YY/T 0771.4-2015/ISO/TR 22442-4 :2010.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.
为帮助确定无活力动物组织来源的医疗器械的加工过程是否有助于减少传播性海绵状脑病(TSEs)的医源性传播的风险,本部分为设计和开展确认分析提供建议。加工动物组...................
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