CE可用性工程評(píng)估報(bào)告EN

1、EN 62366: 2008Checkl i st / 檢查表Medical devicesApplication of usability engineering to medical devices可用性工程于醫(yī)療器械的應(yīng)用Product Name/產(chǎn)品名稱Report Reference No/ 編號(hào).Version/版本號(hào)：驗(yàn)證人：Date of issue/ 發(fā)布日期：版本修改記錄：日期版本說(shuō)明驗(yàn)證人審批人4GENERAL REQUIREMENT 求General Requirements/ 總要求ENGINEERINPROCESST用性工程過(guò)程Has the MANUFACTURE

2、Rtablished, documented and maintained a usability engineering process provide SAFETYfor thepatient uSERand othersrelated to usability for the product制造商是否建立、記錄并維持了一個(gè)可用性工程過(guò) 程，以確?；颊?、用戶和其它涉及產(chǎn)品適用性的人的 安全User Manual;Quality manual, procedure document;ComplianceDoes the P ROCESSiddress USER iNTERAtions wit

3、h the medical DEViCBccording to theaccompanyingDOCUMENTcluding, but not limited to transport, storage, installation, operation, maintenance, repair and disposal該過(guò)程是否用于解決用戶按隨機(jī)文件與醫(yī)療器械的 交互，如運(yùn)輸、存儲(chǔ)、安裝、操作、維護(hù)、維修和 廢棄？User ManualComplianceRESIDUALRISKS associated withUSABILITY of themedicaldevice presumed to

4、 be acceptable, unless there isobjective evidenqe the contrary anddocumented關(guān)系醫(yī)療器械可用性的剩余風(fēng)險(xiǎn)是否推定可接受？Risk analysis report ;ComplianceMANUFACTURER SHAubject the information for safety used as arisk controLd the usabilityengineering PROCESSvarnings or limitation of use in the accompanying docum EiNTking,

5、 etc.）.對(duì)于做為風(fēng)險(xiǎn)控制措施的安全信息，制造商應(yīng)把它納 入可用性工程過(guò)程的控制Risk analysis report ;User Manual;ComplianceDisregarding such information for SAFETYis considered beyond any further reasonable means of RISK CONTROL忽視安全信息的行為應(yīng)被認(rèn)為是超出風(fēng)險(xiǎn)控制措施的 （即非正常使用）Risk analysis reportComplianceThe results of theUSABILITY ENGINEERINGROCESare

6、recorded in theusability engineering file可用性工程過(guò)程的結(jié)果記錄于可用性工程文檔。Quality manual, procedure document;ComplianceThe records and other documents that make up the USABILITY ENGINEERING FILE MArm part of other documents and files ., amanufactuR eisproduct design file orRISK management 甲,le(SEEList of docume

7、nts make up the UE file)組成可用性工程文檔的記錄和其它文件可以是其它文 檔(如技術(shù)文檔和風(fēng)險(xiǎn)管理文檔)的一部分Quality manual, procedure documentComplianceScaling of theusability ENGINEERINieffort/可用性工程的調(diào)整The usability engineering PROCEsscaled based on the significance of any modifications depending on the results of therisk ANALYSisanddocume

8、nted可用性工程調(diào)整取決于風(fēng)險(xiǎn)分析確認(rèn)的設(shè)計(jì)更改的重 要程度Risk analysis reportCompliance5USABILTY ENGINEERING PROCESSW生工程過(guò)程Application specification/應(yīng)用的規(guī)格Application of Medicaldevice in theusabilityengineering file, specified by theMANUFACTURERand includes可用性工程文檔中的醫(yī)療器械的應(yīng)用由制造商決 定，包括：-intended medical indication ., conditions(s

9、) or disease(s) to be screened, monitored, treated, diagnosed, or prevented);預(yù)期醫(yī)學(xué)用途，如預(yù)期要篩查、監(jiān)護(hù)、治療、診斷或 預(yù)防的狀態(tài)或疾病；User ManualComplianceintendedPATiENTpopulation ., age, weight,health, condition);預(yù)期患者群，如年齡、體重、健康和社會(huì)條件；User ManualComplianceintended part of the body or type of tissue applied to or interacte

10、d with;預(yù)期使用的身體部位或組織；User ManualComplianceintended conditions of use . environment including hygienic requirements, frequency of use, location, mobility);and預(yù)期的使用狀態(tài)，如環(huán)境包括衛(wèi)生要求、使用頻度、 地點(diǎn)和機(jī)動(dòng)性；User ManualComplianceoperating principle(s)操作原理User ManualComplianceFrequently used functions/常用功能Are frequently

11、used functions that involve USERinteraction with the MedicalD EVICEaredetermined and recorded in theusabilityENGINEERING FILE在可用性工程文檔中是否確定并記錄了涉及用戶與醫(yī) 療器械交互的常用功能？User ManualComplianceIdentification ofHAZARDSnd HAZARDOUSiTUATiONSelated tousability 識(shí)另1J可用性相關(guān)的危害和危害處境of characteristics tosafety 識(shí)別安全特征Iden

12、tification of characteristics related toSAFETXpart of arisk ANALYSiSthat focuses onUSABiLiTYperformed according to ISO 14971:2007,.應(yīng)按ISO 14971:2007,的要求識(shí)別專注十可用性的安全特征Risk analysis reportComplianceDuring the identification characteristics related toSAFETYthe following are considered:在識(shí)別安全特征時(shí)，要考慮下列因素：ap

13、plication specification, includinguserprofiles); and應(yīng)用的規(guī)格，包括用戶特征；frequently used functions.常用功能。User ManualComplianceResults of this identification characteristics related toSAFETYecorded in theusabilityENGINEERING FILE安全特征識(shí)別的結(jié)果應(yīng)記錄于可用性工程文檔User ManualComplianceof known or foreseeableHAZARDSnd HAZARDO

