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关注:1
2013-05-23 12:21
求翻译:When designing a home use device, you should account for the range of environments in which it might be used and the applicable environmental conditions noted below. These conditions should be addressed with all devices that will be used in a home or non-clinical setting. The labeling of the device should include warni是什么意思? 待解决
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When designing a home use device, you should account for the range of environments in which it might be used and the applicable environmental conditions noted below. These conditions should be addressed with all devices that will be used in a home or non-clinical setting. The labeling of the device should include warni
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2013-05-23 12:21:38
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2013-05-23 12:23:18
在设计主页使用设备 , 您应该考虑的范围广泛的环境中 , 它可能会使用和适用的环境条件如下。 这些条件应与所有的设备将被用于家庭或非临床的设置。
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2013-05-23 12:24:58
当设计一个家庭用途设备时,您应该占也许下面使用它,并且可适用的环境状况被注意环境的范围。 These conditions should be addressed with all devices that will be used in a home or non-clinical setting. The labeling of the device should include warnings against using the device in environmental conditions that would raise safety or effectiveness con
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2013-05-23 12:26:38
当家用装置的设计,你应该考虑范围的环境中,它可能使用和下文所述的适用的环境条件。这些条件应处理将家庭或非临床的设置中使用的所有设备。贴标设备应包括警告反对使用该设备在环境条件下,将提高安全或成效方面的顾虑;然而,通过设备设计管理风险管理风险通过标签要好。FDA 建议,在您为您的设备设计的上市前提交,你包括你带去要考虑到以下的特点,努力总结如果他们属于您的设备的预期的使用环境。如果某些项不相关的你正在设计的设备的类型,然后你不会考虑他们在您的设备设计。
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2013-05-23 12:28:18
正在翻译,请等待...
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