Standard No.:	YY/T 0771.4-2015
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
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
Professional Classification:	C30 Medical apparatus and devices in general
Professional Classification:	YY Professional Standard - Pharmaceutics
Issued by:
Issued on:	2015-03-02
Implemented on:	2016-01-01
Status:	VALID
Language:	English
File Format:	PDF
Word Count:	10000 words
Price(USD):	(USD)
Delivery:	via email in 1-3 business day

下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
ISO14160 含动物源材料的一次性使用医疗器械的灭菌 液体化学灭菌剂灭菌的确认与常规控制(Sterilizationofsingle-usemedicaldevicesincorporatingmaterialsofanimalorigin—Validationand routinecontrolofsterilizationbyliquidchemicalsterilants)
ISO22442-1 动物源医疗器械 第1部分:风险管理应用(Medicaldevicesutilizinganimaltissues
andtheirderivatives—Part1:Applicationofriskmanagement)
ISO22442-2 动物源医疗器械 第2部分:来源、收集与处置的控制(Medicaldevicesutilizinganimaltissuesandtheirderivatives—
Part2:Controlsonsourcing,collectionandhandling)
ISO22442-3 动物源医疗器械 第3部分:病毒和传播性海绵状脑病(TSE)因子去除和/或灭活的确认(Medicaldevicesutilizinganimaltissuesandtheirderivatives—Part3:Validationoftheeliminationand/