Standard No.:	YY/T 0771.4-2015
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
Chinese 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
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.100.20 11.100.20    Biological evaluation of medical devices 11.100.20
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2015-03-02
Implemented on:	2016-1-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	8500 words
Translation Price(USD):	250.0
Delivery:	via email in 1~3 business day

本标准规定了动物源医疗器械中传播性海绵状脑病（TSE）因子的去除和/或灭活及其过程确认分析的原则。
本标准适用于对无活力动物组织来源的医疗器械加工过程是否有助于减少传播性海绵状脑病（TSE）的医源性传播风险的确认。