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Biological evaluation of medical devices used in dentistry—Part 3:Endodontic usage test
Standard in brief
Scope of Application:
YY/T 0127的本部分规定了口腔材料根管内应用试验方法。该试验方法用于评价根尖区牙髓断端组织及根尖周组织对根管内材料的生物相容性。也包括材料在临床应用中所必需的一些操作过程的评价。
Basic information
Standard No:YY/T 0127.3-2014
Standard Name:口腔医疗器械生物学评价 第3部分:根管内应用试验
English Name:Biological evaluation of medical devices used in dentistry—Part 3:Endodontic usage test
Standard Status:现行
Release Date:1998-04-08
Effective Date:2015-07-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.060.10
CCS Number:C33
Related Standards
Referenced Standards:GB/T 16886.2
Adopted Standards:ISO 7405:2008
Adopted Standard Name:《牙科学 用于口腔的医疗器械生物相容性评价》
Adoption Level:MOD
Publication Information
Number of pages:12
Number of words:12 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2014-10-01
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:0127.3
Drafter:林红、韩建民、岳林
Drafting Organization:国家食品药品监督管理局北大医疗器械质量监督检验中心、北京大学口腔医学院
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