WS 581-2017 yá kē Xshè xiàn shè bè i zhì liàng kòng zhì jiǎn cè guī fàn
2 English ReferenceSpecification for testing of quality control in dental Xray equipment
3 Basic InformationICS 13.280 C 57
The People's Republic of China*** and the State Health Industry Standard WS 581-2017 Specification for testing of quality control in dental X-ray equipment was published by the People's Republic of China*** and the National Health and Family Planning Commission on October 27, 2017, and implemented from May 01, 2018 onwards.
4 PrefaceThis standard 4.1 to 4.7 is mandatory, and the rest is recommended.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was drafted by: China Center for Disease Control and Prevention, Institute of Radiation Protection and Nuclear Safety Medicine, Beijing Municipal Center for Disease Control and Prevention, Peking University Stomatological Hospital, Fujian Provincial Center for the Prevention and Control of Occupational Diseases and Chemical Poisoning, and Beijing Chaoyang District Center for Disease Control and Prevention.
The main drafters of this standard: Xu Hui, Yue Baorong, Fan Yaohua, Yu Kedao, Wang Jianchao, Huang Zhuo, Lou Yun, Feng Zechen, Wang Xiaoyan, Wei Weiqi, Zhao Hongfeng, Li Gang.
5 Standard TextDental X-ray equipment quality control inspection specifications
5.1 1 ScopeThis standard specifies the requirements and methods for dental X-ray equipment quality control inspection.
This standard applies to the quality control testing of dental X-ray equipment with intraoral X-ray image receivers and dental X-ray equipment with extraoral X-ray image receivers.
This standard does not apply to quality control testing of dental CT.
5.2 2 Normative referencesThe following documents are essential to the application of this document. Where a document is dated, only the dated version applies to this document. Where a referenced document is not dated, the latest version (including all change orders) applies to this document.
GB 9706.12? Medical electrical equipment Part I: General requirements for safety III. Concurrent standards General requirements for radiation protection of diagnostic X-ray equipment
5.3 3 Terminology and definitionsThe following terminology and definitions apply to this document.
3.1
Dental X-ray equipment dental Xray equipment
X-ray equipment dedicated to dental imaging.
3.2
dental intraoral X-ray equipment dental intraoral Xray equipment
Intraoral machine
An X-ray machine with an intraoral X-ray image receiver for taking dental X-ray images.
3.3
dental extraoral X-ray equipment dental extraoral Xray equipment
Extraoral machine
An X-ray machine with an extraoral X-ray image receiver for taking X-ray images of teeth and jaws.
Note: Extraoral machines typically include panoramic radiographic capability and cephalometric capability.
5.4 4 General requirements for quality control testing4.1 Dental X-ray equipment after installation and overhaul, should be in accordance with this standard, or in accordance with the technical requirements agreed in the purchase contract for acceptance testing; in the normal use of dental X-ray equipment, should be required to carry out condition testing, condition testing should be carried out once a year. Dental X-ray equipment in use, should be carried out periodically for stability testing, stability testing of the cycle see Table A.1 in Appendix A. Stability test results and the baseline value of the deviation is greater than the control standard, and can not determine the cause should be carried out when the state of the test.
4.2 Acceptance testing should be entrusted to qualified testing organizations. Legal entities, manufacturers and testing organizations *** with the cooperation to complete. Status testing should be entrusted to qualified testing organizations. Stability testing should be implemented by the medical unit itself or entrusted to a competent organization to carry out testing.
4.3 Acceptance test results of the newly installed dental X-ray equipment should be in line with the product performance indicators listed in the randomized documents, the two sides of the contract or agreement in the technical terms, but shall not be less than the requirements of this standard. Items not specified by the supplier shall meet the requirements of this standard.
4.4 Dental X-ray equipment quality control test items should cover the items specified in this standard, the function does not have or can not meet the test conditions of the equipment inspected by the corresponding test items should be described in the test report.
4.5 Dental X-ray equipment quality control test items and testing methods are described in Chapter 5, the evaluation should be consistent with the requirements of Appendix A, Table A.1. Test results equal to or better than the index values specified in this standard is qualified.
