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General requirements of performance evaluation of in vitro diagnostic medical devices
Basic information
Standard No：YY/T 1441-2016
Standard Name：体外诊断医疗器械性能评估通用要求
English Name：General requirements of performance evaluation of in vitro diagnostic medical devices
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：11.100
CCS Number：C30
Related Standards
Referenced Standards：GB/T 19001-2008,YY/T 0287-2003
Publication Information
Number of pages：12
Number of words：14 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2017-02-01
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：1441
Drafter：赵阳、张宏、刘向祎、于婷、陶源、屈媛媛
Drafting Organization：北京市医疗器械检验所、北京市医疗器械技术审评中心、北京同仁医院、中国食品药品检定研究院医疗器械检定所、罗氏诊断产品(上海)有限公司
Management Organization：全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
Proposing Department：国家食品药品监督管理总局
