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Database: 189760 (25 Oct 2025)
YY/T 0771.3-2009 English PDF
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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
Contents [version]
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Standard Title (Description)
Status
PDF
YY/T 0771.3-2009
English
454
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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
YY/T 0771.3-2009
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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.