CE-可用性工程评估报告

1、EN 62366:2008 Checklist/ 检查表Medical devicesApplication of usability engineering to medical devices可用性工程于医疗器械的应用Product Name/产品名称Report Referenee No/ 编号.Version/版本号：验证人：Date of issue/发布日期：版本修改记录:日期版本说明验证人审批人4GENERAL REQUIREMENT总要求Gen eral Requireme nts/总要求ENGINEERINPROCES呵 用性工程过程Has the MANUFACTURERt

2、ablished, docume nted and maintained a usability engineering process provide SAFETYfor thepatient uSERa nd othersrelated tousability for the product?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？User Man ual;Quality man ual, procedure docume nt;Complia neeDoes the P ROCESSiddress user iNTERAtion

3、s withthe medical DEViCEccording to theaccompanyingDOCUMENTcluding, but not limited totransport, storage, installation, operation, maintenan ce, repair and disposal?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？User Man ualComplia neeresidualrisks associated withusability of themedicaldevice pres

4、umed to be acceptable, unl ess there isobjective evidence the con trary anddocume nted?关系医疗器械可用性的剩余风险是否推定可接受？Risk an alysis report ;Complia neemanufacturer SHALJbject the in formation for safety used as arisk cONTROto the usabilityengineering PROCESvar nings or limitati on of use in the accompanying

5、 docum EiNTki ng, 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Risk an alysis report ;User Man ual;Complia neeDisregarding such informationfor SAFETYiscon sidered bey ond any further reas on able means of RISK CONTROL忽视安全信息的行为应被认为是超岀风险控制措施的 （即非正常使用）Risk an alysis reportComplia neeThe results of theUSABI

6、LITY ENGINEERINGROCESarerecorded in theusability engineering file可用性工程过程的结果记录于可用性工程文档。Quality man ual, procedure docume nt;Complia neeThe records and other docume nts that make up the USABILITY ENGINEERING FILE MArm part of other docume nts and files ., amanufacturedproduct desig n file orRISK manag

7、ement F)i,le(SEEList of documents make up the UE file)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Quality man ual, procedure docume ntComplia neeScali ng of theusability ENGINEERINGffort/可用性工程的调整The usability engineering PROCESScaled based onthe sig nifica nee of any modificati onsdepe nding on the r

8、esults of therisk ANALYSiSa nddocume nted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Risk an alysis reportComplia nee5USABILTY ENGINEERING PROCES可用 性工程过程Applicati on specificati on/应用的规格Applicatio n of MEDiCALDEViCEj n theusabilityengineering file, specified by themanufacturerand in cludes可用性工程文档中的医疗器械的应用由制造商决 定，包括：

9、-intended medical indication .,con diti on s(s) or disease(s) to be scree ned, mon itored, treated, diag no sed, or preve nted);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；User Man ualComplia nee-intendedPATiENTpopulation ., age, weight,health, con diti on);预期患者群，如年龄、体重、健康和社会条件；User Man ualComplia nee-intended

10、 part of the body or type of tissue applied to or in teracted with;预期使用的身体部位或组织；User Man ualComplia nee-intended conditions of use . environment in cludi ng hygie nic requireme nts, freque ncy of use, locati on, 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；User Man ualComplia neeoperating principle(s

11、)操作原理User Man ualComplia neeFreque ntly used fun ctio ns/常用功能Are freque ntly used fun cti ons that in volve USERin teracti on with the MedicalD EViCEaredeterm ined and recorded in theusabilityENGINEERING FILE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？User Man ualComplia neeIdentification ofHAZARDahd HAZARDO

12、USSTUATiONSelated tousability 识别可用性相关的危害和危害处境of characteristics tosafety 识别安全特征Identification of characteristics related toSAFET(part of aRISK ANALYSiSthat focuses onUSABiLiTYperformed accord ing to ISO 14971:2007,.应按ISO 14971:2007, 的要求识别专注于可用性的安 全特征Risk an alysis reportComplia neeDuring the identif

13、ication characteristics related toSAFETYthe follow ing are con sidered:在识别安全特征时，要考虑下列因素：applicati on specificati on, in clud inguserPROFILES); and应用的规格，包括用户特征；-frequently used functions.常用功能。User Man ualComplia neeResults of this identification characteristics related toSAFETYecorded in theusability

