Traditional Culture Encyclopedia - Photography major - Brief introduction of WS 58 1—20 17 "Quality Control and Inspection Specification for Dental X-ray Equipment".
Brief introduction of WS 58 1—20 17 "Quality Control and Inspection Specification for Dental X-ray Equipment".
English reference specification for quality control test of dental X-ray equipment
3 basic information ICS 13.280 C 57
China people * * and the national health industry standard WS 581-20 17 "Standard for Quality Control and Inspection of Dental X-ray Equipment" was compiled by China people * * and promulgated by the National Health and Family Planning Commission of the People's Republic of China on October 27th, 20/KLOC-0.
This standard 4. 1 ~ 4.7 is mandatory, and others are recommended.
This standard was drafted according to GB/T1.1-2009.
Drafting units of this standard: Institute of Radiation Protection and Nuclear Safety Medicine of China Center for Disease Control and Prevention, Beijing Center for Disease Control and Prevention, Stomatological Hospital of Peking University, Fujian Provincial Center for Occupational Diseases and Chemical Poisoning Prevention and Control, and Beijing Chaoyang District Center for Disease Control and Prevention.
Main drafters of this standard: Xu Hui, Yue Baorong, Fan, Wei Kedao, Wang Jianchao, Lou Yun, Feng, Wei Weiqi, Zhao Hongfeng and Li Gang.
Standard text quality control test specification for dental X-ray equipment
5. 1 Scope 1 This standard specifies the requirements and methods for quality control and testing of dental X-ray equipment.
This standard is applicable to the quality control test of dental X-ray equipment with intraoral X-ray image receiver and dental X-ray equipment with extraoral X-ray image receiver.
This standard does not apply to the quality control detection of oral CT.
5.2 2 Normative reference documents The following documents are very important for the application of this document. For dated reference documents, only dated version is applicable to this document. For undated reference documents, the latest version (including all revisions) is applicable to this document.
GB 9706. 12？ Medical electrical equipment-Part 1: General requirements for safety. General requirements for radiation protection of parallel standard diagnostic X-ray equipment
5.3 3 Terms and Definitions The following terms and definitions apply to this document.
3. 1
Dental x-ray equipment
X-ray equipment for dental imaging.
3.2
Dental intra-oral X-ray equipment
Intraoral machine
X-ray machine with oral X-ray image receiver for taking X-ray images of teeth.
3.3
Dental extraoral X-ray equipment
Extraoral machine
An X-ray machine with an extraoral X-ray image receiver is used to take X-ray images of teeth and jaws.
Note: Extraoral machine generally includes panoramic X-ray photography and skull photography.
5.4 4 General requirements for quality control testing 4. 1 After the dental X-ray equipment is installed and overhauled, it shall be accepted and tested according to the technical requirements agreed in this standard or the procurement contract; Normal use of dental X-ray equipment should be tested as required, and the test should be conducted once a year. The dental X-ray equipment in use should be tested regularly for stability. See table A. 1 in appendix a for the period of stability test. When the deviation between the stability test results and the baseline value is greater than the control standard, and the reason cannot be judged, the state test should also be carried out.
4.2 Acceptance shall be entrusted to a qualified inspection agency. Legal persons, manufacturers and testing institutions cooperate with each other. National inspection shall be entrusted to a qualified inspection agency. The stability test should be carried out by the medical unit itself or by a qualified institution.
4.3 The acceptance test results of newly installed dental X-ray equipment shall conform to the product performance indicators listed in the accompanying documents and the technical terms in the contract or agreement between both parties, but shall not be lower than the requirements of this standard. Items not specified by the supplier shall meet the requirements of this standard.
4.4 The quality control test items of dental X-ray equipment shall cover the items specified in this standard, and the corresponding test items of the tested equipment that have no function or cannot meet the test conditions shall be explained in the test report.
4.5 See Chapter 5 for the quality control test items and test methods of dental X-ray equipment, and its evaluation shall meet the requirements of Table A. 1 in Appendix A. The test results are equal to or better than the index values specified in this standard.
