YY/T 1818-2022 Active Industry standards-Medicine

YY/T 1818-2022 Dentistry—Digital impression devices

Publish Date: 2022-05-18 Implement Date: 2024-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1818-2022

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Dental instruments, equipment, and materials

ICS Name: Dental equipment

Publish Date: 2022-05-18

Implement Date: 2024-06-01

Publisher: 国家药品监督管理局

Technical Committee: 全国口腔材料和器械设备标准化技术委员会齿科设备与器械分技术委员会(SAC/TC 99 SC 1)

Pages: 20 pages

Scope

本文件规定了直接在患者口腔内获取三维数字化表面数据的口腔数字印模仪（以下简称“印模仪”)的要求、试验方法、说明书。本文件不适用于使用超声、射线或磁共振成像方法的设备。

Development Information

Drafting Units:

北京大学口腔医学院、广东省医疗器械质量监督检验所、泰夫恩医疗器械制造(上海)有限公司、宁波频泰光电科技有限公司、登士柏西诺德牙科产品(上海)有限公司、北京西科码医疗科技股份有限公司

Drafting Persons:

孙玉春、周永胜、王勇、李伟松、卢文娟、伍倚明、周良彬、朱凌剑、罗剑、王燕、陈雷

Word Count: 31 Thousand words Pages: 20 pages

Referenced Standards

GB/T 17163-2008 Glossary of terms used in dimensional measuring instruments—General terms GB/T 27418-2017 Guide to the evaluation and expression of uncertainty in measurement GB 7247.1-2001 Safety of laser products—Part 1:Equipment classification, requirements and user's guide GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.260-2020 Medical electrical equipment—Part 2-60:Particular requirements for the basic safety and essential performance of dental equipment GB/T 9937-1988 Terms associated with the testing and the operating of dental material, instruments and equipment GB/T 9937-2020 Dentistry—Vocabulary GB/T 9937.1-2008 Dental vocabulary—Part 1:General and clinical terms GB/T 9937.2-2008 Dental vocabulary—Part 2:Dental materials GB/T 9937.3-2008 Dental vocabulary—Part 3:Dental instruments GB/T 9937.4-2005 Dental vocabulary—Part 4:Dental equipment GB/T 9937.5-2008 Dental vocabulary—Part 5:Terms associated with testing YY/T 0628-2008 Dental equipment—Graphical symbols YY/T 0628-2020 Dentistry—Graphical symbols for dental equipment YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests GB/T 7247.1-2024 Safety of laser products—Part1:Equipment classification and requirements

Related Standards

GB 8666.1-1988 Abolished

GB 8666.1-1988 General specifications for tooth forceps

Publish Date: 1988-02-13

YY 0460-2003 Replaced

YY 0460-2003 Ultrasonics dental descaler equipment

Publish Date: 2003-06-20

GB 19342-2003 Replaced

GB 19342-2003 Tooth Brush

Publish Date: 2003-10-09

YY/T 0058-2004 Replaced

YY/T 0058-2004 Dental patient chair

Publish Date: 2004-10-10

YY/T 1012-2004 Replaced

YY/T 1012-2004 Dental handpieces—Coupling dimensions

Publish Date: 2004-10-10

YY/T 1043-2004 Replaced

YY/T 1043-2004 Dental units

Publish Date: 2004-10-10