**器械FDA注冊(cè)關(guān)于模擬運(yùn)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(méi)有進(jìn)行模擬運(yùn)輸測(cè)試，然后再進(jìn)行適當(dāng)?shù)陌b完整性測(cè)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(cè)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(yùn)輸試驗(yàn)前設(shè)置環(huán)境條件，應(yīng)將測(cè)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(qǐng)注意，包裝完整性測(cè)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(jì)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(jìn)行特定的性能測(cè)試，以確定嚴(yán)酷的運(yùn)輸和發(fā)運(yùn)方式是否會(huì)影響產(chǎn)品性能。