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YY/T 1818-2022 English PDF

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YY/T 1818-2022: Dentistry - Digital impression devices
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Basic data

Standard ID YY/T 1818-2022 (YY/T1818-2022)
Description (Translated English) Dentistry - Digital impression devices
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Word Count Estimation 16,193
Issuing agency(ies) State Drug Administration

YY/T 1818-2022: Dentistry - Digital impression devices

---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.
Dentistry - Digital impression devices ICS 11.060.20 CCSC33 People's Republic of China Pharmaceutical Industry Standard Dental oral digital impression device Published on 2022-05-18 2024-06-01 Implementation Released by the State Drug Administration directory Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 2 5 Test method 3 6 Manual 4 Appendix A (normative) Preparation of Standard Models and Measurement of Acceptance Reference Values 5 Appendix B (normative) Test Method for Impression Scanning Accuracy 8 Appendix C (Informative) Impression Machine Scanning Accuracy Measurement Results Record 10 Reference 12

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. Please note that some content of this document may be patented. The issuer 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 Dental Equipment and Equipment Sub-Technical Committee of the National Standardization Technical Committee for Oral Materials and Devices (SAC/TC99 SC1) focal point. This document was drafted by. Peking University School of Stomatology, Guangdong Medical Device Quality Supervision and Inspection Institute, Taifun Medical Device Manufacturing (Part 1) Hai) Co., Ltd., Ningbo Pintai Optoelectronics Technology Co., Ltd., Dentsply Sirona Dental Products (Shanghai) Co., Ltd., Beijing Xikema Medical Branch Technology Co., Ltd. The main drafters of this document. Sun Yuchun, Zhou Yongsheng, Wang Yong, Li Weisong, Lu Wenjuan, Wu Yiming, Zhou Liangbin, Zhu Lingjian, Luo Jian, Wang Yan, Chen Lei. Dental oral digital impression device

1 Scope

This document specifies the oral digital impression instrument (hereinafter referred to as "impression instrument") that obtains 3D digital surface data directly in the patient's mouth requirements, test methods, and instructions. This document does not apply to equipment using ultrasound, radiography or magnetic resonance imaging methods.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; 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 Basic Safety and Essential Performance GB 9706.260 Medical Electrical Equipment Part 2-60.Special Requirements for Basic Safety and Basic Performance of Dental Equipment GB/T 9937 dental terminology GB/T 17163-2008 Basic terminology of geometrical measuring instruments GB/T 27418-2017 Evaluation and representation of measurement uncertainty YY/T 0628 Graphical symbols of dental equipment YY 9706.102 Medical Electrical Equipment Part 1-2.General Requirements for Basic Safety and Essential Performance Collateral Standard. Electromagnetic and capacity requirements and tests

3 Terms and Definitions

The terms and definitions defined in GB 9706.1, GB/T 9937 and GB/T 17163-2008 and the following terms and definitions apply to this document. 3.1 A combination of a hand-held scanning device used in the oral cavity and computer hardware and software, the software in which can output three-dimensional data of the scanned surface. [Source. ISO 20896-1.2019, 3.4] 3.2 digital impression digitalimpression A dataset or result obtained directly from a patient's mouth as a full-surface 3D morphological representation. NOTE. Digital impressions can contain surface color data. [Source. ISO 20896-1.2019, 3.3] 3.3 hand-heldscanningdevice A freely moving camera or similar sensor that senses light reflected or scattered from the surface of the scanned object and can convert it into A series of data corresponding to the surface morphology and orientation of the scanned object. Note 1.The device may have an independent light source.

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