CE可用性工程评估报告材料EN62366.docx
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CE可用性工程评估报告材料EN62366
EN62366:
2008Checklist/检查表
Medicaldevices
Applicationofusabilityengineeringtomedicaldevices
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
4
GENERALREQUIREMENTS/总要求
4.1
GeneralRequirements/总要求
4.1.1
UsabilityEngineeringProcess/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;
Compliance
DoestheProcessaddressuserinteractionswiththemedicaldeviceaccordingtotheaccompanyingdocumentincluding,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?
UserManual
Compliance
4.1.2
AreResidualRisksassociatedwithUsabilityofthemedicalDevicepresumedtobeacceptable,unlessthereisobjectiveevidencetothecontraryanddocumented?
关系医疗器械可用性的剩余风险是否推定可接受?
Riskanalysisreport;
Compliance
4.1.3
manufacturershallsubjecttheinformationforsafetyusedasariskcontroltotheusabilityengineeringprocess(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;
Compliance
Disregardingsuchinformationforsafetyisconsideredbeyondanyfurtherreasonablemeansofriskcontrol
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)
Riskanalysisreport
Compliance
4.2
Theresultsoftheusabilityengineeringprocessarerecordedintheusabilityengineeringfile
可用性工程过程的结果记录于可用性工程文档。
Qualitymanual,proceduredocument;
Compliance
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,proceduredocument
Compliance
4.3
ScalingoftheUsabilityEngineeringeffort/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
Riskanalysisreport
Compliance
5
USABILTYENGINEERINGPROCESS/可用性工程过程
5.1
Applicationspecification/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;
UserManual
Compliance
–intendedpatientpopulation(e.g.,age,weight,health,condition);
预期患者群,如年龄、体重、健康和社会条件;
UserManual
Compliance
–intendedpartofthebodyortypeoftissueappliedtoorinteractedwith;
预期使用的身体部位或组织;
UserManual
Compliance
–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;
UserManual
Compliance
–operatingprinciple(s)
操作原理
UserManual
Compliance
5.2
Frequentlyusedfunctions/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?
UserManual
Compliance
5.3
Identificationofhazardsandhazardoussituationsrelatedtousability/识别可用性相关的危害和危害处境
5.3.1
Identificationofcharacteristicstosafety/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
Riskanalysisreport
Compliance
Duringtheidentificationcharacteristicsrelatedtosafety,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。
UserManual
Compliance
Resultsofthisidentificationcharacteristicsrelatedtosafetyrecordedintheusabilityengineeringfile
安全特征识别的结果应记录于可用性工程文档
UserManual
Compliance
5.3.2
Identificationofknownorforeseeablehazardsandhazardoussituations/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
Riskanalysisreport
Compliance
Identificationofhazardsconsideredhazardstopatients,usersandotherpersons
识别危害时要考虑对患者、操作者和其他人员的危害
Riskanalysisreport
Compliance
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。
Riskanalysisreport
Compliance
DuringtheidentificationofHAZARDSandHAZARDOUSSITUATIONS,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处境信息;
–preliminaryUSESCENARIOS;
初步的使用情景;
–possibleUSEERRORS;
可能的使用错误;
–ifanincorrectmentalmodeloftheoperationoftheMEDICALDEVICEcancauseaUSEERRORresultinginaHAZARDOUSSITUATION;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。
Riskanalysisreport
UserManual
Compliance
TheresultsofthisidentificationofHAZARDS,HAZARDOUSSITUATIONSandSEVERITYarerecordedintheUSABILITYENGINEERINGFILE.