4.6 Quality control testing should be testing records, acceptance testing and condition testing should also issue a test report. The basic content of the test report should include: the basic information of the unit being inspected and equipment information, testing items and testing methods, the necessary testing conditions, test results and their corresponding standard requirements.
4.7 Dental X-ray equipment quality control testing test schematic diagram in Appendix B.
4.8 Dental X-ray equipment quality control test mold examples see Appendix C.
4.9 Dental X-ray equipment quality control testing equipment and appliances required to see Appendix D, Table D.1.
5.5 5 quality control testing methods 5.5.1 5.1 Requirements for testing instruments and molds5.1.1 Testing instruments should be tested or calibrated in accordance with relevant regulations, and the results should be traceable.
5.1.2 When detecting the tube voltage, adopt digital high-voltage measuring instrument and use non-invasive methods for detection.
5.1.3 Detection of half-value layer used in the standard aluminum absorption sheet, aluminum purity should not be less than 99.5%, thickness size error should be within ± 0.1mm. Aluminum size should be at least fully covered by the dosimeter detector sensitive area.
5.1.4 High-contrast resolution test module in the line to meet the range of at least: digital imaging dental X-ray equipment 1.6 lp/mm ~ 3.0 lp/mm.
5.1.5 Low-contrast resolution test module should include at least 0.5 mm thick aluminum plate above the diameter of 1.0 mm, 1.5 mm, 2.0 mm and 2.5 mm. round holes.
5.5.2 5.2 Deviation of tube voltage indication5.2.1 The digital HV meter should be set according to the type of HV generator, test parameters, etc. of the equipment being tested.
5.2.2 For intraoral machines, place the kV detector close to the exit of the beam-limiting cylinder, with the effective measurement point at the center axis of the main beam and the detector surface perpendicular to the center axis of the main beam, to ensure that the detector is completely covered by the X-ray beam. The test schematic is shown in Fig. B.1.
5.2.3 For the panoramic photography function of the outboard camera, use the non-developmental film to find out the position of the shot field on the image receiver, place the kV detector on the surface of the image receiver housing, with the effective measuring point located at the center axis of the main beam and make the detector surface perpendicular to the center axis of the main beam. The test schematic is shown in Figure B.2.
5.2.4 For the cephalometric function of the extra-oral machine, use the non-developmental film to find the position of the field of fire on the outer side of the secondary diaphragm, and then place the kV detector on the outer side of the secondary diaphragm, with the effective measuring point located on the center axis of the main beam and the detector surface perpendicular to the center axis of the main beam. The test schematic is shown in Fig. B.3.
5.2.5 During the acceptance test, the lowest, middle and highest three tube voltages of the adjustable tube voltage equipment are set; during the status test, the commonly used gears of the equipment can be used for the test. Repeat the exposure at least 3 times, record the measured value of each tube voltage, and calculate its average value. - average value of tube voltage measurement in kilovolts (kV);
V0 - preset value of tube voltage in kilovolts (kV).
5.5.3 5.3 Output Repeatability5.3.1 For intraoral machines, place the dose detector close to the exit of the beam-limiting cylinder, with its effective measurement point at the center axis of the main beam and with the surface of the detector perpendicular to the center axis of the main beam to ensure that the X-ray beam completely covers the detector. A schematic diagram of the test is shown in Figure B.1.
5.3.2 Exposure under the usual adult exposure conditions of the equipment, 5 consecutive exposures, recording the dose value for each exposure and calculating the repeatability of the radiation output using equation (2):
Where:
CV - coefficient of variation, %;
p> Ki - the value of each radiation output measurement in milligray per milliampere second (mGy/mAs);
- the average of n radiation output measurements in milligray per milliampere second (mGy/mAs);
n - the total number of measurements of radiation output.
5.5.4 5.4 Loading time deviation5.4.1 Test geometric conditions are the same as 5.2.1 to 5.2.4.
5.4.2 With the equipment commonly used for adult exposure conditions, three consecutive exposures, record the measurement time displayed by the dosimeter after each exposure, and calculate the average value.
5.4.3 Compare the loading time test average with the device display.
5.4.4 Calculate the deviation of loading time according to equation (3):
Where:
ET - deviation of loading time;
Ti - average value of loading time measurement in milliseconds (ms);
T0 - loading time preset value in milliseconds (ms).
