GB/T 6387-1986
Replaced
YY/T 1886-2023
Active
Industry standards-Medicine
YY/T 1886-2023 Dentistry—Pre-capsulated dental amalgam
YY/T 1886-2023 Dentistry—Pre-capsulated dental amalgam
Basic Information
Standard Code:
YY/T 1886-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Dental instruments, equipment, and materials
ICS Name:
Dental materials
Publish Date:
2023-01-13
Implement Date:
2024-01-15
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(SAC/TC 99)
Pages:
32 pages
Scope
本文件规定了胶囊装银汞合金产品的性能要求和测试方法,该产品中一定比例的牙科银合金粉和牙科汞的装量适于制作单个牙齿充填体;规定了用于制备牙科银汞合金的牙科银合金粉和胶囊以及银汞合金的性能要求和试验方法,同时规定了对包装和标识的要求。
本文件适用于标有“预装胶囊”的牙科银汞合金产品。
本文件不适用于散装形式的可自由流动的银合金粉和片剂银合金粉,也不适用于汞包和散装汞。本文件不适用于利用金属合金粉末和液体合金在环境温度下反应生成固态金属材料的用于制作牙科修复体的金属材料。
本文件不包含对可能的生物学危害的定性和定量的要求,但推荐在评价可能的生物学危害时,参考GB/T 16886.1和YY/T 0268。
Development Information
Drafting Units:
北京大学口腔医学院口腔医疗器械检验中心、上海医疗器械股份有限公司齿科材料厂
Drafting Persons:
袁慎坡、林红、孙志辉、杜祖敏、白伟、张殿云
Referenced Standards
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
ISO 7488
GB/T 1800.2-1998 Limits and fits—Bases—Part 2:Basic rules of tolerances, deviations and fits
GB/T 1800.2-2009 Geometrical Product Specifications (GPS)—Limits and fits—Part 2:Tables of standard tolerance grades and limit deviations for holes and shafts
GB/T 1800.2-2020 Geometrical product specifications(GPS)—ISO code system for tolerances on linear sizes—Part 2:Tables of standard tolerance classes and limit deviations for holes and shafts
GB/T 2893.2-2008 Graphical symbols—Safety colours and safety signs—Part 2:Design principles for product safety labels
GB/T 2893.2-2020 Graphical symbols—Safety colours and safety signs—Part 2:Design principles for product safety labels
GB/T 6003.1-1997 Test sieves of metal wire cloth
GB/T 6003.1-2012 Test sieves—Technical requirements and testing—Part 1:Test sieves of metal wire cloth
GB/T 6003.1-2022 Test sieves—Technical requirements and testing—Part 1:Test sieves of metal wire cloth
GB/T 9258.1-2000 Coated abrasives—Grain size analysis—Part 1:Grain size distribution test
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 18778.2-2003 Geometrical product specifications(GPS)—Surface texture:Profile method—Surface having stratified functional properties—Part 2:Height characterization using the linear material ratio curve
Adopt standards
ISO 20749:2017
Related Standards
YY 0270-2003
Replaced
YY 0270-2003 Dentistry—Denture base polymers
YY 0462-2003
Replaced
YY 0462-2003 Dental gypsum products
YY 0463-2003
Replaced
YY 0463-2003 Dental phosphate-bonded casting investments
YY 1042-2003
Replaced
YY 1042-2003 Dentistry—Polymer-based filling,restorative and luting materials
YY 0493-2004
Replaced