**器械FDA注冊關(guān)于模擬運輸建議

 If you have not conducted simulated shipping distribution testing followed by appropriate packaging integrity testing, we have the following general recommendations. 如果您還沒有進行模擬運輸測試，然后再進行適當?shù)陌b完整性測試，則我們有以下一般建議。

 Please be aware that the testing should be conducted on final, finished devices. 測試樣品為**終滅菌后的樣品

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. 為了在模擬運輸試驗前設(shè)置環(huán)境條件，應(yīng)將測試樣品暴露于該產(chǎn)品可能暴露的不同預(yù)期冷，熱和潮濕環(huán)境條件下。

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. 請注意，包裝完整性測試中使用的樣品數(shù)量應(yīng)足夠大，以提供具有高度可靠性的統(tǒng)計顯著性分析； 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，應(yīng)進行特定的性能測試，以確定嚴酷的運輸和發(fā)運方式是否會影響產(chǎn)品性能。