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Test for genotoxicity of medical devices—Part 4:Mammalian bone marrow erythocyte micronucleus test
Standard in brief
Scope of Application:
YY/T 0870的本部分规定了医疗器械/材料诱导哺乳动物骨髓红细胞微核形成试验方法。
注:口腔材料的哺乳动物红细胞微核试验见YY/T 0127.12。
Basic information
Standard No:YY/T 0870.4-2014
Standard Name:医疗器械遗传毒性试验 第4部分:哺乳动物骨髓红细胞微核试验
English Name:Test for genotoxicity of medical devices—Part 4:Mammalian bone marrow erythocyte micronucleus test
Standard Status:现行
Release Date:2014-06-17
Effective Date:2015-07-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.01
CCS Number:C30
Related Standards
Referenced Standards:GB/T 16886.1,GB/T 16886.2,GB/T 16886.3,GB/T 16886.12,YY/T 0870.2-2013
Publication Information
Number of pages:8
Number of words:8 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2014-12-01
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:0870.4
Drafter:侯丽、王昕、刘成虎、袁暾、林红、韩建民
Drafting Organization:国家食品药品监督管理局济南医疗器械质量监督检验中心
Management Organization:全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)
Proposing Department:国家食品药品监督管理总局