Nuclear Safety Medicine, Chinese Center for Disease Control and Prevention.
The main drafters of this standard: Zhang Zhixing and Zheng Junzheng. The Ministry of Health is responsible for the interpretation of this standard.
1 Scope
Health Protection for Medical X-ray Diagnosis
Monitoring Specifications
GBZ138-2002
This standard specifies the test methods for the protection performance of medical diagnostic X-ray machines (excluding C-arm X-ray machines), the test requirements for the protection performance of medical diagnostic X-ray machines, and the protection monitoring requirements for the use of medical diagnostic X-ray machines. This standard applies to the production and use of medical diagnostic X-ray machines. This standard does not apply to special examinations such as interventional radiology, angiography, and X-ray CT examinations.
Normative References
The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version shall apply to this standard.
GBZ130
Medical X-ray Diagnostic Hygiene Protection Standard
YY0062-91 Inherent Filtration of X-ray Tube Assemblies (IEC522-1976) 3 Terms and Definitions
The following terms and definitions apply to this standard. 3.1 Type inspection
Also known as routine testing, it is a comprehensive inspection of all product indicators to assess whether the product quality meets all standards and design requirements.
3.2 Factory inspection exfactory inspection The final inspection that must be carried out when the product leaves the factory to assess whether the product that has passed the type inspection meets the quality requirements confirmed by the type inspection when it leaves the factory. The factory inspection with the participation of the ordering party is also called delivery inspection. 4
Testing methods for the protective performance of medical diagnostic X-ray machines 4.1 Detection of radiation leakage from X-ray source assemblies 4.1.1 Completely seal the outlet of the X-ray source assembly (the window can be tightly sealed with a lead plate of not less than 4mm). 4.1.2 At the maximum continuous working tube current corresponding to the highest working tube voltage, use an X-ray protection monitor to scan and inspect on the spherical surface 1m away from the X-ray tube focus. If a location greater than 0.1mGy/h is found, further measurements should be taken at that location. 4.1.3 Select three circular lines on the spherical surface 1m away from the X-ray tube focus according to the schematic diagram in Appendix A, take a test point every 45°, measure the air kerma rate of the leakage radiation at 24 points, and take the average value within the 100cm area for each point. 4.1.4 For X-ray source components that can only perform photography, according to the rated capacity of the X-ray machine, the maximum total current-time product allowed per hour is loaded to measure the accumulated air kerma for 1h. 4.1.5 For X-ray machines in normal operation of the user unit, protection monitoring can be carried out. Leakage radiation detection can be carried out under the conditions of X-ray tube voltage 70kV and tube current 3mA. The evaluation standard is 0.12mGy/h. 4.2 Detection of the kerma rate of the useful beam incident on the body surface air 4.2.1 Detection of ordinary fluorescent screen X-ray machine 4.2.1.1 Place the detector in the center of the useful beam. For machines with fixed focal distance, the detector is placed on the side of the fluorescent screen 20mm away from the bed. For machines with fixed focal screen distance, the detector is placed 350mm away from the focus. For portable machines, the detector is placed at -1-
300mm away from the focus. bzxz.net
4.2.1.2 When it is confirmed that there is no additional filtering, take the tube voltage of 70kV and the tube current of 3mA for testing. 4.2.1.3 A water tank phantom is used in the test, with an outer size of 250mmx250mm×150mm, and the box wall is made of plexiglass. 4.2.2 Detection of X-ray machine with image intensifier 4.2.2.1 Place the detector in the center of the useful beam. When the X-ray tube head is under the bed, the detector is placed on the bed, and the phantom is placed 50mm above it; when the X-ray source assembly is on the bed, the detector is placed 300mm above the bed, and the phantom is placed below the detector. 4.2.2.2 For X-ray machines with automatic exposure rate control, add a 40mm aluminum attenuation layer. For machines without automatic exposure rate control, test at 70kV, 1mA.
4.3 Detection of air kerma rate on the test plane of the fluoroscopic protection area in the standing and supine positions 4.3.1 Place the water tank phantom described in 4.2.1.3 in the useful wire bundle, adjust the table-screen distance to 250mm, and adjust the irradiation field area on the fluorescent screen to 250mm×200mm.
