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YY/T 0010-2020: Particular specifications for dental intra-oral X-ray equipment
Status: Valid YY/T 0010: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0010-2020 | English | 259 |
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Particular specifications for dental intra-oral X-ray equipment
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YY/T 0010-2020
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| YY/T 0010-2008 | English | 359 |
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Particular specifications for X-ray unit for oral cavity
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YY/T 0010-2008
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| YY/T 0010-2002 | English | RFQ |
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X-ray unit for oral cavity
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YY/T 0010-2002
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| YY 0010-1990 | English | 399 |
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(Oral X-ray machine)
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PDF similar to YY/T 0010-2020
Basic data | Standard ID | YY/T 0010-2020 (YY/T0010-2020) | | Description (Translated English) | Particular specifications for dental intra-oral X-ray equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 14,192 | | Date of Issue | 2002-01-01 | | Date of Implementation | 2021-06-01 | | Issuing agency(ies) | State Drug Administration | YY/T 0010-2020: Particular specifications for dental intra-oral X-ray equipment---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Particular specifications for dental intra-oral X-ray equipment
ICS 11.040.50C43
People's Republic of China Pharmaceutical Industry Standards
YY/T 0010-2020 replaces YY/T 0010-2008
Released on 2020-06-30
Implementation of 2021-06-01
Issued by the National Medical Products Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0010-2008 "Specific technical conditions for dental X-ray machines."
Compared with YY/T 0010-2008, the main technical parameters of this standard are as follows.
---Modified the standard name, and changed the "special technical requirements for oral X-ray machines" to "special technical specifications for intraoral imaging dental X-ray machines"
Pieces".
---Modified the scope (see Chapter 1, Chapter 1 in the.2008 edition);
---Modified terms and definitions (see Chapter 3, Chapter 3 in the.2008 edition);
---Modified the classification (see 4.1, 4.1 in the.2008 edition);
---Modified the composition (see 4.2, 4.2 in the.2008 edition);
---Modified the adjustment range requirements of the X-ray tube voltage [see 5.3.1a), 5.3.1a) in the.2008 edition];
---Modified the loading time requirements (see 5.3.3, 5.3.3 in the.2008 edition);
---Modified the adjustment range requirements of the current time product [see 5.3.4a), 5.3.4a) in the.2008 edition];
---Modified the limit of the distance from the focus to the skin (see 5.4.2, 5.4.2 in the.2008 edition);
---The relevant content of the oral and maxillofacial panoramic X-ray machine in the original standard has been deleted (see 4.1, 4.2, 5.3, 5.4, and 5.4 in the.2008 edition)
5.5);
---Added relevant requirements for handheld dental X-ray machines (see 5.3.6);
---Increase the requirements for line-pair resolution, low-contrast resolution, and image uniformity for products with electronic X-ray image receivers
And test methods (see 5.4.3, 5.4.4, 5.4.5 and 6.4.3, 6.4.4, 6.4.5);
--- Added Appendix A.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is organized by the National Medical Electrical Appliance Standardization Technical Committee Medical X-ray Equipment and Appliances Sub-Technical Committee (SAC/TC10/
SC1) Centralized.
Drafting organizations of this standard. Liaoning Medical Device Inspection and Testing Institute, Taizhou Zhonglian Medical Technology Co., Ltd., National Medical Products Administration
Medical Device Technology Review Center, Carestream Dental Technology (Shanghai) Co., Ltd.
The main drafters of this standard. Wang Yanan, Zhang Qing, Sun Weijun, Zhang Yong, Zhang Futao.
The previous releases of this standard are as follows.
1 Scope
This standard specifies the terms and definitions, system composition, requirements and test methods of dental X-ray machines for intraoral imaging (hereinafter referred to as dental machines).
This standard applies to X-ray machines that use intraoral X-ray image receivers to take X-ray pictures of teeth.
This standard does not apply to X-ray machines that use external X-ray image receivers for imaging.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB 9706.1 Medical electrical equipment Part 1.General requirements for safety
GB 9706.3-2000 Medical electrical equipment Part 2.Special requirements for the safety of high-voltage generators for diagnostic X-ray generators
GB 9706.11 Medical electrical equipment Part 2.Special requirements for the safety of medical diagnostic X-ray source components and X-ray tube components
GB 9706.12 Medical electrical equipment Part 1.General requirements for safety 3.Parallel standard diagnostic X-ray equipment radiation protection
General requirements
GB 9706.14 Medical electrical equipment Part 2.Special requirements for the safety of auxiliary equipment of X-ray equipment
GB 9706.15 Medical Electrical Equipment Part 1.General Requirements for Safety 1.Collateral standard. safety requirements for medical electrical systems
GB/T 19042.4-2005 Evaluation and routine test of medical imaging department Part 3-4.Imaging performance of dental X-ray equipment
Acceptance test
YY 0505 Medical Electrical Equipment Part 1-2.General Safety Requirements Collateral Standard. Electromagnetic Compatibility Requirements and Tests
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
3 Terms and definitions
GB 9706.1, GB 9706.3-2000, GB 9706.11, GB 9706.12, GB 9706.14, GB 9706.15, GB/T 19042.4-2005,
The terms and definitions defined in YY 0505, YY/T 0291 and the following apply to this document.
3.1
It is related to dental X-ray imaging, in which the X-ray image receiver is entirely or partly located in the oral cavity.
3.2
An X-ray machine that uses an intraoral X-ray image receiver to take X-ray pictures of teeth.
