7.5.4 Servicing activities 服務(wù)活動(dòng)
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(cè)量程序，如適用，來(lái)實(shí)施相應(yīng)的服務(wù)活動(dòng)和與產(chǎn)品要求相符合的驗(yàn)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(shí)施的服務(wù)活動(dòng)的相關(guān)記錄：
a) to determine if the informationis to be handled as a complaint;
來(lái)確定是否信息作為抱怨來(lái)處理。
b) as appropriate, for input to theimprovement process.
如適用，可以作為改進(jìn)過(guò)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(shí)施的服務(wù)活動(dòng)的記錄應(yīng)當(dāng)予以保留.（見(jiàn)4.2.5）
刪減了，原來(lái)YY/T0287中的“在規(guī)定有服務(wù)要求的情況下，必要時(shí)，組織應(yīng)建立用于服務(wù)提供活動(dòng)并驗(yàn)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(shū)、參考材料和測(cè)量程序。”以及一個(gè)備注內(nèi)容。
7.5.5 Particular requirements for sterile medical devices 無(wú)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(gè)滅菌批次所使用的滅菌工藝參數(shù)（見(jiàn)4.2.5）。滅菌記錄應(yīng)當(dāng)能夠追溯每個(gè)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(yàn)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(yàn)證任何用于生產(chǎn)和服務(wù)提供的工藝，因?yàn)檩敵龅慕Y(jié)果通過(guò)監(jiān)測(cè)或測(cè)量不可能或無(wú)法被證實(shí)，最終導(dǎo)致的結(jié)果是只有當(dāng)產(chǎn)品被使用和交付時(shí)缺陷才被發(fā)現(xiàn)。
Validation shalldemonstrate the ability of these processes to achieve planned results consistently.
驗(yàn)證應(yīng)當(dāng)證明這些工藝的能力，從而達(dá)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(yàn)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(rèn)（性能確認(rèn)）和人員的確認(rèn)（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(duì)樣本量的帶有依據(jù)性的統(tǒng)計(jì)學(xué)技術(shù)。
e) requirementsfor records (see 4.2.5);
記錄的要求（見(jiàn)4.2.5）；
f) revalidation, including criteria for revalidation;
再驗(yàn)證，包括再驗(yàn)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(jì)算機(jī)軟件應(yīng)用驗(yàn)證的程序。在初始使用之前，這些計(jì)算機(jī)應(yīng)用軟件應(yīng)當(dāng)經(jīng)過(guò)驗(yàn)證，相應(yīng)的，在其軟件變更或應(yīng)用后也應(yīng)進(jìn)行驗(yàn)證。與計(jì)算應(yīng)用軟件有關(guān)的驗(yàn)證和再驗(yàn)證的專屬方法和活動(dòng)應(yīng)當(dāng)與使用軟件相對(duì)應(yīng)的風(fēng)險(xiǎn)等級(jí)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(yàn)證結(jié)論和結(jié)果以及從驗(yàn)證中引申出來(lái)的必要措施的（新增）相應(yīng)記錄都應(yīng)當(dāng)予以保留。（見(jiàn)4.2.4和4.2.5）