4.3.2 Under the conditions of 70kV and 3mA, use an X-ray protection monitor to scan the test plane of the fluoroscopic protection area: if the air kerma rate of the test plane of the standing fluoroscopic protection area is greater than 5uGy·h and the air kerma rate of the test plane of the supine fluoroscopic protection area is greater than 15μGy·h, further measurements should be taken at this position. 4.3.3 According to the schematic diagrams B1 and B2 in Appendix B, measure the air kerma rate of scattered rays at 13 points in the standing position and 19 points in the supine position.
4.4 Detection of the half-value layer of the useful line beam
4.4.1 The detection of the half-value layer of the useful line beam should be carried out under narrow beam geometry conditions using a standard aluminum ladder absorber with a purity of not less than 99.9% and a thickness dimensional error of ±0.1mm. 4.4.2 Adjust the focal table distance to 100cm, set the irradiation field on the diagnostic bed to 10cm×10cm, and the line beam is perpendicular to the table surface. 4.4.3 Place aluminum absorbers of different thicknesses at 50cm above the diagnostic bed (or half the distance from the focus to the image receptor), use 80kV and appropriate mAs irradiation, measure the air kerma, and use the graphical method to obtain the half-value layer of 80kV. 4.5 Filtration detection
4.5.1 Detection of the inherent filtration aluminum equivalent of the X-ray tube assembly The detection method adopts the method specified in YY0062-91, see Appendix C. 4.5.2 Detection of the aluminum equivalent of the additional filter plate
The filter plate aluminum equivalent is detected by substitution method with the help of standard aluminum ladder absorbers. The purity of the standard aluminum ladder absorber should not be less than 99.9%, and the thickness size error is ±0.1mm. 4.6 Alignment test between the center of the irradiation field of the ordinary fluoroscopic X-ray machine and the center of the fluorescent screen 4.6.1 The fluorescent screen is placed as close to the diagnostic bed and the irradiation field is opened to the maximum. At this time, the irradiation field is smaller than the fluorescent screen. Then the fluorescent screen is pulled away. When the maximum irradiation field is equal to the size of the fluorescent screen, the table-screen distance is measured. The table-screen distance multiplied by 2 is the focal screen distance. 4.6.2 Reduce the irradiation field to 15mm×15mm and measure the distance from the center of the irradiation field to the center of the fluorescent screen. Calculate the ratio of this distance to the focal screen distance, which is the center deviation rate. 4.7 Detection of focal skin distance
4.7.1. The focal skin distance (focal table distance for a diagnostic bed) is tested by using two circles made of fine metal wires, with the diameter of the larger circle being twice that of the smaller circle.
4.7.2 Stick the smaller circle in the middle of the diagnostic bed and the larger circle in the center of the incident surface of the fluorescent screen. Perform perspective under low conditions and pull the fluorescent screen away until the two circles of images overlap. 4.7.3 Measure the focal table distance, which is the focal skin distance. 4.8. Testing of the sensitivity of the perspective fluorescent screen
4.8.1 When the table screen distance is the smallest, the irradiation field is opened to the maximum, and the detector is placed on the incident surface of the fluorescent screen, irradiate with 60kV and 3mA, and measure the kerma rate.
4.8.2 Under the same conditions, measure the brightness of the fluorescent screen with a screen brightness meter. The ratio of the brightness of the fluorescent screen to the kerma rate is the sensitivity of the fluorescent screen.
—2—
4.9 Detection of deviation between light field and irradiation field
4.9.1 Place a film of sufficient size on the cassette holder of the horizontal diagnostic bed, and place the collimation test plate on the bed at the corresponding cassette position. 4.9.2 Adjust the focal length to 100cm, so that the boundary of the light field coincides with the rectangular frame of the detection plate, and irradiate with 60kV, 5mAs. 4.9.3 When the light field is enlarged to coincide with the outer edge of the detection plate, irradiate with 60kV, 1mAs. 4.9.4 Measure the distance between the edges of the two images on the film. The ratio of the sum of the absolute values ​​of the corresponding edge distances to the vertical distance from the focus of the X-ray tube to the film is the corresponding deviation rate, see the schematic diagram in Appendix D. 5 General requirements for medical diagnostic X-ray protection monitoring 5.1 The protection monitoring of medical X-ray diagnosis should include the protection performance test of the X-ray machine, the inspection and testing of the protection facilities of the X-ray machine room, the inspection and testing of the radiation safety around the X-ray machine room, and the protection evaluation of the working conditions of the staff, the protection of the examinees, and the radiation safety around the machine room in accordance with the relevant national standards. 5.2 Before the protection performance test of the medical diagnostic X-ray machine, the X-ray machine files should be checked, including the X-ray machine product manual, maintenance records, X-ray machine acceptance test records, and quality control test results, and the electrical performance of the X-ray machine should be adjusted to normal before the protection performance test is carried out. 5.3 The instruments used for protection performance testing should have a statutory metrological verification certificate. 5.4 The instrument used for monitoring stray radiation protection should have the following main performances: a) Minimum range: 0~10μGyh;
b) Energy response: 10~60keV±40%
c) Reading response time: less than 15s;
d) There should be a cumulative dose measurement range.
