7.5.7 Particular requirements for validation ofprocesses for sterilization and sterile
barrier systems
用于无菌以及无菌隔离器系统工艺验证的专属要求（新增）
The organization shall documentprocedures (see 4.2.4) for the validation of processesfor sterilization and sterile barrier systems.
组织应当建立文件化的程序（见4.2.4）用于无菌以及无菌隔离器系统工艺验证（新增）
Processes for sterilization andsterile barrier systems shall be validated prior to implementation and followingproduct or process changes, as appropriate.
在产品实施前以及依据生产或工艺变更用于无菌以及无菌隔离器系统的工艺应当经过适当的验证。（增加无菌隔离器内容）
Records of theresults and, conclusion of validation and necessary actions from the validationshall be maintained (see 4.2.4 and 4.2.5).
验证结论和结果以及从验证中引申出来的必要措施的（新增）相应记录都应当予以保留。（见4.2.4和4.2.5）
NOTE Further information can befound in ISO 11607-1 and ISO 11607-2.
注：详细的信息请参见ISO11607-1和ISO11607-2。（新增）
7.5.8 Identification 标识
The organizationshall document procedures for product identification and identify product bysuitable means throughout product realization.
组织应当在产品实现的全过程中，建立产品标识的文件化程序，并通过合适的意义来标识产品。
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.
组织在产品的实现过程中应当依据监测和测量要对产品的状态进行标识。产品状态标识在产品生产、存储、安装和服务时都应当予以保留，从而保证只有通过必要的检查和测试或在授权让步下放行，设备才可以得以邮寄、使用或安装。（原文在YY/T0287 7.5.3.3状态标识项下）
If required by applicable regulatoryrequirements, the organization shall document a system to assign unique deviceidentification to the medical device.
如果相应的法律法规有要求，组织应当建立一个系统以便为医疗器械分配一个唯一的器械标识。（新增）
The organizationshall document procedures to ensure that medical devices returned to the organizationare identified and distinguished from conforming product.
组织应当建立程序来保证医疗器械返回组织时被标识清楚并与合格产品进行区分。
7.5.9 Traceability可追溯性
7.5.9.1 General总则
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).
组织应当建立可追溯性程序。依据相应的法律法规，这些程序应当界定清楚可追溯性范围，相应的记录应当予以保留（见4.2.5）。
删减：YY/T0287中“有可追溯性要求的场合，组织应控制和记录产品的唯一性标识(见 4.2.4)。”另外还有一个备注项。
7.5.9.2 Particular requirements for implantable medical devices
植入性医疗器械的专属要求
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.
如果这些条件可能导致医疗器械不能满足其安全和性能要求，用于追溯性的相关记录应当包括组件、材料、使用的工作环境的条件等相关内容。
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.
组织应当要求销售服务的供应商（代理商）或销售员保留医疗器械的销售记录，以便于追溯，同时记录可以用于检查所需。
Records of thename and address of the shipping package consignee shall be maintained (see 4.2.5).
货运包装收件人的地址和名字的记录应当予以保留。（见4.2.5）