识别危害、危害处境和严重程度的结果要记录在可用性工程文档里。
Riskanalysisreport
Compliance
5.4
Primaryoperatingfunctions/主要操作功能
Themanufacturerhasdeterminedtheprimaryoperatingfunctionsandrecordedintheusabilityengineeringfile
制造商已经确定了主要操作功能并记录在可用性工程文档里。
UserManual
Compliance
TheinputstotheprimaryoperatingfunctionsincludefrequentlyusedfunctionsandfunctionsrelatedtoSafetyoftheMedicalDevice
主要操作功能的输入包括常用功能和关系医疗器械安全的功能。
UserManual
Compliance
5.5
UsabilitySpecification/可用性规范
manufacturerdevelopedausabilityspecificationrecordedintheusabilityengineeringfileaspartoftheusabilityengineeringprocess
制造商应制定可用性规范,记录于可用性工程文档里作为可用性工程过程的一部分。
Qualitymanual,proceduredocument
Compliance
Theusabilityspecificationrecordedinusabilityengineeringfile.Theusabilityspecificationmaybeintegratedintootherspecifications
可用性规范记录于可用性工程文档里。
可用性规范可以整合于其它规范。
Qualitymanual,proceduredocument
Compliance
Theusabilityspecificationincludes:
可用性规范包括:
–applicationspecification;
应用的规格;
–primaryoperatingfunctions
主要操作功能
–hazardsandHazardousSituationsrelatedtotheUsability;and
关系可用性的危害和危害处境
–knownorforeseeableuseerrorsassociatedwiththeMedicalDevice
已知的或可预见的关系医疗器械的使用错误。
UserManual
Riskanalysisreport
Compliance
Theusabilityspecificationdescribesatleast:
可用性规范至少要描述:
–usescenariosrelatedtotheprimaryoperatingfunctions,including
关于主要操作功能的使用情景,包括:
–frequentUseScenarios,and
常见的使用情景
–reasonablyforeseeableworstcase
UseScenarios;
合理可预见的最坏使用情景;
UserManual
Riskanalysisreport
Compliance
–UserInterfacerequirementsfortheprimaryoperatingfunctions,includingthosetomitigateRisk;
主要操作功能对于用户界面的要求,包括降低风险的那些;
Riskanalysisreport
Compliance
–RequirementsfordeterminingwhetherprimaryoperatingfunctionsareeasilyrecognizablebytheUser.
用于决定主要操作功能是否易于被用户认知的要求
Riskanalysisreport
Compliance
5.6
Usabilityvalidationplan/可用性确认计划
Themanufacturerhasdevelopedandmaintainsausabilityvalidationplanspecifying:
制造商需制定并维护可用性确认计划,以规定:
UserManual
Compliance
–anymethodusedforvalidationoftheusabilityoftheprimaryoperatingfunctions;
对于主要操作功能的可用性的确认方法;
UserManual
Compliance
–thecriteriafordeterminingsuccessfulvalidationoftheusabilityoftheprimaryoperatingfunctionsbasedontheusabilityspecification;and
基于可用性规范,对主要操作功能可用性的确认标准
UserManual
Compliance
–theinvolvementofrepresentativeintendedusers
包含的预期用户代表
UserManual
Compliance
usabilityvalidationperformedinalaboratorysetting:
可用性确认实施的实验室设置:
Testreport.
Compliance
usabilityvalidationperformedinasimulateduseenvironment:
可用性确认实施于模拟使用环境:
Testreport
Compliance
usabilityvalidationperformedintheactualuseenvironment:
可用性确认实施于真实使用环境:
Testreport
Compliance
Theusabilityvalidationplanaddresses:
可用性确认计划包括:
–frequentUseScenarios,and
常见的使用情景;
–reasonablyforeseeableworstcaseusescenarios
合理可预见的最坏使用情景
thatareidentifiedintheusabilityspecification
都要在可用性规范中识别。
UserManual
Compliance
Theusabilityvalidationplanrecordedintheusabilityengineeringfile
可用性确认计划应记录与可用性工程文档。
UserManual
Compliance
5.7
Userinterfacedesignandimplementation/用户界面设计和实施
ManufacturerdesignedandimplementedtheuserinterfaceasdescribedintheusabilitySpecificationutilizing,asappropriate,usabilityengineeringmethodsandtechniques
制造商应使用可用性工程的方法和技术来开发并实施可用性规范描述的用户界面。
Productsdonothavethisrequirement
non-compliance
5.8
Usabilityverification/可用性验证
ManufacturerverifiedtheimplementationoftheMedicalDeviceUserinterfacedesignaccordingtotheusabilityspecification
制造商应根据可用性规范来验证医疗器械用户界面设计的实施。