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YY/T 1818-2022Dentistry-Digital impression devices (English PDF)

牙科学口腔数字印模仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 18, 2022

Implementation date

June 1, 2024

Scope

YY/T 1818-2022 is the English-translated version of 牙科学口腔数字印模仪.

YY/T 1818-2022 is the Chinese pharmaceutical industry standard for the dental digital impression device, the intraoral scanner that captures the three-dimensional surface of the teeth directly in the patient's mouth instead of taking a physical impression.

It sets the requirements and the test methods for the device and states what the instructions must contain, covering the trueness and precision of the captured surface, the scanning field and the way separate scans are stitched, the resolution and colour rendition where the device has it, the data formats it produces and the cleaning and sterilization of the part that enters the mouth.

It does not apply to devices that work by ultrasound, radiography or magnetic resonance. Issued on 18 May 2022, it has applied since 1 June 2024.

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Document preview — YY/T 1818-2022

National Standard of the People's Republic of China

Classification: C 33

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

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Requirements
5 Test method
6 Manual
Appendix A (normative) Preparation of Standard Models and Measurement of Acceptance Reference Values
Appendix B (normative) Test Method for Impression Scanning Accuracy
Appendix C (Informative) Impression Machine Scanning Accuracy Measurement Results Record
Reference

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.

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 Digital impression device

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

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 0493-2022

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