CE-可用性工程评价报告EN62366

1、MedicaldevicesApplicationofusabilityengineeringtomedicaldevices可用性工程于医疗器械的应用ProductName广 品名称ReportReferenceN。编号.:Version/版本号:验证人：.1_ _Dateofissue故布日期：I V I广I Ir-/IJ I/ 1j -、版本修改记录：日期版本说明验证人审批人欢送阅读EN62366:2021Checklist/检查表4 4GENERALREQUIREMENTS/总要求4.1GeneralRequirements总要求4.1.1USABILITYENGINEERINGPRO

2、CESS/可用性工程过程HastheMANUFACTURERestablished,documen tedandmaintainedaUSABILITYENGINEERINGPR OCESStoprovideSAFETYforthePATIENT,USERa ndothersrelatedtoUSABILITYfortheproduct?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 品适用性的人的平安？UserManual;Qualitymanual,proceduredocument;ComplianceDoesthePRocESsaddressjSERiN

3、TERA ctionswiththeMEDiCALDEViCE accordingtotheACCOMPANYiNGDOCUMENTincluding,butnotlimitedtotransport,storage,installation,operation,maintenance,re|airanddisposal?该过程是否用丁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、维修和废弁？UserManual叮- 一)Jl -/Compliance14.1.2AreRESiDUAL RiSKSassociatedwithUSABiLiTY oft heMEDiCA

4、LDEViCEpresumedtobeacceptable,unssthereiBJECTiVEEViDENCE tothecontraryanddocumented?关系医疗器械可用性的剩余风险是否推定可 接受？Riskanalysisreport;eCompliance4.1.3MANUFACTURERSHALLsubjecttheinformationf orsafetyusedasaRISKCONTROLtotheusABiLiTYENGINEERINGPROCESS(e.g.,warningsorlimit ationofuseintheACCOMPANYINGDOCUMENTS,

5、marking,etc.).对于做为风险控制措施的平安信息，制造冏 应把它纳入可用性工程过程的控制Riskanalysisreport;UserManual;ComplianceDisregardingsuchinformationforSAFETYisconsideredbeyondanyfurtherreasonablemeans ofRISKCONTROL无视平安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)RiskanalysisreportCompliance4.2ThereSUltSOftheUSABILITYENGINEERINGPROCESSarerecordedin

6、thusABiLiTYENGiNEERiNGFiLE可用性工程过程的结果记录丁可用性工程文档。Qualitymanual,proceduredocument;ComplianceTherecordsandotherdocumentsthatmakeuptheABILITYENGINEERINGFILEMAYformpartofotherdocumentsandfiles(e.g.,MANUFACTURER SproductdesignfileorRISKMANAGEMENTFILE ),(SEEListofdocumentsmakeuptheUEfile)组成可用性工程文档的记录和其它文件可以

7、 是其匕文档(如技术文档和风险菅理文档) 的局部Qualitymanual,proceduredocument rIi_Compliance4.3ScalingoftheUSABiLiTYENGINEERINGeffort/可用性工程的调整TheUSABiLiTYENGiNEERiNGPROCESS isscaledbasedonthesignificanceofanymodificationsdependigontheresultsofthRiSKANALYSiS anddocumentec可用性工程调整取决丁风险分析确认的设计 更改的重要程度Riskanalysisreportn1 .：

8、.z上1Compliance5 5USABILTYENGINEERINGPROCESS/可用性工程过程5.1Applicationspecification/应用的规格ApplicationofMEDICALDEViCEintheUSABiLiTYENGINEERINGFILEisspecifiedbytheMANUFACTURE Randincludes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)ordsease(s)tobescreened,monitored,treated,diagned

9、,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；UserManualosCompliance-intendedPATiENT population(e.g.,age,weight,heath,condition);预期患者群，如年龄、体重、健康和社会条件；UserManual lCompliance-intendedpartofthebodyortypeoftissueappliedtoointeractedwith;预期使用的身体部位或组织；UserManual rCompliance-intendedconditionsofuse(e.g.env