14、ENGINEERING FILE安全特征识别的结果应记录于可用性工程文档User Man ualComplia neeof known or foreseeableHAZARDSnd hazardousituation/s识别已知的或可预见的危害和危害处境manufacturers ide ntified known or foreseeable HAZARD(part of arisk ANALYSi)Srelated toUSABILITY according to ISO 14971:2007,.制造商要按ISO 14971:2007,的要求识别可用性相关 的已知的或可预见的危害Risk

15、 an alysis reportComplia neeIde ntificati on ofhazards nsideredhazard)patients USERS3nd other persons识别危害时要考虑对患者、操作者和其他人员的危害Risk an alysis reportComplia neeReas on ably foreseeable seque nces or comb in ati ons of eve nts in volv ing theUSERiNTERFACEthat can result in ahazardous situationassociated

16、with themedical DEVICEvereiden tified. TheSEVERiTYof the resulti ngpossibleHARMis determ in ed.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。Risk an alysis reportComplia neeDuring the ide ntification ofHAZARDS! ndhazardous SiTUATQiNSe follow ing was con sidered:在识别危害和危害处境时，下列需要考虑：applic

17、ati on specificati on, in clud inguserROFILE S);应用的规格，包括用户特征；task related requireme nts;任务相关的要求；-con text of use; 使用的背景；-in formati on onhazards nd hazardous situationknown for existinguser iNTERFACEof medicalDEViCESof a similar type, if available;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；-preliminaryuse scena

18、rios初步的使用情景；-possible use errors;可能的使用错误；if an in correct men tal model of theoperati on of themedical device n cause a useERROFtesult ing in ahazardous siTUATijcand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；-results of the review of theuser interface用户界面的评审结果。Risk an alysis reportUser Man ual、Complia neeThe res

19、ults of this ide ntificati on ofhazardshazardous siTUATiONSid SEVERiTYare recorded in the usability engineering file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。Risk an alysis reportComplia neeprimary operating function要 操作功能The man ufacturer has determ ined theprimaryoperating functions! recorded in theusability

20、ENGINEERING FILE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。User Man ualComplia neeThe in puts to theprimary operating functionsin clude freque ntly used fun cti ons and fun cti ons related toSAFETYof the MEDICALCEVICE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。User Man ualComplia neeUSABILITY SPECIFICATION 可用性规范MANUFACTURER/elop

21、ed a USABILITY SPECIFICATION recorded in theusability engineering files partof the USABILITY ENGINEERING PROCESS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。Quality man ual, procedure docume ntComplia neeThe usability SPECiFiCATiONecorded in usability ENGINEERING FIL.EThe USABILITY SPECIFICATIOmay be in te

22、grated into other specificati ons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。Qualitymanu al,procedure docume ntComplia neeThe USABILITY SPECIFICATIOMcludeS：可用性规范包括：applicati on specificati on;应用的规格；-PRIMARY OPERATING FUNCTIONS主要操作功能-HAZARDS!nd H AZARDOUSlTUATIONSelated to the Usability; and关系可用性的危害和危害处境-known

23、or foreseeableuse ERRORiSsociatedwith the M edicalcevice已知的或可预见的关系医疗器械的使用错误。User Ma nualRisk an alysis reportComplia neeThe USABILITY SPECiFiCATiONescribes at least:可用性规范至少要描述：-use scENARiorelated to theprimary operatingFUNCTiONSi ncludi ng关于主要操作功能的使用情景，包括：-frequent Use Scenarios, and常见的使用情景-reas on

24、 ably foreseeable worst caseUSE SCENARIOS合理可预见的最坏使用情景；User Ma nualRisk an alysis reportComplia nee-u SER| NTERFACgequirements for theprimaryoperating FUNCTioinclud ing those to mitigate RISK;主要操作功能对于用户界面的要求，包括降低风险的 那些；Risk an alysis reportComplia nee- Requirements for determining whetherprimaryopera

25、ting FUNCTIONS easily recog nizable by the USER用于决定主要操作功能是否易于被用户认知的要求Risk an alysis reportComplia neeUSABILITY VALIDATIONplan/ 可用性确认计划The manufacturers developed and maintains aUSABILITY VALIDATION）。n specifying:制造商需制定并维护可用性确认计划，以规定：User Ma nualComplia nee-any method used forvalidations the usabilit