4.6 Quality control inspection shall have inspection records, and inspection reports shall be issued for acceptance and status inspection. The basic contents of the inspection report shall include: basic information and equipment information of the inspected unit, inspection items and methods, necessary inspection conditions, inspection results and corresponding standard requirements.
4.7 See Appendix B for the schematic diagram of quality control test of dental X-ray equipment.
4.8 See Appendix C for an example of the quality control test module of dental X-ray equipment.
4.9 See Table D. 1 in Appendix D for the equipment and instruments needed for quality control test of dental X-ray equipment.
5.5 5 Quality control testing methods 5.5. 1 5. 1 Requirements for testing instruments and molds 5. 1. 1 Testing instruments shall be verified or calibrated according to relevant regulations, and the results shall be traceable.
5. 1.2 digital high-voltage measuring instrument detects the tube voltage, and the detection adopts non-invasive method.
5. 1.3 For the standard aluminum absorber used to detect the half-value layer, the purity of aluminum should be no less than 99.5%, and the thickness and dimension error should be within 0.1mm. The dimension of aluminum sheet should at least completely cover the sensitive area of dosimeter detector.
5. 1.4 The alignment range of the high contrast resolution test module shall at least meet the following requirements: digital imaging dental X-ray equipment1.6lp/mm ~ 3.0lp/mm. ..
5. 1.5 The low contrast resolution test module shall at least include an aluminum plate with a thickness of 0.5mm, and there are circular holes with diameters of1.0mm, 1.5mm, 2.0mm and 2.5mm on the aluminum plate. ..
5.5.2 5.2 Deviation of tube voltage indication 5.2. 1 Digital high-voltage measuring instrument shall be set according to the type of high-voltage generator and the detection parameters of the tested equipment.
5.2.2 For the intra-oral machine, place the kV detector near the exit of the beam limiter, with its effective measuring point located at the central axis of the main beam and the detector surface perpendicular to the central axis of the main beam to ensure that the X-ray beam completely covers the detector. See figure B. 1 for the schematic diagram of the test.
5.2.3 For the panoramic photography function of an external camera, the position of shooting field of view can be found on the image receiver with undeveloped film first, and the kV detector is placed on the surface of the image receiver shell, and its effective measuring point is located on the central axis of the main beam, so that the detector surface is perpendicular to the central axis of the main beam. See figure B.2 for the schematic diagram of the test.
5.2.4 For the head photography function of the external camera, you can first find the shooting field position outside the sub-optical circle with undeveloped film, and place the kV detector outside the sub-optical circle, with its effective measuring point located at the central axis of the main beam and the detector plane perpendicular to the central axis of the main beam. See figure B.3 for the schematic diagram of the test.
5.2.5 At the time of acceptance, set the lowest, middle and highest pipe pressures of the adjustable pipe pressure equipment; When this condition is detected, it can be detected through the common gear of the device. Repeat the exposure for at least 3 times, record the tube voltage measured each time, and calculate its average value.
5.2.6 Calculate the relative deviation of the indicated value of tube voltage according to formula (1) and compare it with the requirements in Table A. 1 in Appendix A:
Among them:
The relative deviation of EV- tube voltage measurement;
—— Average value of tube voltage measurement, in kilovolts (kV);
V0—— the preset value of tube voltage, in kilovolts (kV).
5.5.3 5.3 Repeatability of output 5.3. 1 For the intra-oral machine, the dose detector is placed near the exit of the beam limiter, and its effective measuring point is located at the central axis of the main beam, and the detector surface is perpendicular to the central axis of the main beam, so as to ensure that the X-ray beam completely covers the detector. See figure B. 1 for the schematic diagram of the test.
5.3.2 Expose the equipment for five consecutive times under the exposure conditions of ordinary adults, record the dose value of each time, and calculate the repeatability of radiation output by Formula (2):
Among them:
CV—— coefficient of variation,%;
Ki—— the measured value of each radiation output, in milligy/milliampere second (MGY/ mass);
—— the average value of N radiation output measurements, with the unit of MGY/ milliampere second;
N—— Total measurement times of radiation output.
