Standard Number: YY/T 0771.3-2009(YY/T0771.3-2009)
Chinese:动物源医疗器械 第3部分：病毒和传播性海绵状脑病（TSE）因子去除与灭活的确认
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
Effective Date:2011-06-01
ICS:11.100.20
Standard Applicability:This part of YY/T0771 specifies requirements for the confirmation of the removal and/or inactivation of viruses and transmissible spongiform encephalopathies (TSE) factors in the manufacture of medical devices (excluding in vitro diagnostic medical devices) employing animal tissues or products derived from animal tissues that are in vivo or have been treated to be in vivo. This part applies when required by the risk management process described in YY/T0771.1. This part does not address other transmissible or non-transmissible factors. Note 1:YY/T0771.1 describes risk analysis and management. When routine sterilization processes are used for the treatment of animal tissues for medical devices, which have not been shown to be fully effective in inactivating the causative agent of transmissible spongiform encephalopathies, the selection of animal sources is extremely important (see YY/T 0771.1 and YY/T 0771.2). Note 2: Standards related to bacteria, molds and yeasts are GB 18279, GB 18280, GB/T 19973.1, YY/T 0567, ISO 14160, GB/T 19974 and ISO 17665 (see references). This part of YY/T0771 does not cover the use of human tissue in medical devices. This part of YY/T0771 does not stipulate the quality management system for the whole process control of the production of medical devices. Note 3: The operation of a comprehensive quality management system in the production process is not a requirement of this part, but this part specifies the requirements for certain elements of the quality management system. To note that the control of medical equipment production or reprocessing of all stages of quality management system standards (see YY/T0287), this part of the quality management system elements can be used as part of the quality management system in line with the requirements of YY/T0287 This part of YY/T0771 does not examine the effect of any removal and/or inactivation method on the suitability of the medical device for its intended use.
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