26、yof the PRIMARY OPERATING FUNCTIONS对于主要操作功能的可用性的确认方法；User Ma nualComplia neethe criteria for determining successfulVALIDATIONof theUSABILITY of the PRIMARY OPERATINGFUNCTiONSased on theusability specifications nd基于可用性规范，对主要操作功能可用性的确认标准User Ma nualComplia nee-the involvement of representative intende

27、dUSERS包含的预期用户代表User Ma nualComplia neeusability VALiDATiorperformed in a laboratorysett ing 可用性确认实施的实验室设置：Test report.Complia neeusability VALiDATiorperformed in a simulated use environment 可用性确认实施于模拟使用环境：Test reportComplia neeusability VALiDATiorperformed in the actual use environment 可用性确认实施于真实使用环

28、境：Test reportComplia neeThe USABILITY VALiDATiorpian addresses:可用性确认计划包括：-frequent Use Scenarios, and常见的使用情景；-reas on ably foreseeable worst caseuseSCENARIOS合理可预见的最坏使用情景that are ide ntified in theusability specification都要在可用性规范中识别。User Ma nualComplia neeThe USABILITY VALiDATiOfplan recorded in the U

29、SABILITY ENGINEERING FILE可用性确认计划应记录与可用性工程文档。User Ma nualComplia neeUSER iNTERFACdesig n and impleme ntati on/用户界面设计和实施MANUFACTURgRsig ned and impleme nted theUSERiNTERFACBs described in theusabilitySPECiFiCATiONlJtilizi ng, as appropriate,USABILITYENGiNEERiNGiethods and tech ni ques制造商应使用可用性工程的方法和技术

30、来开发并实施 可用性规范描述的用户界面。Products do not have this requireme ntnon- complia neeUSABILITY VERIFICATION/ 可用性验证MANUFACTUR verified the impleme ntatio n of the MEdicalDEvice User iNTERFACEesig n accord ing to the USABILITY SPECIFICATION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。Products do not have this requireme ntnon- c

31、omplia neeThe results of the verification are recorded in USABILITY ENGINEERING FILE验证的结果应记录于可用性工程文档。Products do not have this requireme ntnon-complia neeUSABILITY VALIDATION 可用性确认The manufactures validated the Usability of themedicaldevice accordi ng to theusability validationpla n制造商应根据可用性确认计划来确认医

32、疗器械用户界 面的可用性。Products do not have this requireme ntnon-complia neeThe results are recorded in theusabilityENGINEERING FILE确认的结果应记录于可用性工程文档。Products do not have this requireme ntnon-complia neeFor the acceptanee criteria documented in the usability VALiDATiorpla n that are not met:对于没有可用性确认计划中制定的未被满足

33、的接收准 则：-further U SER 1 NTERFACEesign and impleme ntati on activities are performed; or 需要进行进一步的用户界面设计和执行；或-if further improvement is not practicable, the MANUFACTURER may gather and review data and literature to determine if the medicalben efits of the INTENDED USE outweigh the RISK aris ing from U

34、SABILITY problems如果进一步的改进不现实，制造商需要收集并评审数 据和文献，以确定预期用途的医疗收益是否超过可用 性问题带来的风险。To perform this step, the MANUFACTURER needs to estimate the RISK arising from USABILITY problems.为此，制造商需评估可用性问题带来的风险。Products do not have this requireme ntnon-complia nee6ACCOMPANYING DOCUMENTS/ 文件The A CCOMPANYING DOCUiMENTd

35、es a summary of the Medical device application specificatio n随机文件应包括医疗器械应用的规格的总结。User Man ualComplia neeA con cise description of the Medicaldevice itsoperat ing pr in ciples, sig nifica nt physical and performa nee characteristics and inten ded UserPROFiLEare in cluded in the Accompanying documen随机文件包括医疗器械、工作原理、重要的物理和性 能特性和预期用户的特征的简要描述。User Man ualTComplia neeThe ACCOMPANYING DOCUiMEWTtte n at a levelcon siste nt with the inten dedoperator profile随机文件的编写要与用户特征的水平相一致。User Man ualComplia