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Biological evaluation of medical devices used in dentistry-Part 18:Dentine barrier cytotoxicity test
Standard in brief
Scope of Application:
YY/T 0127的本部分规定了口腔材料牙本质屏障细胞毒性试验方法。
本部分适用于评价牙体充填材料和牙齿窝洞治疗的相关材料及其可滤沥成分经牙本质屏障后对细胞毒性的影响。
Basic information
Standard No:YY/T 0127.18-2016
Standard Name:口腔医疗器械生物学评价 第18部分:牙本质屏障细胞毒性试验
English Name:Biological evaluation of medical devices used in dentistry-Part 18:Dentine barrier cytotoxicity test
Standard Status:现行
Release Date:2016-01-26
Effective Date:2017-01-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.060.10
CCS Number:C33
Related Standards
Referenced Standards:GB/T 16886.5,GB/T 16886.12,ISO 7405-AMD:2013
Publication Information
Number of pages:16
Number of words:26 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2017-01-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家食品药品监督管理总局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:0127.18
Drafter:林红、蒋若丹、郑刚
Drafting Organization:国家食品药品监督管理总局北大医疗器械质量监督检验中心
Management Organization:全国口腔材料和器械设备标准化技术委员会(SAC/TC 99)
Proposing Department:国家食品药品监督管理总局