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YY/T 1732-2020 English PDF

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YY/T 1732-2020: (Special technical conditions for oral curved body X-ray machine)
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Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1732-2020	English	499	Add to Cart	6 days [Need to translate]	(Special technical conditions for oral curved body X-ray machine)	Valid	YY/T 1732-2020

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Basic data

Standard ID	YY/T 1732-2020 (YY/T1732-2020)
Description (Translated English)	(Special technical conditions for oral curved body X-ray machine)
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C43
Word Count Estimation	27,256
Date of Issue	2020-06-30
Date of Implementation	2021-06-01
Regulation (derived from)	Announcement No. 76 (2020) of the National Medical Products Administration
Issuing agency(ies)	State Drug Administration

YY/T 1732-2020: (Special technical conditions for oral curved body X-ray machine)

---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.
(Special technical conditions for oral curved body X-ray machine) ICS 11:040:50 C43 People's Republic of China Pharmaceutical Industry Standard Special technical conditions for oral curved body X-ray machine 2020-06-30 released 2021-06-01 implementation Issued by the State Drug Administration

Preface Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Classification and composition 2 5 Requirements 2 5:1 Working conditions 2 5:2 Electric power 3 5:3 Loading factors and control 3 5:4 Imaging performance 4 5:5 Mechanical device performance 5 5:6 Software function 5 5:7 External interlocking device 6 5:8 Environmental test 6 5:9 Security 6 5:10 Electromagnetic compatibility 6 6 Test method 6 6:1 Working conditions 6 6:2 Electric power 6 6:3 Loading factors and control 6 6:4 Imaging performance 7 6:5 Mechanical device performance 11 6:6 Software functions 11 6:7 External interlocking device 11 6:8 Environmental test 11 6:9 Security 11 6:10 Electromagnetic compatibility 11 Appendix A (informative appendix) Test layout 12 Appendix B (informative appendix) Curved tomography test phantom 14 Appendix C (Informative Appendix) Supplementary Note 17 Appendix D (informative appendix) Panorama resolution test chart 19 Appendix E (informative appendix) Multifunctional test card phantom 20 Appendix F (Informative Appendix) Cephalometric Test Card 22 References 24

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: The main drafters of this standard: Sun Zhiyong, Zhang Longda, Zhang Qing, Qu Hongyan, Wu Hongxin: Special technical conditions for oral curved body X-ray machine

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 article Pieces: 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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