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YY/T 1732-2020Particular specification of dental panoramic X-ray equipment (English PDF)

口腔曲面体层X射线机专用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 30, 2020

Implementation date

June 1, 2021

Scope

YY/T 1732-2020 is the English-translated version of 口腔曲面体层X射线机专用技术条件.

YY/T 1732-2020 is the Chinese pharmaceutical industry standard for the dental panoramic X-ray machine, and also for the panoramic and cephalometric parts of an oral and maxillofacial cone beam CT unit.

It gives the terms and definitions, the classification and composition, the requirements and the test methods, covering the image layer and its position, the resolution and contrast of the panoramic image, the magnification and geometric accuracy, the radiation output and the dose indices, the collimation and the protection of the operator. Issued on 30 June 2020, it has applied since 1 June 2021.

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Document preview — YY/T 1732-2020

National Standard of the People's Republic of China

Classification: C 43

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and composition
5 Requirements
5.1 Working conditions
5.2 Electric power
5.3 Loading factors and control
5.4 Imaging performance
5.5 Mechanical device performance
5.6 Software function
5.7 External interlocking device
5.8 Environmental test
5.9 Security
5.10 Electromagnetic compatibility
6 Test method
6.1 Working conditions
6.2 Electric power
6.3 Loading factors and control
6.4 Imaging performance
6.5 Mechanical device performance
6.6 Software functions
6.7 External interlocking device
6.8 Environmental test
6.9 Security
6.10 Electromagnetic compatibility
Appendix A (informative appendix) Test layout
Appendix B (informative appendix) Curved tomography test phantom
Appendix C (Informative Appendix) Supplementary Note
Appendix D (informative appendix) Panorama resolution test chart
Appendix E (informative appendix) Multifunctional test card phantom
Appendix F (Informative Appendix) Cephalometric Test Card References

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.

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) Focus.

Drafting organizations of this standard. Medical Device Inspection and Testing Institute of Liaoning Province, Medical Device Technology Review Center of National Medical Products Administration, Hefei Meiya Optoelectronics Technology Co:, Ltd:, Beijing Langshi Instrument Co:, Ltd.

1 Scope

This standard specifies the terms, definitions, classification, composition, requirements and tests of the oral curved body X-ray machine (hereinafter referred to as the panoramic machine) method.

This standard applies to panoramic cameras, and also to oral curvature tomography or cephalometric imaging of oral and maxillofacial cone-beam computed tomography equipment. Measure the photographic part.

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 document. For undated references, the latest version (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 9706.3 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 III. Parallel Standard Diagnostic X-ray Equipment Radiation Protection General requirements

GB 9706.14 Medical electrical equipment Part 2. Special requirements for the safety of X-ray equipment accessory equipment

GB 9706.15 Medical Electrical Equipment Part 1-1. General Requirements for Safety Collateral Standard. Safety Requirements for Medical Electrical Systems

GB/T 10149 Medical X-ray equipment terms and symbols

YY/T 0291 Environmental requirements and test methods for medical X-ray equipment

YY 0505 Medical Electrical Equipment Part 1-2. General Safety Requirements Collateral Standard. Electromagnetic Compatibility Requirements and Tests DICOM3.0 Digital Imaging and Communication in Medicine (DigitalImagingandCommunicationsinMedicinePS3)

3 Terms and definitions

The following terms and definitions defined in GB/T 10149 apply to this document.

3.1 Oral curved body panoramic

In dental X-ray photography, the fan-shaped X-ray beam and the X-ray image receiver jointly move around the patient's head.

The movement orientation of the middle X-ray beam is parallel to the patient's cranio-caudal axis.

Note 1. The tomographic layer obtained relative to the plane perpendicular to the axis of rotation. The resulting image is a focused projection on a surface parallel to the axis of rotation.

Note 2. The scan axis is usually vertical. [IEC 60601-2-63:2012, definition:201.3.211]

3.2 Cephalometric

Projection X-ray photography of the entire oral and maxillofacial anatomy. The projected geometry can minimize the distortion of the geometric image.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

GB 9706.3 · GB 9706.11 · GB 9706.14

Similar standards

YY/T 0010-2020|GB 9706.265-2021|GB 9706.263-2020|GB/T 26595-2011|GB/T 16544-2008|YY/T 0795-2022

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