YY/T 0771.3-2009 English PDF

US$454.00 · In stock
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YY/T 0771.3-2009: Medical devices utilizing animal tissues and their derivatives. Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0771.3-2009	454	Add to Cart	4 days	Medical devices utilizing animal tissues and their derivatives. Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents	Valid

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YY/T 0841   YY/T 0664   YY 0709   YY/T 0870.8   YY/T 0771.1   YY/T 0771.2   

Basic data

Standard ID: YY/T 0771.3-2009 (YY/T0771.3-2009)
Description (Translated English): Medical devices utilizing animal tissues and their derivatives. Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.100.20
Word Count Estimation: 23,249
Date of Issue: 2009-12-30
Date of Implementation: 2011-06-01
Quoted Standard: YY/T 0771.1; YY/T 0771.2
Adopted Standard: ISO 22442-3-2007, IDT
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the use of animal tissues or products derived from animal tissue medical equipment (not including in vitro diagnostic medical devices) in the production of the virus and transmissible spongiform encephalopathy (TSE) factor removal and/or inactivation requirements for confirmation these animal tissues or products derived from animal tissue is non- viable or treated as non- viable. In this section YY/T 0771. 1 The risk management process need apply. This section does not involve the transmission or non- transmission of other factors. YY/T 0771 does not consider this part of any removal and/or inactivation methods used for medical devices is expected to influence the suitability.

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