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YY/T 0795-2022: Particular specification for dental cone-beam computed tomography equipment
Status: Valid YY/T 0795: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0795-2022 | English | 559 |
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Particular specification for dental cone-beam computed tomography equipment
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YY/T 0795-2022
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| YY/T 0795-2010 | English | 599 |
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Particular specification for oral cavity X-ray equipment for digital tomography
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YY/T 0795-2010
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PDF similar to YY/T 0795-2022
Basic data | Standard ID | YY/T 0795-2022 (YY/T0795-2022) | | Description (Translated English) | Particular specification for dental cone-beam computed tomography equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 27,229 | | Issuing agency(ies) | State Drug Administration | YY/T 0795-2022: Particular specification for dental cone-beam computed tomography 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 specification for dental cone-beam computed tomography equipment
ICS 11.040.50
CCSC43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0795-2010
Oral and maxillofacial cone beam computed tomography equipment
Special technical conditions
Published on 2022-05-18
Simultaneous implementation with GB 9706.1-2020
Released by the State Drug Administration
directory
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Composition 2
5 Requirements 2
6 Test method 5
Appendix A (Informative) Phantoms for Routine Assessment of Image Quality 11
Appendix B (Informative) Image Quality Quantitative Assessment Phantom 15
Appendix C (normative) Simplified determination of modulation transfer characteristics 18
Appendix D (normative) Contrast Noise Figure Calculation 20
Appendix E (Informative) Figure 21
Reference 23
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document replaces YY/T 0795-2010 "Special Operating Conditions for Oral X-ray Digital Tomography Equipment".
Compared with YY/T 0795-2010, except for structural adjustment and editorial changes, the main technical changes are as follows.
--- Modified the scope (see Chapter 1, Chapter 1 of the.2010 edition);
--- Modified normative references (see Chapter 2, Chapter 2 of the.2010 edition);
--- Modified terms and definitions (see Chapter 3, Chapter 3 of the.2010 edition);
--- Modified the composition (see Chapter 4, Chapter 4 of the.2010 edition);
--- Delete the requirements and test methods for image signal-to-noise ratio, reconstruction time and thickness of selected layers (see 5.4.1, 5.4.5, 5.4.6 of the.2010 edition
and 6.4.1, 6.4.5, 6.4.6);
--- Increased requirements and test methods for voxel size (see 5.4.4 and 6.4.4);
--- Added special requirements and test methods for children (see 5.5 and 6.5);
--- Delete the requirements for load-bearing (see 5.6 of the.2010 edition);
--- Removed the requirements for appearance (see 5.9 of the.2010 edition);
--- Increased the requirements and test methods for bone mineral density (see 5.7 and 6.7);
--- Modified the software function (see 5.8, 5.8 of the.2010 edition);
--- Added requirements and test methods for doses (see 5.9 and 6.9);
--- Increased requirements and test methods for external interlocking devices (see 5.10 and 6.10);
--- Added requirements and test methods for quality assurance (see 5.13 and 6.13);
--- Added supplementary requirements and test methods for random documents (see 5.14 and 6.14);
--- Modified the quantitative evaluation method of spatial resolution, low contrast resolution and uniformity (see 6.4).
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliances Sub-Technical Committee (SAC/TC10/
SC1) focal point.
This document is drafted by. Liaoning Provincial Institute of Medical Device Inspection, Medical Device Technology Review Center of the State Drug Administration, Hefei
Meiya Optoelectronics Technology Co., Ltd., Kawa Shengbang (Shanghai) Dental and Medical Equipment Co., Ltd., Shenzhen Fusen Technology Co., Ltd., Carestream
Asia Pacific Investment Management (Shanghai) Co., Ltd., Beijing Longview Instrument Co., Ltd.
The main drafters of this document. Sun Zhiyong, Zhang Qing, Zhang Jianjun, Zeng Jiajia, Lv Guangzhi, Zhang Futao, Wu Hongxin.
The previous versions of the standards replaced by this document are.
---YY/T 0795-2010.
Oral and maxillofacial cone beam computed tomography equipment
Special technical conditions
1 Scope
This document specifies the composition, requirements and tests of oral and maxillofacial cone beam computed tomography equipment (hereinafter referred to as oral CBCT).
method.
This document applies to oral CBCT equipment including the use of image intensifiers or flat panel detectors as image acquisition devices. this document
Not applicable to curved tomography and cephalometric photography parts of oral CBCT equipment, see YY/T 1732 for relevant requirements.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
For undated references, the latest edition (including all amendments) applies to this document.
GB 7247.1 Safety of Laser Products Part 1.Equipment Classification and Requirements
GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Safety
GB 9706.103-2020 Medical Electrical Equipment Part 1-3.General Requirements for Basic Safety and Essential Performance Collateral Standards.
Radiation protection of diagnostic X-ray equipment
GB 9706.228-2020 Medical Electrical Equipment Part 2-28.Basic Safety and Fundamentals of Medical Diagnostic X-ray Tube Assemblies
Can special requirements
GB 9706.254-2020 Medical Electrical Equipment Part 2-54.Basic Safety and Fundamentals of X-ray Photography and Fluoroscopy Equipment
Can special requirements
GB/T 10149 Terms and Symbols of Medical X-ray Equipment
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
YY/T 1466 Oral X-ray Digital Tomography Equipment Bone Densitometry Evaluation Method
YY 9706.102 Medical Electrical Equipment Part 1-2.General Requirements for Safety Collateral Standard. Electromagnetic Compatibility Requirements and Tests
3 Terms and Definitions
GB/T 10149 and the following terms and definitions apply to this document.
3.1
A scanning method using X-ray cone beam computed tomography to reconstruct three-dimensional images in axial, coronal, sagittal and
It is an X-ray imaging device that displays the normal tissue and diseased tissue structure of the oral and maxillofacial face and even the entire skull by means of three-dimensional images.
Note. This type of equipment also includes a combination of oral and maxillofacial cone beam tomography and/or oral tomography (to obtain a curved tomographic image of the oral cavity)
and/or cephalometric imaging (obtaining two-dimensional images of the frontal and lateral views of the head) and/or wrist radiography (obtaining two-dimensional images of the wrist).
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