6 Testing requirements for the protection performance of medical diagnostic X-ray machine products 6.1 The protection performance of X-ray machine products should comply with GBZ130 and can only be shipped after meeting the factory inspection requirements. The provincial radiation health protection department where the manufacturer is located can conduct random inspections on the protection performance of the factory's X-ray machine products. 6.2 The factory inspection of X-ray machine products should at least include the leakage radiation of the X-ray source components specified in GBZ130, the air kerma rate of the useful beam incident on the body surface, and the air kerma rate on the test plane of the standing and supine fluoroscopic protection area, etc., and the inspection should be carried out according to the method proposed in this standard. 6.3 Type inspection shall be conducted in any of the following situations: a) before new products are put into production; b) for products in continuous production, at least once every two years; c) when the equipment is put into production again after an interval of more than one year; d) when there are major changes in design, process or materials. Type inspection shall be conducted in accordance with the technical requirements for protection performance specified in GBZ130 and the methods proposed in this standard. The results of type inspection shall be submitted to the provincial radiation health protection department where the manufacturer is located for record. 7 Requirements for protection monitoring during use of medical diagnostic X-ray machines 7.1 After a new medical diagnostic X-ray machine is installed, the protection performance of the X-ray machine shall be fully inspected, and the protection facilities of the X-ray machine room and the radiation safety of the surrounding environment of the room shall be inspected and tested. It can only be put into use after passing the inspection. 7.2 When a medical diagnostic X-ray machine has undergone a major overhaul, its protection performance shall also be fully inspected 7.3 For medical diagnostic X-ray machines in normal use, the main protection performance of the X-ray machine and the inspection and testing of the protection facilities of the room shall generally be conducted once a year.
7.4 For X-ray machines in use, the radiation leakage detection of the X-ray source components shall be carried out in accordance with the requirements of 4.1.5 without using the rated capacity working conditions.
7.5 The radiation protection level detection of various operating positions for medical X-ray diagnosis (including the air release rate on the test plane of the perspective protection area, the radiation level detection of the photography operation area, etc.) can provide a partial basis for evaluating the occupational exposure of the staff, but the specific evaluation should be carried out in combination with the actual workload of each staff member. 5 During the inspection and testing of the protective facilities in the X-ray machine room, attention should be paid to the inspection of the ionizing radiation signs and working indicator lights in the room, the safety of the waiting position for the examinee, and various auxiliary protective supplies for the staff and the examinee. Appendix A
(Normative appendix)
Schematic diagram of three-circle detection positions for leakage radiation of X-ray source componentsA1The schematic diagram of three-circle detection positions for leakage radiation of X-ray source components is shown in Figure A1.4
Figure A1Schematic diagram of three-circle detection positions for leakage radiation of X-ray source componentsAppendix B
(Normative appendix)
Schematic diagram of test points on the test plane of the fluoroscopic protection area in standing and supine positionsThe schematic diagram of test points on the test plane of the fluoroscopic protection area in standing and supine positions is shown in Figures B1 and B2. B1
Unit: mm
Test plane one
Fluorescent screen
Irradiation field
Test plane one
Standing perspective protection area test plane
Test point diagram
Unit: mm
Test plane on bed
Test plane on bed
Test point diagram of test plane on supine perspective protection area Appendix C
(Normative Appendix)
Detection of inherent filtration aluminum equivalent of X-ray tube assembly 5
The detection method is the same as the method specified in YY0062-91. C1
Expression method
Value and reference material
C1.1 The inherent filtration value of the X-ray tube assembly working under specified conditions is expressed as the thickness of a reference material. C1.2 Intrinsic filtration must be expressed as follows. C1.2.1 When the X-ray tube window and the X-ray tube jacket window are essentially composed of beryllium or other weak filtering materials, it shall be expressed as the thickness of the beryllium or other material.