5.5.4 5.4 The loading time deviation is 5.4. 1 The geometric conditions of the test are the same as 5.2. 1 ~ 5.2.4.
5.4.2 Expose the equipment for three consecutive times under the exposure conditions of ordinary adults, record the measurement time displayed by dosimeter after each exposure, and calculate the average value.
5.4.3 Compare the average load time test value with the equipment display value.
5.4.4 Calculate the deviation of loading time according to Formula (3):
Among them:
Et-loading time deviation;
Ti—— the average value of loading time measurement, in milliseconds (ms);
T0—— preset loading time, in milliseconds (ms).
5.5.5 Half-value layer of useful wire harness 5.5.5. 1 5.5. 1 method 1: aluminum sheet method 5.5. 1. 1 Test geometry conditions are the same as 5.2.1~.
5.5. 1.2 Set the condominium voltage of 1 ~ 3 equipment and expose it, and record the specific kinetic energy value of air.
5.5. 1.3 Put the aluminum sheet at the X-ray exit of the bulb tube, keep the exposure conditions unchanged, and measure the air specific release kinetic energy of aluminum sheets with different thicknesses.
5.5. 1.4 gradually increase the thickness of aluminum sheet until the measured specific kinetic energy rate of air is less than half that of air without aluminum sheet, and use it as a graphic method or calculation method to find the half-value layer.
5.5.5.2 5.5.2 Method 2: Multi-function dosimeter direct measurement method 5.5.2. 1 Half-value layer of useful wire harness can also be directly measured by multi-function digital dosimeter, and the test geometry conditions are the same as 5.2. 1 ~ 5.2.4.
5.5.2.2 sets the common tube voltage of 13 equipment and exposes it, and directly records the half-value layer reading displayed by the dosimeter.
If 5.5.2.3 disagrees with the results, the aluminum sheet method (5.5.1.1~ 5.5.1.4) should be used for remeasurement.
5.5.6 5.6 High contrast resolution 5.6. 1 Inter-line cards or embedded wires can be used to detect the mold body of the test card.
5.6.2 For the intraoral machine, place the calibration card or test module near the exit of the beam limiter, and make its plane perpendicular to the central axis of the high beam. See figure B.4 for the schematic diagram of the test.
5.6.3 For the panoramic photography function of the external camera, place the line pair card or test module in the center of the headrest, and the central axis of the main beam is perpendicular to the plane of the test module. 0.8mmCu was placed at the exit of X-ray tube as an additional attenuation layer. See figure B.5 for the schematic diagram of the test.
5.6.4 For the head photography function of the extraoral machine, place the linear alignment card or test module at the position of the clinical subject's head, and the central axis of the main beam is perpendicular to the plane of the test module. 0.8mmCu was placed at the exit of X-ray tube as an additional attenuation layer. See figure B.6 for the schematic diagram of the test.
5.6.5 Expose the equipment according to the test steps and methods recommended by the equipment manufacturer, or set the common adult exposure conditions of the equipment. 5.6.6 Read the image on the high-resolution display and observe the number of distinguishable line pairs.
5.5.7 5.7 Low contrast resolution 5.7. 1 detected by low contrast resolution phantom.
5.7.2 The geometric conditions of the test are the same as 5.6.2 ~ 5.6.4.
5.7.3 Expose the equipment according to the test steps and methods recommended by the equipment manufacturer, or set the common adult exposure conditions of the equipment.
5.7.4 Read the image on the high-resolution display and observe the low-contrast details with the lowest resolution.
6 appendix 6. 1 appendix a (normative appendix) quality control inspection items and technical requirements A. 1? The quality control test items and technical requirements of dental X-ray equipment shall meet the requirements of Table A. 1.
Table A. 1? Testing items and technical requirements of dental X-ray equipment
order
figure
test item
device type
check before acceptance
State detection
Stability detection
consistent
clause
standard
standard
standard
circulate
1
Tube voltage indication deviation/%
Intraoral machine
Within 10
Within 10
Within 10
six months
5.2
2
Output repeatability/%
Intraoral machine
≤5
≤5
≤5
three months
5.3
three
Loading time deviation
Intraoral machine
In 5% or 20 milliseconds,
Take a bigger one.