5.5.5 5.5 Useful harness half-value layer 5.5.5.1 5.5.1 Method 1: Aluminum sheet method5.5.1.1 Test geometric conditions are the same as those of 5.2.1 to 5.2.4.
5.5.1.2 Setting the common tube voltage of the equipment from 1 to 3 steps and exposure, and record the value of the air-specific release of kinetic energy rate.
5.5.1.3 Place the aluminum sheet in the position of the X-ray outlet of the dome tube, keep the exposure conditions unchanged, and measure the air specific kinetic energy rate value after different thicknesses of the aluminum sheet.
5.5.1.4 Gradually increase the thickness of the aluminum sheet until the measured ASPE value is less than half of the ASPE value without the aluminum sheet, and then use the graphical or computational method to find the half-value layer.
5.5.5.2 5.5.2 Method 2: Direct measurement by multifunction dosimeter5.5.2.1 The half-value layer of the useful harness can also be measured directly by a multifunction digital dosimeter, with the same geometric conditions as in 5.2.1-5.2.4.
5.5.2.2 Setting up the 13-step device with the usual tube voltages and exposures, and directly recording the half-value layer as displayed by the dosimeter. reading.
5.5.2.3 When there is disagreement with the results, the aluminum chip method (5.5.1.1 to 5.5.1.4) should be used to remeasure.
5.5.6 5.6 High-contrast resolution5.6.1 Tests may be performed with wire-pair cards or molded bodies with embedded wire-pair test cards.
5.6.2 For intraoral machines, the wire pair card or test module is placed close to the exit of the beam limiting cylinder with its plane perpendicular to the center axis of the main beam. The test schematic is shown in Fig. B.4.
5.6.3 For panoramic photography function of the outboard machine, place the wire pair card or test module in the center of the head rest, and make the center axis of the main beam perpendicular to the plane of the test module. 0.8mm Cu is placed at the outlet of the X-ray bulb as an additional attenuation layer. The test diagram is shown in Figure B.5.
5.6.4 For the craniography function of the extra-oral machine, place the pair of cards or the test module in the location of the clinical examinee's head, and the center axis of the main beam is perpendicular to the plane of the test module, and 0.8mmCu is placed at the outlet of the X-ray bulb tube as an additional attenuation layer. A schematic diagram of the test is shown in Figure B.6.
5.6.5 Exposure is performed according to the test procedure and method recommended by the equipment manufacturer, or by setting up the usual adult exposure conditions of the equipment.5.6.6 The image is read on a high-resolution monitor, and the number of pairs of lines that can be resolved is observed.
5.5.7 5.7 Low-contrast resolution5.7.1 Tests are performed using a low-contrast resolution module.
5.7.2 Test geometric conditions are the same as 5.6.2 to 5.6.4.
5.7.3 Exposure is performed according to the test procedure and method recommended by the equipment manufacturer, or by setting the equipment's common adult exposure conditions.
5.7.4 Read the image on a high-resolution monitor and observe the smallest amount of low-contrast detail that can be resolved.
6 Appendix 6.1 Appendix A (normative appendix) quality control testing items and technical requirementsA.1? Dental X-ray equipment quality control testing items and technical requirements should be in accordance with the requirements of Table A.1.
Table A.1? Dental X-ray equipment testing items and technical requirements
Sequence
No.