C1.2.2 When the X-ray tube assembly is operated at a tube voltage below 200 kV, it shall be expressed as the thickness of aluminum. C1.2.3 When the X-ray tube assembly is operated at a tube voltage of 150 to 400 kV, it shall be expressed as the thickness of copper. C1.2.4 The stated value of inherent filtration must be less than or equal to the measured value and should be within 85% to 100% of the measured value. C1.2.5 The thickness of the reference material must be expressed in millimeters, the reference material in chemical symbols, and the tube voltage in kilovolts. C2 Measurements
C2.1 The determination of inherent filtration must be made on the central axis of the bundle by measuring the initial half-value layer and an X-ray tube with a beryllium window (other material windows with negligible filtering) of the same target material and target angle. The half-value layers of the radiation emitted when working under the same tube voltage value and waveform and the same tube current conditions are compared. C2.2 Unless otherwise specified, the measurement must be made at half the maximum tube voltage. C2.3 If there is no X-ray tube with the same target angle, the X-ray tube can be tilted and adjusted to the same target angle to emit the radiation beam. Appendix D
(Normative Appendix)
Schematic diagram of the deviation between the light field and the irradiation field
D1 Schematic diagram of the deviation between the light field and the irradiation field is shown in Figure D1. Light field
X-ray irradiation field
Figure D1 Schematic diagram of the deviation between the light field and the irradiation field 64 Measure the distance between the edges of the two images on the film. The ratio of the sum of the absolute values ​​of the corresponding edge distances to the vertical distance from the focus of the X-ray tube to the film is the corresponding deviation rate, see the schematic diagram in Appendix D. 5 General requirements for medical diagnostic X-ray protection monitoring 5.1 Protection monitoring for medical X-ray diagnosis should include X-ray machine protection performance testing, inspection and testing of X-ray machine room protection facilities, inspection and testing of radiation safety around the X-ray machine room, and protection evaluation of staff working conditions, subject protection, and radiation safety around the machine room in accordance with relevant national standards. 5.2 Before testing the protection performance of medical diagnostic X-ray machines, the X-ray machine files should be checked, including the X-ray machine product manual, maintenance records, X-ray machine acceptance inspection records, and quality control inspection conditions, and the electrical performance of the X-ray machine should be adjusted to normal before the protection performance test is carried out. 5.3 Instruments used for protection performance testing should have a statutory metrological verification certificate. 5.4 The instrument used for monitoring stray radiation protection should have the following main performances: a) Minimum range: 0~10μGyh;
b) Energy response: 10~60keV±40%
c) Reading response time: less than 15s;
d) There should be a cumulative dose measurement range.
6 Testing requirements for the protection performance of medical diagnostic X-ray machine products 6.1 The protection performance of X-ray machine products should comply with GBZ130 and can only be shipped after meeting the factory inspection requirements. The provincial radiation health protection department where the manufacturer is located can conduct random inspections on the protection performance of the factory's X-ray machine products. 6.2 The factory inspection of X-ray machine products should at least include the leakage radiation of the X-ray source components specified in GBZ130, the air kerma rate of the useful beam incident on the body surface, and the air kerma rate on the test plane of the standing and supine fluoroscopic protection area, etc., and the inspection should be carried out according to the method proposed in this standard. 6.3 Type inspection shall be conducted in any of the following situations: a) before new products are put into production; b) for products in continuous production, at least once every two years; c) when the equipment is put into production again after an interval of more than one year; d) when there are major changes in design, process or materials. Type inspection shall be conducted in accordance with the technical requirements for protection performance specified in GBZ130 and the methods proposed in this standard. The results of type inspection shall be submitted to the provincial radiation health protection department where the manufacturer is located for record. 7 Requirements for protection monitoring during use of medical diagnostic X-ray machines 7.1 After a new medical diagnostic X-ray machine is installed, the protection performance of the X-ray machine shall be fully inspected, and the protection facilities of the X-ray machine room and the radiation safety of the surrounding environment of the room shall be inspected and tested. It can only be put into use after passing the inspection. 7.2 When a medical diagnostic X-ray machine has undergone a major overhaul, its protection performance shall also be fully inspected 7.3 For medical diagnostic X-ray machines in normal use, the main protection performance of the X-ray machine and the inspection and testing of the protection facilities of the room shall generally be conducted once a year.
7.4 For X-ray machines in use, the radiation leakage detection of the X-ray source components shall be carried out in accordance with the requirements of 4.1.5 without using the rated capacity working conditions.
