ISO13485-2016中英文對(duì)照 產(chǎn)品實(shí)現(xiàn)（7.5.10~7.5.11）

7.5.10 Customer property 顧客財(cái)產(chǎn)

The organizationshall identify, verify, protect, and safeguard customer property provided foruse or incorporation into the product while it is under the organization’scontrol or being used by the organization. If any customer property is lost,damaged or otherwise found to be unsuitable for use, the organization shallreport this to the customer and maintain records (see 4.2.5).

當(dāng)產(chǎn)品在組織的控制下或準(zhǔn)備在組織中使用時(shí)，組織應(yīng)當(dāng)確定、核實(shí)、保護(hù)和保衛(wèi)供其使用或構(gòu)成產(chǎn)品一部分的顧客財(cái)產(chǎn)。如果任何顧客財(cái)產(chǎn)損失、毀壞或發(fā)現(xiàn)不適用情況時(shí)，組織應(yīng)當(dāng)向客戶進(jìn)行告知并保留相關(guān)記錄（見4.2.5）。

刪減YY/T0287備注項(xiàng)。

7.5.11 Preservation of product 產(chǎn)品防護(hù)

The organization shalldocument procedures for preserving the conformity of product to requirements duringprocessing, storage, handling, and distribution. Preservation shall apply tothe constituent parts of a medical device.

組織應(yīng)當(dāng)建立防護(hù)程序用以在制造、存儲(chǔ)、處理和銷售過程中防護(hù)產(chǎn)品從而符合產(chǎn)品防護(hù)方面的要求，防護(hù)也應(yīng)適用于產(chǎn)品的組成部分。

The organization shall protectproduct from alteration, contamination or damage when exposed to expectedconditions and hazards during processing, storage, handling, and distributionby:

當(dāng)產(chǎn)品處于在預(yù)期的條件下以及處于生產(chǎn)過程、存儲(chǔ)、處理和銷售的危害下時(shí)，組織應(yīng)當(dāng)通過以此措施保護(hù)產(chǎn)品遠(yuǎn)離變化、污染、損害：

a) designing and constructingsuitable packaging and shipping containers;

設(shè)計(jì)和制造合適包裝和運(yùn)輸容器；

b) documenting requirements forspecial conditions needed if packaging alone cannot provide preservation.

如果僅靠包裝不能提供保護(hù)時(shí)，針對(duì)專有的必須的條件形成文件化的要求。

If special conditions are required,they shall be controlled and recorded (see 4.2.5).

如果確實(shí)需要特殊情況，這些情況應(yīng)當(dāng)予以控制和記錄（見4.2.5）

本部分內(nèi)容描述與YY/T0287有很多不同。

總結(jié)：本部分內(nèi)容與YY/T0287最大的不同是文件格式排序不一樣。其次三個(gè)部分文件內(nèi)容增加最多，變化最大。7.5.4、7.5.7和7.5.11。