Detection items
Type of equipment
Acceptance testing
Condition testing
Stability testing
Corresponding
Article
Decision Criteria
Decision Criteria
Decision Criteria
Decision Criteria
Decision Criteria
Decision Criteria
Decision Criteria
Decision Criteria
Judgment Criteria
Judgment Criteria
Cycle time
1
Deviation of tube voltage indication / %
In-port, out-port
Within ±10
Within ±10
Within ±10
Within ±10
Within six months
5.2
2
Output Repeatability/%
Intraoral machine
≤5
≤5
≤5
Three months
5.3
3
Load time deviation
Intraoral machine
Within ±5% or ±20ms,
Take the The greater
Within ±5% or ±20ms,
The greater
Within ±5 or ±20ms,
The greater
Three months
5.4
Extra-oral machine
Within ±(5%+50ms)
±(5%+50ms)
Within ±(5%+50ms)
Within ±(5%+50ms)
Within ±(5%+50ms)
Within ±(5%+50ms)
Within ±(5%+50ms)
±(5%+50ms)
Within
±(5%+50ms)
Within
Three months
4
Useful harness half-value layer/mm Al
Intra-port machine, Extra-port machine
Not less than the value stipulated in Table A.2
Not less than the value stipulated in Table A.2
5.5
5
High contrast resolution/(lp/mm)
Digital imaging device
≥2
≥2
≥2
Six months
5.6
6
Low Contrast ResolutionDigital Imaging Device
Resolves 1mm Diameter Hole in 0.5mm Thick Aluminum Plate
Resolves 1mm Diameter Hole in 0.5mm Thick Aluminum Plate
Six Months
6 months
5.6
≥2
≥2
6 months
5.6
5.6
≥2
5.6
5.6
6 months
6
6
65.7
A.2 Dental X-ray equipment half-value layer should be in accordance with the provisions of GB 9706.12, see Table A.2.
Table A.2 Half-value layer of dental X-ray equipment
Serial number
Type of application
X-ray tube voltage
kV
Minimum first half-value layer
Normal range of use
Selected value
mm Al
1
Dental application with intraoral machine
60
1.5
60-70
70
1.5
60
1.8
70
2.1
60 to 90
80
2.3
90
2.5
2
Other dental applications
60
1.3
60 to 70
70
1.5
60
1.8
70
2.1
80
2.3
90
2.5
60 to 125
100
2.7
110
3.0
120
3.2
125
3.3
6.2 Appendix B (Normative Appendix) Test Schematic Diagrams For the test schematics for the in-port unit and the out-port unitSee Fig. B.1 to Fig. B.6.
Description:
① - ball tube focal point; ② - beam limiting cylinder; ③ - half-value layer test aluminum sheet;
④ --④ - image receiver plane;
⑤ - position of dosimeter detector when testing tube voltage and output repeatability;
⑥ - position of dosimeter detector when testing half-value layer.
Figure B
Figure B.1: Schematic diagram of tube voltage, output reproducibility and half-value layer testing in dental port
Description:
① - image receiver plane; ② - secondary diaphragm;
③ - half-value layer testing aluminum sheet;
⑤ - position of dosimeter detector during testing of tube voltage and output reproducibility; ⑥ - position of dosimeter detector during testing of half-value layer. -- half-value layer test aluminum sheet; ④ -- dosimeter detector; ⑤ -- primary diaphragm;
⑥ -- X-ray bulb. -X-ray bulb tube.
Figure B.2 Schematic diagram of dental panoramic tube voltage and half-value layer test
Description:
① - image receiver plane; ② - secondary diaphragm;
③ - half-value layer test aluminum sheet; ④ - dosimeter detector; ⑤ - primary diaphragm;
⑥ - X-ray bulb tube. -- half-value layer test aluminum sheet; ④ -- dosimeter detector; ⑤ -- primary diaphragm;
⑥ -- X-ray bulb. -X-ray bulb tube.
Figure B.3 Schematic diagram of dental cephalometric tube voltage and half-value layer test
Description:
① - X-ray bulb tube; ② - beam limiting cylinder;
⑧ -- additional attenuation layer (6 mm Al) and resolution detection module; ④ -- image receiver plane.
Figure B.4 Schematic diagram of the resolution test of the dental intraoral machine
Description:
① - image receiver plane; ② - secondary diaphragm;
③ - additional attenuation layer (0.5 mm Al);
⑤ - primary diaphragm; ⑥ - X-ray bulb tube.
Figure B.5 Schematic diagram of the resolution test for dental panoramic photography
Description:
① - image receiver plane; ② - secondary diaphragm;
⑧ - additional attenuation layer (0.8 mmCu); ⑦ - X-ray bulb. -additional attenuation layer (0.8 mmCu); ④ -resolution detection module;
⑤ - primary diaphragm; ⑥ - X-ray bulb tube.
