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(tǒng)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(yīng)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(tǒng)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(chǎn)品實施前以及依據(jù)生產(chǎn)或工藝變更用于無菌以及無菌隔離器系統(tǒng)的工藝應(yīng)當經(jīng)過適當?shù)尿炞C。（增加無菌隔離器內(nèi)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(jié)論和結(jié)果以及從驗證中引申出來的必要措施的（新增）相應(yīng)記錄都應(yīng)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(yīng)當在產(chǎn)品實現(xiàn)的全過程中，建立產(chǎn)品標識的文件化程序，并通過合適的意義來標識產(chǎn)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(chǎn)品的實現(xiàn)過程中應(yīng)當依據(jù)監(jiān)測和測量要對產(chǎn)品的狀態(tài)進行標識。產(chǎn)品狀態(tài)標識在產(chǎn)品生產(chǎn)、存儲、安裝和服務(wù)時都應(yīng)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(quán)讓步下放行，設(shè)備才可以得以郵寄、使用或安裝。（原文在YY/T0287 7.5.3.3狀態(tài)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(yīng)的法律法規(guī)有要求，組織應(yīng)當建立一個系統(tǒng)以便為醫(yī)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(yīng)當建立程序來保證醫(yī)療器械返回組織時被標識清楚并與合格產(chǎn)品進行區(qū)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(yīng)當建立可追溯性程序。依據(jù)相應(yīng)的法律法規(guī)，這些程序應(yīng)當界定清楚可追溯性范圍，相應(yīng)的記錄應(yīng)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(yīng)控制和記錄產(chǎn)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(yī)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(yī)療器械不能滿足其安全和性能要求，用于追溯性的相關(guān)記錄應(yīng)當包括組件、材料、使用的工作環(huán)境的條件等相關(guān)內(nèi)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(yīng)當要求銷售服務(wù)的供應(yīng)商（代理商）或銷售員保留醫(yī)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(yīng)當予以保留。（見4.2.5）