7.5.4 Servicing activities 服務活動
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.
如果醫療器械的服務有特殊要去，組織應當建立相應服務程序，標準品和標準測量程序，如適用，來實施相應的服務活動和與產品要求相符合的驗證。
The organization shall analyses recordsof servicing activities carried out by the organization or its supplier:
組織應當分析由組織或其供應商（代理商）實施的服務活動的相關記錄：
a) to determine if the informationis to be handled as a complaint;
來確定是否信息作為抱怨來處理。
b) as appropriate, for input to theimprovement process.
如適用，可以作為改進過程的輸入。
Records of servicing activitiescarried out by the organization or its supplier shall be maintained (see 4.2.5). （新增）
由組織或其供應商（代理商）實施的服務活動的記錄應當予以保留.（見4.2.5）
刪減了，原來YY/T0287中的“在規定有服務要求的情況下，必要時，組織應建立用于服務提供活動并驗證該服務是否滿足規定要求的形成文件的程序、作業指導書、參考材料和測量程序。”以及一個備注內容。
7.5.5 Particular requirements for sterile medical devices 無菌醫療器械的專用要求
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.
組織應當記錄每一個滅菌批次所使用的滅菌工藝參數（見4.2.5）。滅菌記錄應當能夠追溯每個醫療器械生產批次。
7.5.6 Validation of processes for production and service provision 生產和服務提供的工藝驗證
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.
組織應當驗證任何用于生產和服務提供的工藝，因為輸出的結果通過監測或測量不可能或無法被證實，最終導致的結果是只有當產品被使用和交付時缺陷才被發現。
Validation shalldemonstrate the ability of these processes to achieve planned results consistently.
驗證應當證明這些工藝的能力，從而達到預期的一致性的結果。
The organizationshall document procedures for validation of processes, including:
組織應當建立工藝驗證的程序，包括：
a) definedcriteria for review and approval of the processes;
確定的審核和批準這些工藝的標準
b) equipmentqualification and qualification of personnel;
設備確認（性能確認）和人員的確認（指培訓）；
c) use ofspecific methods, procedures and acceptance criteria;
專屬方法的使用，程序和可接受標準；（新增）
d) asappropriate, statistical techniques with rationale for sample sizes;
如適用，針對樣本量的帶有依據性的統計學技術。
e) requirementsfor records (see 4.2.5);
記錄的要求（見4.2.5）；
f) revalidation, including criteria for revalidation;
再驗證，包括再驗證的標準。（新增）
g) approval of changes to theprocesses.
工藝變更的批準。（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.
組織應當建立用于生產和服務提供的計算機軟件應用驗證的程序。在初始使用之前，這些計算機應用軟件應當經過驗證，相應的，在其軟件變更或應用后也應進行驗證。與計算應用軟件有關的驗證和再驗證的專屬方法和活動應當與使用軟件相對應的風險等級相適應，包括產品符合標準能力的影響。
Records of the results and conclusion of validation and necessary actions from thevalidation shall 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）