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acceptance接收action措施activemedicaldevice有源医疗器械activeimplantablemedicaldevice有源植入性医疗器械adequacy充分性adjust调整adverseeffect不利影响advisorynotice忠告性通知agent代理商analysis分析analysisofdata数据分析applicable适用的application应用approval批准approved被批准associatedutility相关设施auditor内审员authority权限awareness意识batch批次building建筑物calibration校准calibrationstatus校准状态cause条款change更改characteristic特性cleanliness清洁clinicalevaluation临床评价clothing服装commitment义务communication沟通质量管理体系词汇中英文对照表BACconcession让步confidentialinformation保密信息conformity合格consistent持续的consistentwith与...相一致contamination污染contract合同controlofnonconformingproduct不合格品的控制controlofrecord记录控制controlofdocument文件控制correctiveaction纠正措施correctiveandpreventiveaction纠正预防措施criteria准则criteriaforselection选择的准则criteriaforproductacceptance产品的接收准则customercomplaint顾客抱怨customercommunication顾客沟通customerfocus以顾客为关注焦点customerfeedback顾客反馈customerproperty顾客财产customer-relatedprocess与顾客有关的过程customerrequirement顾客要求damage损坏deficiency不足define定义definedrequirement规定的要求delivery交付designanddevelopment设计和开发designanddevelopmentchange设计和开发更改designanddevelopmentinput设计和开发的输入designanddevelopmentoutput设计和开发的输出designanddevelopmentplanning设计和开发的策划designanddevelopmentreview设计和开发的评审designanddevelopmentverification设计和开发的验证designanddevelopmentvalidation设计和开发的确认Ddesigntransfer设计转换deterioration损坏distributor经销商document文件documentation文件documentedprocedure程序文件documentationrequirement文件要求effectiveness有效性efficiency效率eliminate消除enquiry咨询ensure确保esponsibility职责evaluate评价evaluationofperformance性能评价evidence证据experience经验extent程度feedbacksystem反馈系统file文档finalproduct最终产品framework框架frequency频率function功能functionalrequirement功能要求generalrequirement总要求handling搬运hardware硬件health健康humanresource人力资源identification标记IEFGHidentificationandtraceability标识和可追溯性impartiality公正性implantablemedicaldevice植入性医疗器械implementation实施improvement改进infrastructure基础设施input输入inspection检验installationprocess安装过程installationactivitie安装活动intendeduse预期用途internalaudit内审internalcommunication内部沟通interrelation相互关系interestedparty相关方invalidate使失效issue发布labelling标识lifetimeofthemedicaldevice器械的寿命lost丢失maintenance维护managementsystem管理体系managementreview管理评审managementrepresentative管理者代表manufacturingprocess生产过程measurement测量medicaldevice医疗器械monitoring监视monitoringandmeasurement监视和测量monitoringandmeasuringdevice监视和测量装置nationalorregionalregulation国家或地区标准nonconformity不合格NOLMobjectivity客观性order订单organizationstructure组织结构output输出package包装packaging包装particularrequirement特殊要求performance性能performancerequirement性能要求personnel人员planningofproductrealization产品实现的策划Passivemedicalequipment无源医疗器械post-delivery交付后post-productionstage生产后阶段preservationofproduct产品防护preventiveaction预防措施preventiveandcorrectiveactions纠正预防措施procedure程序process过程processperformance过程业绩product产品productacceptancecriteria产品接收准则productconformity产品的符合性productinformation产品信息productionprovision产品的提供productrequirement产品要求productrelease产品放行productrealization产品的实现productspecification产品规范project项目protection防护provisionofresource资源提供purchasing采购quality质量PQqualityassurance质量保证qualitycontrol质量控制qualityimprovement质量改进qualitymanagement质量管理qualitymanagementsystem质量管理体系qualitymanual质量手册qualityobjective质量目标qualityplanning质量计划qualitypolicy质量方针qualificationofpersonnel人员资格re-adjuste重新调整recommendationforimprovement改进的建议reconfirm重新确认record记录re-evaluation重新评价reference参考referencematerial参考材料referencemeasurementprocedure参考测量材料regulatoryrequirement法规要求release放行reportingadverseevent不良事件报告requirement要求resource资源resourcemanagement资源管理resourceneeds资源的需求resultsofaudit审核结果revalidation重新确认review评审reviewinput评审输入reviewoutput评审输出rework返工riskmanagement风险管理safety安全safetyrequirement安全要求RSsatisfy满足scope范围servicingactivitie服务活动servicingprocess服务过程serviceprovision服务的提供skill技能software软件specialenvironmentalcondition特殊环境条件specialstoragecondition特殊的贮存条件specialistpersonnel专家specifiedapplication规定的要求statisticaltechnique统计技术statusidentification状态标识statutoryrequirement法律要求sterilemedicaldevice无菌医疗器械sterilization灭菌storage贮存suitability适宜性supportingservice支持性服务system体系task工作temporarily临时地tender标书test试验topmanagement最高管理者traceability可追溯性training培训typeormodel类型或型号unintendeduse非预期用途update更新validation确认verification验证WUTVwarning报警workenvironment工作环境workinstruction作业指导书workspace工作场所