7.5.4 Servicing activities 服務(wù)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(yī)療器械的服務(wù)有特殊要去，組織應(yīng)當(dāng)建立相應(yīng)服務(wù)程序，標(biāo)準(zhǔn)品和標(biāo)準(zhǔn)測量程序，如適用，來實施相應(yīng)的服務(wù)活動和與產(chǎn)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(yīng)當(dāng)分析由組織或其供應(yīng)商（代理商）實施的服務(wù)活動的相關(guān)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(yīng)商（代理商）實施的服務(wù)活動的記錄應(yīng)當(dāng)予以保留.（見4.2.5）
刪減了，原來YY/T0287中的“在規(guī)定有服務(wù)要求的情況下，必要時，組織應(yīng)建立用于服務(wù)提供活動并驗證該服務(wù)是否滿足規(guī)定要求的形成文件的程序、作業(yè)指導(dǎo)書、參考材料和測量程序?！币约耙粋€備注內(nèi)容。
7.5.5 Particular requirements for sterile medical devices 無菌醫(yī)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(yīng)當(dāng)記錄每一個滅菌批次所使用的滅菌工藝參數(shù)（見4.2.5）。滅菌記錄應(yīng)當(dāng)能夠追溯每個醫(yī)療器械生產(chǎn)批次。
7.5.6 Validation of processes for production and service provision 生產(chǎn)和服務(wù)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(yīng)當(dāng)驗證任何用于生產(chǎn)和服務(wù)提供的工藝，因為輸出的結(jié)果通過監(jiān)測或測量不可能或無法被證實，最終導(dǎo)致的結(jié)果是只有當(dāng)產(chǎn)品被使用和交付時缺陷才被發(fā)現(xiàn)。
Validation shalldemonstrate the ability of these processes to achieve planned results consistently.
驗證應(yīng)當(dāng)證明這些工藝的能力，從而達到預(yù)期的一致性的結(jié)果。
The organizationshall document procedures for validation of processes, including:
組織應(yīng)當(dāng)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(zhǔn)這些工藝的標(biāo)準(zhǔn)
b) equipmentqualification and qualification of personnel;
設(shè)備確認（性能確認）和人員的確認（指培訓(xùn)）；
c) use ofspecific methods, procedures and acceptance criteria;
專屬方法的使用，程序和可接受標(biāo)準(zhǔn)；（新增）
d) asappropriate, statistical techniques with rationale for sample sizes;
如適用，針對樣本量的帶有依據(jù)性的統(tǒng)計學(xué)技術(shù)。
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(biāo)準(zhǔn)。（新增）
g) approval of changes to theprocesses.
工藝變更的批準(zhǔn)。（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(yīng)當(dāng)建立用于生產(chǎn)和服務(wù)提供的計算機軟件應(yīng)用驗證的程序。在初始使用之前，這些計算機應(yīng)用軟件應(yīng)當(dāng)經(jīng)過驗證，相應(yīng)的，在其軟件變更或應(yīng)用后也應(yīng)進行驗證。與計算應(yīng)用軟件有關(guān)的驗證和再驗證的專屬方法和活動應(yīng)當(dāng)與使用軟件相對應(yīng)的風(fēng)險等級相適應(yīng)，包括產(chǎn)品符合標(biāo)準(zhǔn)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(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(dāng)予以保留。（見4.2.4和4.2.5）