Figure B.6 Schematic diagram of dental cephalography resolution test
6.3 Appendix C (Informative Appendix) Test Module ExampleAn example of a dental X-ray equipment quality control test module is shown in Figure C.1. A high-resolution test card is embedded in the test module, and there are holes with diameters of 1 mm, 1.5 mm, 2 mm, and 2.5 mm in a 0.5 mm aluminum plate. for low-contrast resolution testing. In order to measure the dose of the device's image receiver, an additional attenuation layer of 6mm aluminum is added to this module. The upper part of the module consists of a center ring with different cone sizes and an attenuation layer of 6 mm aluminum plate; the middle part of the module contains the high contrast resolution test card and the test aluminum plate with the low contrast resolution holes; the lower part of the module has a socket for the dosimeter detector or the intraoral machine image receiver.
Description:
① - Dental harness barrel center marking;
② - Additional attenuation layer/body module (6. Omm aluminum);
③ - High contrast resolution module (6. Omm aluminum);
③ - High contrast resolution module (6. Omm aluminum). -high contrast resolution module (1.6 lp/mm to 3.0 lp/mm for digital machines); ④ -low contrast resolution module;
⑤ -module body reserved for dosimeter detector or intraoral machine image receiver position; ⑥ - basic mold body.
Figure C.1? Example of dental X-ray equipment quality control testing module
6.4 Appendix D (Informative Appendix) Equipment and appliances required for quality control testingThe equipment and appliances required for quality control testing of dental X-ray equipment are shown in Table D.1.
Table D.1? Equipment and appliances required for quality control testing of dental X-ray equipment
No.
Name< /p>
No.
Name
Specification Requirements
1
Tube Voltage Measurement Instrument
Calibrated Digital High Voltage Meter for Diagnostic Purposes
2
Dosimetric Measurement Instrument
Calibrated Dosimetry for Small Volume Detectors
3
High-Contrast Resolving Power Test Module<
Dental X-ray equipment for digital imaging: 1.6 lp/mm to 3.0 lp/mm
4
Low-contrast resolution test module
Shall consist of at least a 0.5-mm-thick perforated aluminum sheet with round holes of 1-mm, 1.5-mm, 2-mm, and 2.5-mm diameters
5
5<
Aluminum
Aluminum purity should not be less than 99.5%, the thickness of the dimensional error should be within ± 0.1mm
6
irradiation field detection tools
such as non-developing film, detection plate or film dark box combination
7
Measurement of the tape measure
length of not less than 2m, the accuracy of ±1mm
8
Tape for fixing
7 References
[1] IEC 60601265:2012. Part 265: Particular requirements for the basic safety and essential performance of dental intraoral Xray equipment
[2] IEC 60601263:2012. International Electrotechnical Commission. Medical electrical equipment Part 263: Particular requirements for the basic safety and essential performance of dental extraoral X-ray equipment
[2] IEC 60601263:2012. performance of dental extraoral X-ray equipment
[3] GB 9706.32000 Medical electrical equipment Part 2: Safety-specific requirements for high-voltage generators of diagnostic X-ray generating devices
[4] GB 9706.121997 Medical electrical equipment Part 1: General requirements for safety III. Concurrent standards General requirements for radiation protection of diagnostic X-ray equipment
[5]? YY/T 00102008 Dental X-ray machine special technical conditions
[6]? YY/T 07952010 Dental X-ray digital tomography equipment special technical conditions
[7] GB/T19042.42005 Evaluation of the medical imaging sector and routine testing Part 34: Dental X-ray equipment imaging performance acceptance test
Human Body Surface Area Calculator BMI Index Calculation and Evaluation Female Safe Period Calculator Due Date Calculator Normal Weight Gain During Pregnancy Medication Safety Classification (FDA) Five Elements and Eight Characteristics Adult Blood Pressure Evaluation Body Temperature Level Evaluation Diabetes Dietary Recommendations Clinical Biochemistry Common Unit Conversions Basal Metabolic Rate Calculator Sodium Replacement Calculator Iron Replacement Calculator A Quick Look at Commonly Used Latin Abbreviations for Prescriptions A Quick Look at Commonly Used Symbols in Pharmacokinetics Effective Plasma Osmolality Calculator Ethanol Intake CalculatorEncyclopedia of Medicine, right now! Calculator!
8 Full text of the standard