7.5 The radiation protection level detection of various operating positions for medical X-ray diagnosis (including the air release rate on the test plane of the perspective protection area, the radiation level detection of the photography operation area, etc.) can provide a partial basis for evaluating the occupational exposure of the staff, but the specific evaluation should be carried out in combination with the actual workload of each staff member. 5 During the inspection and testing of the protective facilities in the X-ray machine room, attention should be paid to the inspection of the ionizing radiation signs and working indicator lights in the room, the safety of the waiting position for the examinee, and various auxiliary protective supplies for the staff and the examinee. Appendix A
(Normative appendix)
Schematic diagram of three-circle detection positions for leakage radiation of X-ray source componentsA1The schematic diagram of three-circle detection positions for leakage radiation of X-ray source components is shown in Figure A1.4
Figure A1Schematic diagram of three-circle detection positions for leakage radiation of X-ray source componentsAppendix B
(Normative appendix)
Schematic diagram of test points on the test plane of the fluoroscopic protection area in standing and supine positionsThe schematic diagram of test points on the test plane of the fluoroscopic protection area in standing and supine positions is shown in Figures B1 and B2. B1
Unit: mm
Test plane one
Fluorescent screen
Irradiation field
Test plane one
Standing perspective protection area test plane
Test point diagram
Unit: mm
Test plane on bed
Test plane on bed
Test point diagram of test plane on supine perspective protection area Appendix C
(Normative Appendix)
Detection of inherent filtration aluminum equivalent of X-ray tube assembly 5
The detection method is the same as the method specified in YY0062-91. C1
Expression method
Value and reference material
C1.1 The inherent filtration value of the X-ray tube assembly working under specified conditions is expressed as the thickness of a reference material. C1.2 Intrinsic filtration must be expressed as follows. C1.2.1 When the X-ray tube window and the X-ray tube jacket window are essentially composed of beryllium or other weak filtering materials, it shall be expressed as the thickness of the beryllium or other material.
C1.2.2 When the X-ray tube assembly is operated at a tube voltage below 200 kV, it shall be expressed as the thickness of aluminum. C1.2.3 When the X-ray tube assembly is operated at a tube voltage of 150 to 400 kV, it shall be expressed as the thickness of copper. C1.2.4 The stated value of inherent filtration must be less than or equal to the measured value and should be within 85% to 100% of the measured value. C1.2.5 The thickness of the reference material must be expressed in millimeters, the reference material in chemical symbols, and the tube voltage in kilovolts. C2 Measurements
C2.1 The determination of inherent filtration must be made on the central axis of the bundle by measuring the initial half-value layer and an X-ray tube with a beryllium window (other material windows with negligible filtering) of the same target material and target angle. The half-value layers of the radiation emitted when working under the same tube voltage value and waveform and the same tube current conditions are compared. C2.2 Unless otherwise specified, the measurement must be made at half the maximum tube voltage. C2.3 If there is no X-ray tube with the same target angle, the X-ray tube can be tilted and adjusted to the same target angle to emit the radiation beam. Appendix D
(Normative Appendix)
Schematic diagram of the deviation between the light field and the irradiation field
D1 Schematic diagram of the deviation between the light field and the irradiation field is shown in Figure D1. Light field
X-ray irradiation field
Figure D1 Schematic diagram of the deviation between the light field and the irradiation field 64 Measure the distance between the edges of the two images on the film. The ratio of the sum of the absolute values ​​of the corresponding edge distances to the vertical distance from the focus of the X-ray tube to the film is the corresponding deviation rate, see the schematic diagram in Appendix D. 5 General requirements for medical diagnostic X-ray protection monitoring 5.1 Protection monitoring for medical X-ray diagnosis should include X-ray machine protection performance testing, inspection and testing of X-ray machine room protection facilities, inspection and testing of radiation safety around the X-ray machine room, and protection evaluation of staff working conditions, subject protection, and radiation safety around the machine room in accordance with relevant national standards. 5.2 Before testing the protection performance of medical diagnostic X-ray machines, the X-ray machine files should be checked, including the X-ray machine product manual, maintenance records, X-ray machine acceptance inspection records, and quality control inspection conditions, and the electrical performance of the X-ray machine should be adjusted to normal before the protection performance test is carried out. 5.3 Instruments used for protection performance testing should have a statutory metrological verification certificate. 5.4 The instrument used for monitoring stray radiation protection should have the following main performances: a) Minimum range: 0~10μGyh;
b) Energy response: 10~60keV±40%
c) Reading response time: less than 15s;
d) There should be a cumulative dose measurement range.
