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

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Scope

This Part of YY/T 0771 specifies requirements for the validation of the elimination and/or
inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents during the
manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal
tissues or derivatives thereof that are rendered non-viable or non-viable through processing.
This Part applies when required by the risk management process described in YY/T 0771.1.
This Part does not address other transmissible or non-transmissible agents.
NOTE 1: YY/T 0771.1 describes risk analysis and management. Since conventional sterilization
processes used for animal tissues in medical devices have not been shown to be fully effective in
inactivating TSE agents, the selection of animal sources is of critical importance (see YY/T 0771.1 and
YY/T 0771.2).
NOTE 2: Standards relating to bacteria, molds, and yeasts include GB 18279, GB 18280, GB/T 19973.1,
YY/T 0567, ISO 14160, GB/T 19974, and ISO 17665 (see Bibliography).
This Part of YY/T 0771 does not cover the use of human tissues in medical devices.
This Part of YY/T 0771 does not specify a quality management system for the control of the
entire medical device manufacturing process.
NOTE 3: Implementation of a comprehensive quality management system during production is not a
requirement of this Part; however, this Part specifies requirements for certain elements of a quality
management system. Attention shall be paid to quality management system standards (see YY/T 0287)
governing all stages of medical device manufacture or reprocessing. The quality management system
elements specified in this Part may serve as part of a quality management system that complies with
YY/T 0287.
This Part of YY/T 0771 does not consider the impact of any elimination and/or inactivation
methods on the suitability of the medical device for its intended use.

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 and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100.20
Word Count Estimation	23,275
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.