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Biological evaluation of medical devices used in dentistry—Part 2:Test method—Salmonella typhimurium reverse mutation assay(Ames mutagenicity test)
Standard in brief
Scope of Application：
YY/T 0127的本部分规定了口腔医疗器械鼠伤寒沙门氏杆菌回复突变试验方法。本试验用于测定可引起沙门氏杆菌基因置换和／或移码突变的口腔材料所诱发的依赖于组氨酸(his-)的菌株产生不依赖于组氨酸(his+)的基因突变。为检测口腔医疗器械的诱变性试验之一。
Basic information
Standard No：YY/T 0127.10-2009
Standard Name：口腔医疗器械生物学评价 第2单元：试验方法 鼠伤寒沙门氏杆菌回复突变试验(Ames试验)
English Name：Biological evaluation of medical devices used in dentistry—Part 2:Test method—Salmonella typhimurium reverse mutation assay(Ames mutagenicity test)
Standard Status：现行
Release Date：2001-01-01
Effective Date：2010-12-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.060.10
CCS Number：C33
Related Standards
Referenced Standards：GB 7919-1987,GB 15193.4-2003,GB/T 16886.12
Publication Information
Number of pages：12
Number of words：16 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2009-12-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家食品药品监督管理局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：0127.10
Drafter：林红、李盛林、付嘉、王衣祥、郝鹏
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
Management Organization：全国口腔材料和器械设备标准化技术委员会
Proposing Department：国家食品药品监督管理局