6 Testing requirements for the protection performance of medical diagnostic X-ray machine products 6.1 The protection performance of X-ray machine products should comply with GBZ130 and can only be shipped after meeting the factory inspection requirements. The provincial radiation health protection department where the manufacturer is located can conduct random inspections on the protection performance of the factory's X-ray machine products. 6.2 The factory inspection of X-ray machine products should at least include the leakage radiation of the X-ray source components specified in GBZ130, the air kerma rate of the useful beam incident on the body surface, and the air kerma rate on the test plane of the standing and supine fluoroscopic protection area, etc., and the inspection should be carried out according to the method proposed in this standard. 6.3 Type inspection shall be conducted in any of the following situations: a) before new products are put into production; b) for products in continuous production, at least once every two years; c) when the equipment is put into production again after an interval of more than one year; d) when there are major changes in design, process or materials. Type inspection shall be conducted in accordance with the technical requirements for protection performance specified in GBZ130 and the methods proposed in this standard. The results of type inspection shall be submitted to the provincial radiation health protection department where the manufacturer is located for record. 7 Requirements for protection monitoring during use of medical diagnostic X-ray machines 7.1 After a new medical diagnostic X-ray machine is installed, the protection performance of the X-ray machine shall be fully inspected, and the protection facilities of the X-ray machine room and the radiation safety of the surrounding environment of the room shall be inspected and tested. It can only be put into use after passing the inspection. 7.2 When a medical diagnostic X-ray machine has undergone a major overhaul, its protection performance shall also be fully inspected 7.3 For medical diagnostic X-ray machines in normal use, the main protection performance of the X-ray machine and the inspection and testing of the protection facilities of the room shall generally be conducted once a year.
7.4 For X-ray machines in use, the radiation leakage detection of the X-ray source components shall be carried out in accordance with the requirements of 4.1.5 without using the rated capacity working conditions.
7.5 The radiation protection level detection of various operating positions for medical X-ray diagnosis (including the air release rate on the test plane of the perspective protection area, the radiation level detection of the photography operation area, etc.) can provide a partial basis for evaluating the occupational exposure of the staff, but the specific evaluation should be carried out in combination with the actual workload of each staff member. 5 During the inspection and testing of the protective facilities in the X-ray machine room, attention should be paid to the inspection of the ionizing radiation signs and working indicator lights in the room, the safety of the waiting position for the examinee, and various auxiliary protective supplies for the staff and the examinee. Appendix A
(Normative appendix)
Schematic diagram of three-circle detection positions for leakage radiation of X-ray source componentsA1The schematic diagram of three-circle detection positions for leakage radiation of X-ray source components is shown in Figure A1.4
Figure A1Schematic diagram of three-circle detection positions for leakage radiation of X-ray source componentsAppendix B
(Normative appendix)
Schematic diagram of test points on the test plane of the fluoroscopic protection area in standing and supine positionsThe schematic diagram of test points on the test plane of the fluoroscopic protection area in standing and supine positions is shown in Figures B1 and B2. B1
Unit: mm
Test plane one
Fluorescent screen
Irradiation field
Test plane one
Standing perspective protection area test plane
Test point diagram
Unit: mm
Test plane on bed
Test plane on bed
Test point diagram of test plane on supine perspective protection area Appendix C
(Normative Appendix)
Detection of inherent filtration aluminum equivalent of X-ray tube assembly 5
The detection method is the same as the method specified in YY0062-91. C1
Expression method
Value and reference material
C1.1 The inherent filtration value of the X-ray tube assembly working under specified conditions is expressed as the thickness of a reference material. C1.2 Intrinsic filtration must be expressed as follows. C1.2.1 When the X-ray tube window and the X-ray tube jacket window are essentially composed of beryllium or other weak filtering materials, it shall be expressed as the thickness of the beryllium or other material.