3.3
X-ray image receiver using electronic conversion method.
3.4
The movable mechanism connected with the X-ray tube head in the dental X-ray machine.
3.5
X-ray tube assembly including high-voltage transformer assembly.
4 System configuration
4.1 The classifications are as follows according to the structure, installation and use mode.
a) Fixed;
b) Mobile;
c) Portable;
d) Handheld.
4.2 The composition of the dental X-ray machine is shown in Figure 1.
Dental X-ray machines generally consist of X-ray generators, telescopic arms and other accessories, and may be equipped with X-ray image receivers.
equipment.
Figure 1 The composition of the dental X-ray machine
5 requirements
5.1 Working conditions
5.1.1 Environmental conditions
Unless otherwise specified, the working environment conditions of the dental machine should meet.
a) Ambient temperature. 10℃～40℃;
b) Relative humidity. 30%～75%;
c) Atmospheric pressure. 700hPa~1060hPa.
5.1.2 Power supply conditions
The working power supply conditions of the dental machine should meet.
a) The power supply voltage and the number of phases specified by the manufacturer, and the fluctuation of the grid voltage should not exceed ±10% of the nominal value;
b) Power frequency. 50 Hz ± 1 Hz;
c) The power supply resistance specified by the manufacturer [The applicable power supply resistance should not be less than 10.2.2a in GB 9706.3-2000) Table 101
Specified value];
d) The power supply capacity specified by the manufacturer.
5.2 Electric power
5.2.1 Maximum output power
The manufacturer shall specify the corresponding combination of X-ray tube voltage and X-ray tube current that results in the maximum output electric power.
5.2.2 Nominal electric power
The manufacturer shall stipulate that when the loading time is 0.1s and the X-ray tube voltage is 100kV, the dental unit can provide the unit of kW
The maximum constant electric power output is given as the nominal electric power. If this value cannot be pre-selected, the X-ray tube closest to 100kV can be used
The voltage value and the closest loading time value, but should not be shorter than 0.1s.
The nominal electric power should be given together with the combination of X-ray tube voltage and X-ray tube current and loading time.
5.3 Loading factors and control
5.3.1 X-ray tube voltage
The voltage of the X-ray tube should meet the following requirements.
a) The manufacturer shall specify the adjustment range and method of the X-ray tube voltage, and shall comply with the following requirements. tube voltage can be fixed
The tube voltage can be adjusted in two ways, the tube voltage should not be less than 60kV; if the step adjustment is adopted, the adjacent tube voltage increase should not be
More than 5kV;
b) The manufacturer shall specify the deviation of the X-ray tube voltage value, but at least it shall meet the requirements of 50.103.1 in GB 9706.3-2000.
5.3.2 X-ray tube current
X-ray tube current should meet the following requirements.
a) The manufacturer shall specify the adjustment range and adjustment method of the X-ray tube current, and shall comply with the following regulations. tube current solid
Fixed, tube current step-by-step adjustment, or current time product adjustment three ways; the maximum tube current selection range should be ≤10mA;
b) The manufacturer shall specify the deviation of the current value of the X-ray tube, but it shall at least meet the requirements of 50.103.2 in GB 9706.3-2000.
5.3.3 Loading time
The loading time should meet the following requirements.
a) The manufacturer shall specify the adjustment range and adjustment method of the loading time; the number of bins shall be selected according to the priority number system R10 or R20 series;
b) The manufacturer should specify the deviation of the loading time value, but it should at least meet the requirements of 50.103.3 in GB 9706.3-2000.
5.3.4 Current time product
If there is a current time product indicator, it should meet the following requirements.
a) The manufacturer shall specify the adjustment range and adjustment method of the current time product, and shall meet the following requirements. 5.3.2a) and
5.3.3a) Requirements for the combination of tube current and loading time; for each tube voltage, the ratio of the highest to lowest current time product should be
Not less than 16;
b) The manufacturer should specify the deviation of the current time product value, but at least it should meet the requirements of 50.103.4 in GB 9706.3-2000.
5.3.5 Anti-overload
The dental machine should have anti-overload measures to ensure that the selection of loading factors will not exceed the rated capacity of the X-ray tube. Should conform to the instruction manual
The maximum load factor combination given in.
5.3.6 Handheld dental machine
5.3.6.1 Attached documents
The hand-held dental machine should be provided in the accompanying documents.
a) The leakage radiation and stray radiation value to the operator;
b) Guidance to avoid image degradation caused by the actions of X-ray source components during loading;
c) Illustrative drawings and dimensions of the designated effective occupied area;
d) The method specified by the manufacturer to evaluate the leakage of radiation and stray radiation to the operator, and the method of image degradation due to actions
Noodle method.
5.3.6.2 Leakage radiation on the surface of the handheld dental machine
The surface that can be touched by the handheld dental machine (excluding the X-ray outlet), the leakage radiation value should not be greater than 0.25 mg/h.
5.4 Imaging performance
5.4.1 Limitation and calibration of X-ray beam
The accuracy of the X-ray field size marked and recorded on the equipment and the actual size of the X-ray field should meet the error specified by the manufacturer.
5.4.2 Distance from focus to skin
The distance from the focal point of the dental machine to the skin should not be less than 20 cm.
5.4.3 Line pair resolution
For dental machines with electronic X-ray image receivers, the manufacturer shall specify the line pair resolution.
5.4.4 Low contrast resolution
For dental machines with electronic X-ray image receivers, the manufacturer shall specify low contrast resolution.
5.4.5 Image uniformity...
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