7.5.7 Particular requirements for validation ofprocesses for sterilization and sterile
barrier systems
用于無菌以及無菌隔離器系統工藝驗證的專屬要求（新增）
The organization shall documentprocedures (see 4.2.4) for the validation of processesfor sterilization and sterile barrier systems.
組織應當建立文件化的程序（見4.2.4）用于無菌以及無菌隔離器系統工藝驗證（新增）
Processes for sterilization andsterile barrier systems shall be validated prior to implementation and followingproduct or process changes, as appropriate.
在產品實施前以及依據生產或工藝變更用于無菌以及無菌隔離器系統的工藝應當經過適當的驗證。（增加無菌隔離器內容）
Records of theresults and, conclusion of validation and necessary actions from the validationshall be maintained (see 4.2.4 and 4.2.5).
驗證結論和結果以及從驗證中引申出來的必要措施的（新增）相應記錄都應當予以保留。（見4.2.4和4.2.5）
NOTE Further information can befound in ISO 11607-1 and ISO 11607-2.
注：詳細的信息請參見ISO11607-1和ISO11607-2。（新增）
7.5.8 Identification 標識
The organizationshall document procedures for product identification and identify product bysuitable means throughout product realization.
組織應當在產品實現的全過程中，建立產品標識的文件化程序，并通過合適的意義來標識產品。
The organizationshall identify product status with respect to monitoring and measurement requirementsthroughout product realization. Identification of product status shall bemaintained throughout production, storage, installation and servicing ofproduct to ensure that only product that has passed the required inspectionsand tests or released under an authorized concession is dispatched, used orinstalled.
組織在產品的實現過程中應當依據監測和測量要對產品的狀態進行標識。產品狀態標識在產品生產、存儲、安裝和服務時都應當予以保留，從而保證只有通過必要的檢查和測試或在授權讓步下放行，設備才可以得以郵寄、使用或安裝。（原文在YY/T0287 7.5.3.3狀態標識項下）
If required by applicable regulatoryrequirements, the organization shall document a system to assign unique deviceidentification to the medical device.
如果相應的法律法規有要求，組織應當建立一個系統以便為醫療器械分配一個唯一的器械標識。（新增）
The organizationshall document procedures to ensure that medical devices returned to the organizationare identified and distinguished from conforming product.
組織應當建立程序來保證醫療器械返回組織時被標識清楚并與合格產品進行區分。
7.5.9 Traceability可追溯性
7.5.9.1 General總則
The organizationshall document procedures for traceability. These procedures shall define theextent of traceability in accordance with applicable regulatory requirementsand the records to be maintained (see 4.2.5).
組織應當建立可追溯性程序。依據相應的法律法規，這些程序應當界定清楚可追溯性范圍，相應的記錄應當予以保留（見4.2.5）。
刪減：YY/T0287中“有可追溯性要求的場合，組織應控制和記錄產品的唯一性標識(見 4.2.4)。”另外還有一個備注項。
7.5.9.2 Particular requirements for implantable medical devices
植入性醫療器械的專屬要求
The recordsrequired for traceability shall include records of components, materials, andconditions for the work environment used, if these could cause the medicaldevice not to satisfy its specified safety and performance requirements.
如果這些條件可能導致醫療器械不能滿足其安全和性能要求，用于追溯性的相關記錄應當包括組件、材料、使用的工作環境的條件等相關內容。
The organizationshall require that suppliers of distribution services or distributors maintainrecords of the distribution of medical devices to allow traceability and thatthese records are available for inspection.
組織應當要求銷售服務的供應商（代理商）或銷售員保留醫療器械的銷售記錄，以便于追溯，同時記錄可以用于檢查所需。
Records of thename and address of the shipping package consignee shall be maintained (see 4.2.5).
貨運包裝收件人的地址和名字的記錄應當予以保留。（見4.2.5）