C1.2.2 When the X-ray tube assembly is operated at a tube voltage below 200 kV, it shall be expressed as the thickness of aluminum. C1.2.3 When the X-ray tube assembly is operated at a tube voltage of 150 to 400 kV, it shall be expressed as the thickness of copper. C1.2.4 The stated value of inherent filtration must be less than or equal to the measured value and should be within 85% to 100% of the measured value. C1.2.5 The thickness of the reference material must be expressed in millimeters, the reference material in chemical symbols, and the tube voltage in kilovolts. C2 Measurements
C2.1 The determination of inherent filtration must be made on the central axis of the bundle by measuring the initial half-value layer and an X-ray tube with a beryllium window (other material windows with negligible filtering) of the same target material and target angle. The half-value layers of the radiation emitted when working under the same tube voltage value and waveform and the same tube current conditions are compared. C2.2 Unless otherwise specified, the measurement must be made at half the maximum tube voltage. C2.3 If there is no X-ray tube with the same target angle, the X-ray tube can be tilted and adjusted to the same target angle to emit the radiation beam. Appendix D
(Normative Appendix)
Schematic diagram of the deviation between the light field and the irradiation field
D1 Schematic diagram of the deviation between the light field and the irradiation field is shown in Figure D1. Light field
X-ray irradiation field
Figure D1 Schematic diagram of the deviation between the light field and the irradiation field 61 After the medical diagnostic X-ray machine is newly installed, the protective performance of the X-ray machine should be fully tested, and the protective facilities of the X-ray machine room and the radiation safety of the surrounding environment of the room should be inspected and tested. It can only be put into use after passing the inspection. 7.2 When the medical diagnostic X-ray machine has undergone a major overhaul, its protective performance should also be fully tested. 7.3 For medical diagnostic X-ray machines in normal use, the main protective performance of the X-ray machine and the inspection and test of the protective facilities of the machine room are generally carried out once a year.
7.4 For X-ray machines in use, the radiation leakage detection of the X-ray source components shall be carried out according to the requirements of Article 4.1.5 without the rated capacity working conditions.
7.5 The radiation protection level detection of various operating positions of medical X-ray diagnosis (including the air release rate on the test plane of the perspective protection area, the radiation level detection of the photography operation area, etc.) can provide a part of the basis for evaluating the occupational exposure of the staff, but the specific evaluation should be carried out in combination with the actual workload of each staff member. 5During the inspection and testing of the protective facilities in the X-ray machine room, attention should be paid to the inspection of the ionizing radiation signs and working indicator lights in the room, the safety of the waiting position for the examinee7.6
, and various auxiliary protective equipment for the staff and the examinee. Appendix A
(Normative Appendix)
Schematic diagram of the three-circle detection position of the X-ray source component leakage radiationA1Schematic diagram of the three-circle detection position of the X-ray source component leakage radiationSee Figure A1.4
Figure A1Schematic diagram of the three-circle detection position of the X-ray source component leakage radiationAppendix B
(Normative Appendix)
Schematic diagram of the test plane test points of the standing and supine fluoroscopic protection areaSee Figures B1 and B2 for the schematic diagram of the test plane test points of the standing and supine fluoroscopic protection area. B1
Unit: mm
Test plane one
Fluorescent screen
Irradiation field
Test plane one
Standing perspective protection area test plane
Test point diagram
Unit: mm
Test plane on bed
Test plane on bed
Test point diagram of test plane on supine perspective protection area Appendix C
(Normative Appendix)
Detection of inherent filtration aluminum equivalent of X-ray tube assembly 5
The detection method is the same as the method specified in YY0062-91. C1
Expression method
Value and reference material
C1.1 The inherent filtration value of the X-ray tube assembly working under specified conditions is expressed as the thickness of a reference material. C1.2 Intrinsic filtration must be expressed as follows. C1.2.1 When the X-ray tube window and the X-ray tube jacket window are essentially composed of beryllium or other weak filtering materials, it shall be expressed as the thickness of the beryllium or other material.
