**器械FDA注册关于模拟运输建议

**器械FDA注册关于模拟运输建议

 If you have not conducted simulated shipping distribution testing followed by appropriate packaging integrity testing, we have the following general recommendations. 如果您还没有进行模拟运输测试，然后再进行适当的包装完整性测试，则我们有以下一般建议。

 Please be aware that the testing should be conducted on final, finished devices. 测试样品为**终灭菌后的样品

For environmental conditioning prior to simulated shipping distribution, test samples should be exposed to different anticipated environmental conditions of cold, hot, and humidity that your device might be exposed to. 为了在模拟运输试验前设置环境条件，应将测试样品暴露于该产品可能暴露的不同预期冷，热和潮湿环境条件下。

Please be aware that the number of samples used in package integrity testing should be large enough to provide for statistically significant analysis with a high degree of reliability; for example, 95% confidence at 95% reliability or greater. 请注意，包装完整性测试中使用的样品数量应足够大，以提供具有高度可靠性的统计显着性分析； 例如，在95％或更高的可靠性下具有95％的置信度。

In addition, device specific performance testing as appropriate should be conducted to determine whether the rigors of shipping and distribution may affect the performance of your device. 此外，应进行特定的性能测试，以确定严酷的运输和发运方式是否会影响产品性能。