YY 1045.1-2009
Replaced
YY 1045-2021
Active
Industry standards-Medicine
YY 1045-2021 Dentistry—Handpieces and motors
YY 1045-2021 Dentistry—Handpieces and motors
Basic Information
Standard Code:
YY 1045-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Dental instruments, equipment, and materials
ICS Name:
Dental instruments
Publish Date:
2021-09-06
Implement Date:
2024-05-01
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:
40 pages
Scope
本文件规定了用于治疗牙科患者并与患者接触的各种结构的手机和马达的要求、试验方法,也规定了制造商信息、标志的要求。
本文件适用于:
a)直手机和弯手机;
b)高速气涡轮手机;
c)气动马达;
d)电动马达;
e)抛光手机。
本文件不适用于:
——口腔摄像手机;
——光固化手机;
——气动洁牙机;
——电动洁牙机;
——喷砂手机;
——多功能喷枪。
注: 附录A阐明了本文件所涵盖的手机和马达的类型。
Development Information
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
YY/T 0913-2015 Dentistry—Mandrels for rotary instruments
GB/T 1184-1996 Geometrical tolerancing—Geometrical tolerance for features without individual tolerance indications
GB/T 1804-2000 General tolerances for linear and angular dimensions without individual tolerance indications
GB/T 3785.1-2010 Electroacoustics—Sound level meters—Part 1:Specifications
GB/T 3785.1-2023 Electroacoustics—Sound level meters—Part 1:Specifications
GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method
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 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
YY/T 0514-2018 Dentistry—Hose connectors for air driven dental handpieces
YY/T 0628-2008 Dental equipment—Graphical symbols
YY/T 0628-2020 Dentistry—Graphical symbols for dental equipment
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 0967-2022 Dentistry—Shanks for rotary and oscillating instruments
YY/T 0967.1-2015 Dental rotary instruments—Shanks—Part 1:Shanks made of metals
YY/T 0967.2-2015 Dental rotary instruments—Shanks—Part2:Shanks made of plastics
YY/T 0967.3-2016 Dental rotary instruments—Shanks—Part 3:Shanks made of ceramics
YY/T 1012-2004 Dental handpieces—Coupling dimensions
YY/T 1012-2021 Dentistry—Coupling dimensions for handpiece connectors
YY/T 1043.1-2016 Dentistry—Dental units—Part 1:General requirements and test methods
YY/T 1043.1-2022 Dentistry—Stationary dental units and dental patient chairs—Part 1:General requirements
YY/T 1501-2016 Dentistry—Graphical symbols for dental instruments
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
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 14457:2017
Related Standards
YY 1045.2-2010
Replaced
YY 1045.2-2010 Dental handpieces—Part 2:Straight and geared angle handpieces
YY/T 0805.3-2010
Active
YY/T 0805.3-2010 Dentistry—Diamond rotary instrument—Part 3:Grit size designation and color code
YY/T 0873.1-2013
Active
YY/T 0873.1-2013 Dentistry—Number coding system for rotary instruments—Part 1:General characteristics
YY/T 0805.2-2014
Active
YY/T 0805.2-2014 Dentistry—diamond rotary instrument—Part 2:Discs
YY/T 0873.2-2014
Active