In 5% or 20 milliseconds,
Take a bigger one.
In 5 or 20 milliseconds,
Take a bigger one.
three months
5.4
Extraoral machine
Within (5%+50ms)
(5%+50ms)
inside
(5%+50ms)
inside
three months
four
Half-value layer of useful wire harness/mm aluminum
Intraoral machine
Not less than the value specified in table a.2.
Not less than table a.2.
rating
—
5.5
five
High contrast resolution /(LP/mm)
Digital imaging equipment
≥2
≥2
≥2
six months
5.6
six
Low contrast resolution
Digital imaging equipment
0.5mm thick aluminum plate can be distinguished.
Upper 1 mm diameter hole
1mm can be distinguished on 0.5mm thick aluminum plate.
Diameter hole
1mm can be distinguished on 0.5mm thick aluminum plate.
Diameter hole
six months
5.7
A.2 The half-value layer of dental X-ray equipment shall conform to the provisions of GB 9706. 12, as shown in Table A.2. ..
Table A.2 Half-value layer of dental X-ray equipment
serial number
Application type
X-ray tube voltage
kilovolt
Minimum first half-value layer
Normal use range
Selected value
Millimeter aluminum
1
Dentistry with oral machine should
use
60
1.5
60~70
70
1.5
60
1.8
70
2. 1
60~90
80
2.3
90
2.5
2
Other dental applications
60
1.3
60~70
70
1.5
60
1.8
70
2. 1
80
2.3
90
2.5
60~ 125
100
2.7
1 10
3.0
120
3.2
125
3.3
6.2 Appendix B (Normative Appendix) Test Schematic Diagram See Figure B. 1 ~ Figure B.6 for the test schematic diagram of the intraoral machine and the extraoral machine.
Description:
(1)-the focus of the light bulb; ② —— beam limiting tube; ③ —— Half-value layer test aluminum sheet;
④ —— Image receiver plane;
⑤ —— the position of dosimeter detector when testing tube voltage and output repeatability; ⑥ —— Position of dosimeter detector when measuring half-value layer.
Figure B. 1? Schematic diagram of voltage, output repeatability and half-value layer test of dental intraoral machine tube
Description:
① —— Image receiving plane; ② —— Secondary diaphragm;
③ —— Half-value layer test aluminum sheet; ④ —— dosimeter detector; ⑤ —— Primary diaphragm;
⑥-X-ray tube.
Fig. B.2 schematic diagram of voltage and half-value layer test of dental panoramic photography tube
Description:
① —— Image receiving plane; ② —— Secondary diaphragm;
③ —— Half-value layer test aluminum sheet; ④ —— dosimeter detector; ⑤ —— Primary diaphragm;
⑥-X-ray tube.
Fig. B.3 schematic diagram of voltage and half-value layer test of dental photography tube
Description:
①-X-ray tube; ② —— beam limiting tube;
⑧ Additional attenuation layer (6 mm Al) and resolution detection module; ④ —— Image receiving plane.
Figure B.4 Schematic diagram of resolution test of dental intraoral machine
Description:
① —— Image receiving plane; ② —— Secondary diaphragm;
③ —— Additional attenuation layer (0.8 mmcu); ④ —— Resolution detection module;
⑤ —— Primary diaphragm; ⑥-X-ray tube.
Fig. B.5 schematic diagram of resolution test of dental panoramic photography.
Description:
① —— Image receiving plane; ② —— Secondary diaphragm;
⑧ —— Additional attenuation layer (0.8 mmcu); ④ —— Resolution detection module;
⑤ —— Primary diaphragm; ⑥-X-ray tube.
Fig. B.6 schematic diagram of dental photography resolution test.
6.3 See Figure C. 1 for an example of the test module in Appendix C (informative appendix) for an example of the quality control test module for dental X-ray equipment. A high-resolution test card is embedded in the test mold, and a 0.5mm aluminum plate has round holes with diameters of 1mm, 1.5mm, 2mm and 2.5mm for low-contrast resolution test. In order to measure the dose of the image receiver of the device, an aluminum attenuation layer of 6mm was added to the mold. The upper part of the die body consists of central rings with different cone sizes and 6mm aluminum plate attenuation layer; The middle part of the mold body is a high contrast resolution test card and a low contrast resolution round hole test aluminum plate; The lower part of the mold body is provided with a socket for dosimeter detector or intraoral image receiver.
