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  • 匿名
关注:1 2013-05-23 12:21

求翻译:For products incorporating non-viable human tissues, cells and substances falling within the definition of a medical device, the selection of sources, donors and/or substances of human origin, the processing, preservation, testing and handling of tissues, cells and substances of such origin should be carried out so as to provide optimal safety. In particular, safety with regard to viruses and other transmissible agents should be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.是什么意思?

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For products incorporating non-viable human tissues, cells and substances falling within the definition of a medical device, the selection of sources, donors and/or substances of human origin, the processing, preservation, testing and handling of tissues, cells and substances of such origin should be carried out so as to provide optimal safety. In particular, safety with regard to viruses and other transmissible agents should be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.
问题补充:

  • 匿名
2013-05-23 12:26:38
产品纳入非可行的人体组织、 细胞和物质范围内定义的医疗设备,选用来源、 捐助者和/或物质的人类起源、 处理、 保存、 测试及处理组织、 细胞和物质的这种起源应进行,提供最佳的安全。特别是,病毒和其他传染性的代理方面的安全应由消除或失活在制造过程中的验证方法的实现。
 
 
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