YY/T 1043.1-2022 Active Industry standards-Medicine

YY/T 1043.1-2022 Dentistry—Stationary dental units and dental patient chairs—Part 1:General requirements

YY/T 1043.1-2022 Dentistry—Stationary dental units and dental patient chairs—Part 1:General requirements

Publish Date: 2022-10-17 Implement Date: 2024-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1043.1-2022
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Dental instruments, equipment, and materials
ICS Name: Dental equipment
Publish Date: 2022-10-17
Implement Date: 2024-04-01
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: 16 pages

Scope

本文件规定了非移动的牙科治疗机、牙科病人椅以及两者组合的要求和测试方法,不论它们是否是电动的。
本文件还规定了使用说明书、技术说明书、标记和包装的要求。
本文件不适用于医师椅、可携带的牙科设备和口腔灯。

Development Information

Drafting Units:

广东省医疗器械质量监督检验所、西诺医疗器械集团有限公司、广东福肯科技工业有限公司、佛山市盛田医疗器械有限公司、宁波蓝野医疗器械有限公司

Drafting Persons:

伍倚明、刘思胜、张晓康、李伟松、赵丽君、雷康宁、毛献辉、徐依

Word Count: 26 Thousand words Pages: 16 pages

Replace the following standards

Referenced Standards

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 17927.1-2011 Upholstered furniture—Assessment of the resistance to ignition of mattress and sofa—Part 1:Smouldering cigarette 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 GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process YY/T 0514-2018 Dentistry—Hose connectors for air driven dental handpieces YY/T 0802-2010 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer YY/T 0835-2011 Dentistry—Amalgam separators YY/T 0841-2011 Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment YY/T 0841-2023 Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment YY/T 1043.2-2018 Dentistry—Dental units—Part 2:Air,water,suction and wastewater systems YY/T 1285-2015 Dentistry—Information system on the location of dental equipment in the working area of the oral health care provider YY/T 1400-2016 Dentistry—Materials used for dental equipment surfaces—Determination of resistance to chemical disinfectants YY/T 1474-2016 Medical devices—Application of usability engineering to medical devices YY/T 0802.1-2024 Processing of medical devive—Information to be provided by the medical device manufacturer—Part 1:Critical and semi-critical medical devices YY/T 0802.2-2024 Processing of medical device—Information to be provided by the medical device manufacturer—Part 2:Non-critical medical devices

Adopt standards

ISO 7494-1:2018

Related Standards

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