C1.2.2 When the X-ray tube assembly is operated at a tube voltage below 200 kV, it shall be expressed as the thickness of aluminum. C1.2.3 When the X-ray tube assembly is operated at a tube voltage of 150 to 400 kV, it shall be expressed as the thickness of copper. C1.2.4 The stated value of inherent filtration must be less than or equal to the measured value and should be within 85% to 100% of the measured value. C1.2.5 The thickness of the reference material must be expressed in millimeters, the reference material in chemical symbols, and the tube voltage in kilovolts. C2 Measurements
C2.1 The determination of inherent filtration must be made on the central axis of the bundle by measuring the initial half-value layer and an X-ray tube with a beryllium window (other material windows with negligible filtering) of the same target material and target angle. The half-value layers of the radiation emitted when working under the same tube voltage value and waveform and the same tube current conditions are compared. C2.2 Unless otherwise specified, the measurement must be made at half the maximum tube voltage. C2.3 If there is no X-ray tube with the same target angle, the X-ray tube can be tilted and adjusted to the same target angle to emit the radiation beam. Appendix D
(Normative Appendix)
Schematic diagram of the deviation between the light field and the irradiation field
D1 Schematic diagram of the deviation between the light field and the irradiation field is shown in Figure D1. Light field
X-ray irradiation field
Figure D1 Schematic diagram of the deviation between the light field and the irradiation field 61 After the medical diagnostic X-ray machine is newly installed, the protective performance of the X-ray machine should be fully tested, and the protective facilities of the X-ray machine room and the radiation safety of the surrounding environment of the room should be inspected and tested. It can only be put into use after passing the inspection. 7.2 When the medical diagnostic X-ray machine has undergone a major overhaul, its protective performance should also be fully tested. 7.3 For medical diagnostic X-ray machines in normal use, the main protective performance of the X-ray machine and the inspection and test of the protective facilities of the machine room are generally carried out once a year.
7.4 For X-ray machines in use, the radiation leakage detection of the X-ray source components shall be carried out according to the requirements of Article 4.1.5 without the rated capacity working conditions.
7.5 The radiation protection level detection of various operating positions of medical X-ray diagnosis (including the air release rate on the test plane of the perspective protection area, the radiation level detection of the photography operation area, etc.) can provide a part of the basis for evaluating the occupational exposure of the staff, but the specific evaluation should be carried out in combination with the actual workload of each staff member. 5During the inspection and testing of the protective facilities in the X-ray machine room, attention should be paid to the inspection of the ionizing radiation signs and working indicator lights in the room, the safety of the waiting position for the examinee7.6
, and various auxiliary protective equipment for the staff and the examinee. Appendix A
(Normative Appendix)
Schematic diagram of the three-circle detection position of the X-ray source component leakage radiationA1Schematic diagram of the three-circle detection position of the X-ray source component leakage radiationSee Figure A1.4
Figure A1Schematic diagram of the three-circle detection position of the X-ray source component leakage radiationAppendix B
(Normative Appendix)
Schematic diagram of the test plane test points of the standing and supine fluoroscopic protection areaSee Figures B1 and B2 for the schematic diagram of the test plane test points of the standing and supine fluoroscopic protection area. B1
Unit: mm
Test plane one
Fluorescent screen
Irradiation field
Test plane one
Standing perspective protection area test plane
Test point diagram
Unit: mm
Test plane on bed
Test plane on bed
Test point diagram of test plane on supine perspective protection area Appendix C
(Normative Appendix)
Detection of inherent filtration aluminum equivalent of X-ray tube assembly 5
The detection method is the same as the method specified in YY0062-91. C1
Expression method
Value and reference material
C1.1 The inherent filtration value of the X-ray tube assembly working under specified conditions is expressed as the thickness of a reference material. C1.2 Intrinsic filtration must be expressed as follows. C1.2.1 When the X-ray tube window and the X-ray tube jacket window are essentially composed of beryllium or other weak filtering materials, it shall be expressed as the thickness of the beryllium or other material.
C1.2.2 When the X-ray tube assembly is operated at a tube voltage below 200 kV, it shall be expressed as the thickness of aluminum. C1.2.3 When the X-ray tube assembly is operated at a tube voltage of 150 to 400 kV, it shall be expressed as the thickness of copper. C1.2.4 The stated value of inherent filtration must be less than or equal to the measured value and should be within 85% to 100% of the measured value. C1.2.5 The thickness of the reference material must be expressed in millimeters, the reference material in chemical symbols, and the tube voltage in kilovolts. C2 Measurements
C2.1 The determination of inherent filtration must be made on the central axis of the bundle by measuring the initial half-value layer and an X-ray tube with a beryllium window (other material windows with negligible filtering) of the same target material and target angle. The half-value layers of the radiation emitted when working under the same tube voltage value and waveform and the same tube current conditions are compared. C2.2 Unless otherwise specified, the measurement must be made at half the maximum tube voltage. C2.3 If there is no X-ray tube with the same target angle, the X-ray tube can be tilted and adjusted to the same target angle to emit the radiation beam. Appendix D
(Normative Appendix)
Schematic diagram of the deviation between the light field and the irradiation field
D1 Schematic diagram of the deviation between the light field and the irradiation field is shown in Figure D1. Light field
X-ray irradiation field
Figure D1 Schematic diagram of the deviation between the light field and the irradiation field 6
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