10、ironmentincluinghygienicrequirements,frequencyofuse,locatin,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；UserManualdoCompliance-operatingprinciple(s)操作原理UserManualirI 1 - -Compliance5.2Frequentlyusedfunctions/t用功能ArefrequentlyusedfunctionsthatinvolvelSERinteractionwiththeMEDICALDEVICEaredeterminedard

11、recordedinthejSABiLiTYENGiNEERiNGFiLE ?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？UserManual1 JCompliance5.3IdentificationofHAZARDS andHAZARDOUSSiTUATiONS relatedtojSABiLiTY /识别可用性相关的危害和危害处境5.3.1IdentificationofcharacteristicstcSAFETY/识别平安特征IdentificationofcharacteristicsrelatedtoAFETY(partofaRiSKANALYSiS )

12、thatfocusesoUSABiLiTY performedaccordingtoISO14971:2007,4.2.应按ISO14971:2007,4.2的要求识别专注于可 用性的平安特征RiskanalysisreportComplianceDuringtheidentificationcharacteristicsrelatedtoAFETY,thefollowingareconsidered:在识别平安特征时，要考虑卜列因素：-applicationspecification,includincjSERPROFiLE( S);and应用的规格，包括用户特征；frequentlyuse

13、dfunctions.常用功能。UserManualComplianceResultsofthisidentificationcharacteristicsrelatedOSAFETYreCOrdedintheJSABILITYENGINEERINGFILE平安特征识别的结果应记录丁可用性工程文档tUserManualCompliance5.3.2Identificationofknownorforeseea如AZARDSandHAZARDOUssITUATIONS /识别的或可预见的危害和危害处境MANUFACTURERhasidentifiedknownorforeseeab leHAZA

14、RDS(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的或可预见的危害RiskanysisreportComplianceIdentificationofHAZARDSconsideredHAZARDS topATIENTS,usERsandotherpersons识别危害时要考虑对患者、操作者和其他人 员的危害Riskanalysisreportl/ | .女、,- 11 /11 ,i/ComplianceReasonablyforese

15、eablesequencesorcombinathsofeventsinvolvingtheusERiNTERFACEthatcanresu ltinaHAZARDOUSSITUATIONassociatedwiththEDicALDEVICEwereidentified.ThesEVERiTYoftheresulti ngpossibleHARMisdetermined.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。)RiskanalysisreportComplianceDuringtheidentificationo

16、fHAZARDSandHAZARDousSITUATIONS,thefollowingwasconsidered:在识别危害和危害处境时，卜列需要考虑：-applicationspecification,includingUSERROFiLE；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,ifavaila

17、ble;对丁现存的类似的医疗器械用户界面的 的危害和危害处境信息；-preliminaryUSESCENARiOs;初步的使用情景；-possibleUSEERRORS;可能的使用错误； -ifanincorrectmentalmodeloftheoperationoftheMEDICALDEVICEcancauseUSEERRORresultinginsHAZARDOUSSITUATION;and操作医疗器械的错误精神模型是否会引起导 致危害处境的使用错误；-resultsofthereviewoftheUSERiNTERFACE用户界面的评审结果。RiskanalysisreportUse

18、rManual |1/ ： X . X | fCompliance7TRAININGANDMATERIALSFORTRAINING/培训和培训材料TherequiredtrainingontheiEDiCALDEViCE forsafeandeffectiveuseopRiMARYOPERATiNGFUNCTioNSbytheintendedUSERisgivenby:由预期用户平安有效使用医疗器械主要操作功能的必须培训包括：UserManualCompliance-necessarytrainingmaterialsprovidedbythemanu cturer;制造冏提供的必要的培训材料；UserManual faCompliance-necessarytrainingmaterialsareavailabor必要培训材料的可获得性；UserManualCompliance. ， . . .ThemanufacturerprovidesRAiNiNG或制造冏提供培训UserManualComplianceTheAccoMPANYiNGDOCUMENT des