Description:
① —— center mark of dental wiring harness tube;
② —— Additional attenuation layer/phantom (6. Omm aluminum);
③ —— high contrast resolution module (digital computer1.6lp/mm ~ 3.0lp/mm); ④ Low contrast resolution module;
⑤ —— The position of dosimeter detector or image receiver of the oral machine is reserved in the phantom; ⑥-Basic motif.
Figure C. 1? Example of quality control test module for dental X-ray equipment
6.4 Appendix D (informative appendix) Equipment and appliances needed for quality control inspection of dental X-ray equipment are shown in Table D. 1.
Table D. 1? Equipment and appliances needed for quality control and testing of dental X-ray equipment
figure
name
Specification requirements
1
Tube voltage measuring instrument
Calibrated digital high voltage measuring instrument for diagnosis
2
Dosimeter
Calibrated small volume detector dosimeter
three
High contrast resolution test module
Digital imaging dental X-ray equipment:1.6lp/mm ~ 3.0lp/mm.
four
Low contrast resolution test module
It shall include perforated aluminum plates with a thickness of at least 0.5mm and diameters of 1 mm,1.5mm, 2mm and 2.5mm..
circular hole
five
aluminum sheet
The purity of aluminum should be no less than 99.5%, and the thickness dimension error should be within 0.65438 0 mm..
six
Radiation field detection tool
Such as undeveloped film, detection board or film cassette combination, etc.
seven
tape measure
The length is not less than 2m, and the accuracy is1mm.
eight
Adhesive tape for fixing
Reference [1] IEC 606065438. International electrotechnical commission. Medical electrical equipment-Part 265: Particular requirements for basic safety and basic performance of X-ray equipment in dental cavity.
[2] IEC 60601263: 2012 International Electrotechnical Commission. Medical electrical equipment-Part 263: Particular requirements for basic safety and basic performance of dental extraoral X-ray equipment.
[3] GB 9706.32000 Medical electrical equipment Part 2: Special requirements for the safety of diagnostic X-ray generators and high-voltage generators.
[4] GB 9706. 12 1997 Medical electrical equipment Part I: General safety requirements III. General requirements for radiation protection of parallel standard diagnostic X-ray equipment.
[5]? YY/T 00 102008 Special Specification for Oral X-ray Machine
[6]? YY/T 079520 10 Special specification for dental X-ray digital tomography equipment.
[7] GB/T 19042.42005 Evaluation and routine test of medical imaging department Part 34: Acceptance test of imaging performance of dental X-ray equipment.
Calculation and evaluation of body mass index index of human body surface area calculator safety period calculator expected date of delivery calculator Normal weight gain during pregnancy Drug safety classification (FDA) Five elements and eight characters Adult blood pressure evaluation Body temperature level evaluation Diabetes diet suggestion Clinical biochemical common unit conversion basal metabolic rate calculation Sodium supplement calculator Iron supplement calculator prescription common Latin abbreviations Quick check Pharmacokinetics common symbols Quick check Effective plasma osmotic pressure calculator Alcohol intake calculator.
Encyclopedia of medicine, count now!
The full text of standard 8
- Related articles
- Historical Evolution of Dashanzi Art District
- Wangfujing Railway Photography Circle
- How much is the ticket for Qujing Dream World?
- Narrative composition of stories in photos
- Huang Xiaoming and Deng Chao fought in secret for sixteen years. What did Sun Li do to make Xiaogang Feng decisively kick Deng Chao out?
- How can I make the photos of rainy days clearer and more beautiful!
- How did Tonghua cancel the trip to Weifang?
- How about Shanghai Maiguo Electronic Technology Co., Ltd.?
- Is traveling to the Arctic fun?
- How many kilometers is it from Xiapu to Huian?