7.5.4 Servicing activities 服务活动
If servicing of the medical deviceis a specified requirement, the organization shall document servicing procedures,reference materials, and reference measurements, as necessary, for performingservicing activities and verifying that product requirements are met.
如果医疗器械的服务有特殊要去，组织应当建立相应服务程序，标准品和标准测量程序，如适用，来实施相应的服务活动和与产品要求相符合的验证。
The organization shall analyses recordsof servicing activities carried out by the organization or its supplier:
组织应当分析由组织或其供应商（代理商）实施的服务活动的相关记录：
a) to determine if the informationis to be handled as a complaint;
来确定是否信息作为抱怨来处理。
b) as appropriate, for input to theimprovement process.
如适用，可以作为改进过程的输入。
Records of servicing activitiescarried out by the organization or its supplier shall be maintained (see 4.2.5). （新增）
由组织或其供应商（代理商）实施的服务活动的记录应当予以保留.（见4.2.5）
删减了，原来YY/T0287中的“在规定有服务要求的情况下，必要时，组织应建立用于服务提供活动并验证该服务是否满足规定要求的形成文件的程序、作业指导书、参考材料和测量程序。”以及一个备注内容。
7.5.5 Particular requirements for sterile medical devices 无菌医疗器械的专用要求
The organizationshall maintain records of the sterilization process parameters used for each sterilizationbatch (see 4.2.5). Sterilization records shall be traceableto each production batch of medical devices.
组织应当记录每一个灭菌批次所使用的灭菌工艺参数（见4.2.5）。灭菌记录应当能够追溯每个医疗器械生产批次。
7.5.6 Validation of processes for production and service provision 生产和服务提供的工艺验证
The organizationshall validate any processes for production and service provision where theresulting output cannot be or is not verified by subsequent monitoring ormeasurement and, as a consequence, deficiencies become apparent only after theproduct is in use or the service has been delivered.
组织应当验证任何用于生产和服务提供的工艺，因为输出的结果通过监测或测量不可能或无法被证实，最终导致的结果是只有当产品被使用和交付时缺陷才被发现。
Validation shalldemonstrate the ability of these processes to achieve planned results consistently.
验证应当证明这些工艺的能力，从而达到预期的一致性的结果。
The organizationshall document procedures for validation of processes, including:
组织应当建立工艺验证的程序，包括：
a) definedcriteria for review and approval of the processes;
确定的审核和批准这些工艺的标准
b) equipmentqualification and qualification of personnel;
设备确认（性能确认）和人员的确认（指培训）；
c) use ofspecific methods, procedures and acceptance criteria;
专属方法的使用，程序和可接受标准；（新增）
d) asappropriate, statistical techniques with rationale for sample sizes;
如适用，针对样本量的带有依据性的统计学技术。
e) requirementsfor records (see 4.2.5);
记录的要求（见4.2.5）；
f) revalidation, including criteria for revalidation;
再验证，包括再验证的标准。（新增）
g) approval of changes to theprocesses.
工艺变更的批准。（新增）
The organizationshall document procedures for the validation of the application of computersoftware used in production and service provision. Such software applicationsshall be validated prior to initial use and, as appropriate, after changes tosuch software or its application. The specific approach and activities associatedwith software validation and revalidation shall be proportionate to the risk associatedwith the use of the software, including the effect on the ability of theproduct to conform to specifications.
组织应当建立用于生产和服务提供的计算机软件应用验证的程序。在初始使用之前，这些计算机应用软件应当经过验证，相应的，在其软件变更或应用后也应进行验证。与计算应用软件有关的验证和再验证的专属方法和活动应当与使用软件相对应的风险等级相适应，包括产品符合标准能力的影响。
Records of the results and conclusion of validation and necessary actions from thevalidation shall 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）