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Medical devices utilizing animal tissues and their derivatives—Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes
Basic information
Standard No：YY/T 0771.4-2015
Standard Name：动物源医疗器械 第4部分：传播性海绵状脑病(TSE)因子的去除和/或灭活及其过程确认分析的原则
English Name：Medical devices utilizing animal tissues and their derivatives—Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes
Standard Status：现行
Release Date：2015-03-02
Effective Date：2016-01-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.100.20
CCS Number：C30
Related Standards
Referenced Standards：ISO 14160,ISO 22442-1,ISO 22442-2,ISO 22442-3
Adopted Standards：ISO/TR 22442-4:2010
Adopted Standard Name：《动物源医疗器械 第4部分：传播性海绵状脑病(TSE)因子的去除和/或灭活及其过程确认分析的原则》
Adoption Level：IDT
Publication Information
Number of pages：20
Number of words：30 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2015-06-01
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：0771.4
Drafter：刘成虎、由少华、吴平
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
