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  • 匿名
关注:1 2013-05-23 12:21

求翻译:Products incorporating non-viable tissues, cells and substances of animal origin falling within the definition of a medical device, should originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues. The product owner is required to retain information on the geographical origin of the animals. Processing, preservation, testing and handling of tissues, cells and substances of animal 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?

待解决 悬赏分:1 - 离问题结束还有
Products incorporating non-viable tissues, cells and substances of animal origin falling within the definition of a medical device, should originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues. The product owner is required to retain information on the geographical origin of the animals. Processing, preservation, testing and handling of tissues, cells and substances of animal 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
非可行的组织、 细胞和物质的范围内的医疗设备,定义的动物源性产品应来自受到兽医控制和监测适应组织的用途的动物。产品所有者是保留的动物地理来源信息所需的。加工、 保鲜、 测试及处理的组织,细胞和动物性药物应进行,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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