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Biological evaluation of medical devices used in dentistry—Part 15:Subacute and subchronic systemic toxicity test:oral route
Standard in brief
Scope of Application：
YY/T 0127的本部分规定了口腔医疗器械亚急性和亚慢性经口全身毒性试验方法。本部分适用于评价与口腔接触的医疗器械经口途径的亚急性和亚慢性全身毒性。
Basic information
Standard No：YY/T 0127.15-2018
Standard Name：口腔医疗器械生物学评价 第15部分：亚急性和亚慢性全身毒性试验：经口途径
English Name：Biological evaluation of medical devices used in dentistry—Part 15:Subacute and subchronic systemic toxicity test:oral route
Standard Status：现行
Release Date：2009-01-01
Effective Date：2019-05-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.060.10
CCS Number：C33
Related Standards
Referenced Standards：ISO 10993-11,ISO 10993-12
Publication Information
Number of pages：20
Number of words：26 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2018-06-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家药品监督管理局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：0127.15
Drafter：林红、韩建民、李盛林、葛兮源、傅嘉、梁洁、袁暾、孙皎、黄皙伟、陆华
Drafting Organization：国家药品监督管理局北大医疗器械质量监督检验中心、四川医疗器械生物材料和制品检验中心、上海生物材料研究测试中心
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：国家药品监督管理局
