CE-可用性工程评估报告(EN-62366)

EN62366:2008Checklist/检查表MedicaldevicesApplicationofusabilityengineeringtomedicaldevices可用性工程于医疗器械的应用ProductName/产品名称ReportReferenceNo/编号.:Version/版本号：验证人：Dateofissue/发布日期:版本修改记录：日期版本说明验证人审批人Page2of11ReportIEC62366checklistClause条款Requirement要求Remark解释Verdict判定4GENERALREQUIREMENTS/总要求4.1GeneralRequirements/总要求4.1.1USABILITYENGINEERINGPROCESS/可用性工程过程HastheMANUFACTURERestablished,documentedandmaintainedaUSABILITYENGINEERINGPROCESStoprovideSAFETYforthePATIENT,USERandothersrelatedtoUSABILITYfortheproduct?制造商是否建立、记录并维持了一个可用性工程过程，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;ComplianceDoesthePROCESSaddressUSERINTERActionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENTincluding,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？UserManualCompliance4.1.2AreRESIDUALRISKSassociatedwithUSABILITYoftheMEDICALDEVICEpresumedtobeacceptable,unlessthereisOBJECTIVEEVIDENCEtothecontraryanddocumented?关系医疗器械可用性的剩余风险是否推定可接受？Riskanalysisreport;Compliance4.1.3MANUFACTURERSHALLsubjecttheinformationforsafetyusedasaRISKCONTROLtotheUSABILITYENGINEERINGPROCESS(e.g.,warningsorlimitationofuseintheACCOMPANYINGDOCUMENTS,marking,etc.).对于做为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;ComplianceDisregardingsuchinformationforSAFETYisconsideredbeyondanyfurtherreasonablemeansofRISKCONTROL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）RiskanalysisreportCompliance4.2TheresultsoftheUSABILITYENGINEERINGPROCESSarerecordedintheUSABILITYENGINEERINGFILE可用性工程过程的结果记录于可用性工程文档。Qualitymanual,proceduredocument;CompliancePage3of11ReportIEC62366checklistClause条款Requirement要求Remark解释Verdict判定TherecordsandotherdocumentsthatmakeuptheUSABILITYENGINEERINGFILEMAYformpartofotherdocumentsandfiles(e.g.,aMANUFACTURER’SproductdesignfileorRISKMANAGEMENTFILE),(SEEListofdocumentsmakeuptheUEfile)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,proceduredocumentCompliance4.3ScalingoftheUSABILITYENGINEERINGeffort/可用性工程的调整TheUSABILITYENGINEERINGPROCESSisscaledbasedonthesignificanceofanymodificationsdependingontheresultsoftheRISKANALYSISanddocumented可用性工程调整取决于风险分析确认的设计更改的重要程度RiskanalysisreportCompliance5USABILTYENGINEERINGPROCESS/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：--–intendedmedicalindication(e.g.,conditions(s)ordisease(s)tobescreened,monitored,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；UserManualCompliance–intendedPATIENTpopulation(e.g.,age,weight,health,condition);预期患者群，如年龄、体重、健康和社会条件；UserManualCompliance–intendedpartofthebodyortypeoftissueappliedtoorinteractedwith;预期使用的身体部位或组织；UserManualCompliance–intendedconditionsofuse(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；UserManualCompliancePage4of11ReportIEC62366checklistClause条款Requirement要求Remark解释Verdict判定–operatingprinciple(s)操作原理UserManualCompliance5.2Frequentlyusedfunctions/常用功能ArefrequentlyusedfunctionsthatinvolveUSERinteractionwiththeMEDICALDEVICEaredeterminedandrecordedintheUSABILITYENGINEERINGFILE?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？UserManualCompliance5.3IdentificationofHAZARDSandHAZARDOUSSITUATIONSrelatedtoUSABILITY/识别可用性相关的危害和危害处境5.3.1IdentificationofcharacteristicstoSAFETY/识别安全特征IdentificationofcharacteristicsrelatedtoSAFETY(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RiskanalysisreportComplianceDuringtheidentificationcharacteristicsrelatedtoSAFETY,thefollowingareconsidered:在识别安全特征时，要考虑下列因素：–applicationspecification,includingUSERPROFILE(S);and应用的规格，包括用户特征；–frequentlyusedfunctions.常用功能。UserManualComplianceResultsofthisidentificationcharacteristicsrelatedtoSAFETYrecordedintheUSABILITYENGINEERINGFILE安全特征识别的结果应记录于可用性工程文档UserManualCompliance5.3.2IdentificationofknownorforeseeableHAZARDSandHAZARDOUSSITUATIONS/识别已知的或可预见的危害和危害处境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RiskanalysisreportComplianceIdentificationofHAZARDSconsideredHAZARDStoPATIENTS,USERSandotherpersons识别危害时要考虑对患者、操作者和其他人员的危害RiskanalysisreportCompliancePage5of11ReportIEC62366checklistClause条款Requirement要求Remark解释Verdict判定ReasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheUSERINTERFACEthatcanresultinaHAZARDOUSSITUATIONassociatedwiththeMEDICALDEVICEwereidentified.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。RiskanalysisreportComplianceDuringtheidentificationofHAZARDSandHAZARDOUSSITUATIONS,thefollowingwasconsidered:在识别危害和危害处境时，下列需要考虑：–applicationspecification,includingUSERROFILE(S);应用的规格，包括用户特征；–taskrelatedrequirements;任务相关的要求；–contextofuse;使用的背景；–informationonHAZARDSandHAZARDOUSSITUATIONSknownforexistingUSERINTERFACESofMEDICALDEVICESofasimilartype,ifavailable;对于现存的类似的医疗器械用户界面的已知的危害和危害