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1、EN62366:2008Checklist/检查表MedicaldevicesApplicationofusabilityengineeringtomedicaldevices可用性工程于医疗器械的应用ProductName/产品名称ReportRefereneeNo/编号.Version/版本号：验证人：Dateofissue/发布日期：版本修改记录：IEC62366checklistClauseRequirementRemarkVerdict条款要求解释判定4GENERALREQUIREMENTS/总要求4.1GeneralRequirements/总要求4.1.1UsabilityEng
2、ineeringProcess/可用性工程过程Hasthemanufacturerestablished,documentedandmaintainedausabilityengineeringprocesstoprovideSafetyforthepatient,userandothersrelatedtousabltyfortheproduct?制造商是否建立、记录并维持了个可用性工程过程，以确保患者、用户和其它涉及产品适用性的人的安全？UserManual;Qualitymanual,proceduredocument;ComplianeeDoestheProcessaddressuse
3、riNTERACtionswiththemedicaldeviceaccordingtotheaccompanyingdocumentincluding,butnotlimitedtotransport,storage,installation,operation,maintenance,repairanddisposal?该过程是否用于解决用户按随机文件与医疗器械的交互，如运输、存储、安装、操作、维护、维修和废弃？UserManualComplianee4.1.2AreResidualRisksassociatedwithUsabilityofthemedqalDevIcepresumedt
4、obeacceptable,unlessthereisobjectiveevidencetothecontraryanddocumented?关系医疗器械可用性的剩余风险是否推定可接受？Riskanalysisreport;Complianee4.1.3manufacturershallsubjecttheinformationforsafetyusedasariskcontroltotheusabilityengineeringprocess(e.g.,warningsorlimitationofuseintheaccompanyingdocuments,marking,etc.).对于做为
5、风险控制措施的安全信息，制造商应把它纳入可用性工程过程的控制Riskanalysisreport;UserManual;ComplianeeDisregardingsuchinformationforsafetyisconsideredbeyondanyfurtherreasonablemeansofRISKCONTROL忽视安全信息的行为应被认为是超出风险控制措施的(即非正常使用)RiskanalysisreportComplianee4.2Theresultsoftheusabilityengineeringprocessarerecordedintheusabilityengineeri
6、ngfile可用性工程过程的结果记录于可用性工程文档。Qualitymanual,proceduredocument;ComplianeeIEC62366checklistClauseRequirementRemarkVerdict条款要求解释判定Therecordsandotherdocumentsthatmakeuptheusabilityengineeringfilemayformpartofotherdocumentsandfiles(e.g.,amanufacturersproductdesignfileorriskmanagementfile),(seeListofdocument
7、smakeuptheUEfile)组成可用性工程文档的记录和其它文件可以是其它文档(如技术文档和风险管理文档)的一部分Qualitymanual,proceduredocumentComplianee4.3ScalingoftheUsabilityEngineeringeffort/可用性工程的调整TheusabilityengineeringprocessisscaledbasedonthesignificaneeofanymodificationsdependingontheresultsoftherIskanalyseanddocumented可用性工程调整取决于风险分析确认的设计更改的
8、重要程度RiskanalysisreportComplianee5USABILTYENGINEERINGPROCESS/可用性工程过程5.1Applicationspecification/应用的规格ApplicationofMedicalDeviceintheusabilityengineeringfileisspecifiedbythemanufacturerandincludes可用性工程文档中的医疗器械的应用由制造商决定，包括：一intendedmedicalindication(e.g.,conditions(s)ordisease(s)tobescreened,monitored,
9、treated,diagnosed,orprevented);预期医学用途，如预期要筛查、监护、治疗、诊断或预防的状态或疾病；UserManualComplianee一intendedPATIENTpopulation(e.g.,age,weight,health,condition);预期患者群，如年龄、体重、健康和社会条件；UserManualComplianee一intendedpartofthebodyortypeoftissueappliedtoorinteractedwith;预期使用的身体部位或组织；UserManualComplianee一intendedconditionso
10、fuse(e.g.environmentincludinghygienicrequirements,frequencyofuse,location,mobility);and预期的使用状态，如环境包括卫生要求、使用频度、地点和机动性；UserManualComplianeeIEC62366checklistClauseRequirementRemarkVerdict条款要求解释判定一operatingprinciple(s)操作原理UserManualComplianee5.2Frequentlyusedfunctions/常用功能Arefrequentlyusedfunctionsthati
11、nvolveUserinteractionwiththeMeDIcalDeVIcearedeterminedandrecordedintheusabilityengineeringfile?在可用性工程文档中是否确定并记录了涉及用户与医疗器械交互的常用功能？UserManualComplianee5.3Identificationofhazardsandhazardoussituationsrelatedtousability/识别可用性相关的危害和危害处境5.3.1Identificationofcharacteristicstosafety/识另U安全特征Identificationofc
12、haracteristicsrelatedtosafety(partofariskanalysis)thatfocusesonusabilityperformedaccordingtoISO14971:2007,4.2.应按ISO14971:2007,4.2的要求识别专注于可用性的安全特征RiskanalysisreportComplianeeDuringtheidentificationcharacteristicsrelatedtosafety,thefollowingareconsidered:在识别安全特征时，要考虑下列因素：一applicationspecification,incl
13、udinguserprofile(s);and应用的规格，包括用户特征；-frequentlyusedfunctions.常用功能。UserManualComplianeeResultsofthisidentificationcharacteristicsrelatedtosafetyrecordedintheusabilityengineeringfile安全特征识别的结果应记录于可用性工程文档UserManualComplianee5.3.2Identificationofknownorforeseeablehazardsandhazardoussituations/识别已知的或可预见的危
14、害和危害处境manufacturerhasidentifiedknownorforeseeablehazards(partofariskanalysis)relatedtoUSABILITYaccordingtoISO14971:2007,4.3.制造商要按ISO14971:2007,4.3的要求识别可用性相关的已知的或可预见的危害RiskanalysisreportComplianeeIdentificationofhazardsconsideredhazardstopatients,usersandotherpersons识别危害时要考虑对患者、操作者和其他人贝的危害Riskanalysi
15、sreportComplianeeIEC62366checklistClauseRequirementRemarkVerdict条款要求解释判定Reasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheuserinterfacethatcanresultinahazardoussituationassociatedwiththemedqaldevqewereidentified.ThesevERItyoftheresultingpossibleharmisdetermined.包括可能导致危害处境的医疗器械用户界面的合理可预见的事件的次序和组合已经被识别。导致的可能的危害的严重程度已确定。RiskanalysisreportComplianeeDuringtheidentificationofha