14、USITUATIONS識(shí)另ij 已知的或可預(yù)見(jiàn)的危害和危害處境manufacturers identified known or foreseeable HAZARD(part of aRISK ANALYSiSrelated toUSABILITY according to ISO 14971:2007,.制造尚要按ISO 14971:2007,的要求識(shí)別可用性相關(guān)的已知的或可預(yù)見(jiàn)的危害Risk analysis reportComplianceIdentification ofHAZARDconsideredhazard®patients uSERSand other perso

15、ns識(shí)別危害時(shí)要考慮對(duì)患者、操作者和其他人員的危害Risk analysis reportComplianceReasonably foreseeable sequences or combinations of events involving theUSERiNTERFACEthat can result in ahazardous situationassociated with themedical DEVICEwereidentified. TheSEVERITYof the resultingpossibleHARMis determined.包括可能導(dǎo)致危害處境的醫(yī)療器械用戶界面

16、的合理 可預(yù)見(jiàn)的事件的次序和組合已經(jīng)被識(shí)別。導(dǎo)致的可 能的危害的嚴(yán)重程度已確定。Risk analysis reportComplianceDuring the identification ofHAZARDSindhazardous SiTUATioNSe following was considered:在識(shí)別危害和危害處境時(shí)，下列需要考慮：application specification, includinguserrofilE S);應(yīng)用的規(guī)格，包括用戶特征；task related requirements;任務(wù)相關(guān)的要求；context of use;使用的背景； informa

17、tion onHAZARDSind hazardous situationknown for existinguser iNTERFACEof medicalDEViCESof a similar type, if available;對(duì)于現(xiàn)存的類似的醫(yī)療器械用戶界面的已知的危害和危害處境信息；preliminaryuse scenarios初步的使用情景；possible USE ERRORS;可能的使用錯(cuò)誤；if an incorrect mental model of theoperation of themedical DEViCEan cause a useERROResulting

18、 in ahazardous SiTUATiOnd操作醫(yī)療器械的錯(cuò)誤精神模型是否會(huì)引起導(dǎo)致危害處境的使用錯(cuò)誤；results of the review of theuser interface用戶界面的評(píng)審結(jié)果。Risk analysis reportUser ManualSComplianceThe results of this identification ofhazardshazardous SiTUATioNnd SEVERiTYare recorded in the usability engineering file識(shí)別危害、危害處境和嚴(yán)重程度的結(jié)果要記錄在可 用性工程文檔里。

19、Risk analysis reportCompliancePrimary operating functions 操作功能The manufacturer has determined the PRIMARY OPERATING FUNCTION-SI recorded in theUSABILITYENGINEERING FILE制造商已經(jīng)確定了主要操作功能并記錄在可用性工程 文檔里。User ManualComplianceThe inputs to theprimary operating functionsinclude frequently used functions and f

20、unctions related toSAFETYof the MEDICALDEVICE主要操作功能的輸入包括常用功能和關(guān)系醫(yī)療器械安 全的功能。User ManualComplianceUSABILITY SPECIFICATION 可用性規(guī)范MANUFACTUREeVeloped a USABILITY SPECIFICATION recorded in theusability engineering files partof the USABILITY ENGINEERING PROCESS制造商應(yīng)制定可用性規(guī)范，記錄于可用性工程文檔 里作為可用性工程過(guò)程的一部分。Quality m

21、anual, procedure documentComplianceThe usability SPECiFiCATiONecorded in usability ENGINEERING FILEThe USABILITY SPECIFICATIOmay be integrated into other specifications可用性規(guī)范記錄于可用性工程文檔里?？捎眯砸?guī)范 可以整合于其它規(guī)范。Qualitymanual,procedure documentComplianceThe USABILITY SPECiFiCATiOIncludes:可用性規(guī)范包括：application sp

22、ecification;應(yīng)用的規(guī)格；PRIMARY OPERATING FUNCTIONS主要操作功能HAZARDSind H AZARDOUSTUATIONSelated to the Usability; and關(guān)系可用性的危害和危害處境known or foreseeableuse ERROfOssociatedwith the M edicaldevice已知的或可預(yù)見(jiàn)的關(guān)系醫(yī)療器械的使用錯(cuò)誤。User ManualRisk analysis reportComplianceThe USABILITY SPECiFiCATiONescribes at least:可用性規(guī)范至少要描述：

23、use scENARiorelated to theprimary operatingFUNCTiONSincluding關(guān)于主要操作功能的使用情景，包括：frequent Use Scenarios, and常見(jiàn)的使用情景reasonably foreseeable worst caseUSE SCENARIOS合理可預(yù)見(jiàn)的最壞使用情景；User ManualRisk analysis reportComplianceU SERI NTERFACEequirements for theprimaryoperating FUNCTioNicluding those to mitigate RI

24、SK;主要操作功能對(duì)于用戶界面的要求，包括降低風(fēng)險(xiǎn)的 那些；Risk analysis reportComplianceRequirements for determining whetherprimaryoperating FUNCTIONS easily recognizable by the USER用于決定主要操作功能是否易于被用戶認(rèn)知的要求Risk analysis reportComplianceUSABILITY VALIDATIONplan/ 可用性確認(rèn)計(jì)劃The MANUFACTURERS developed and maintains a USABILITY VALiDAT

25、iorplan specifying:制造商需制定并維護(hù)可用性確認(rèn)計(jì)劃，以規(guī)定：User ManualComplianceany method used forvalidations theusabilityof the PRIMARY OPERATING FUNCTIONS對(duì)于主要操作功能的可用性的確認(rèn)方法；User ManualCompliancethe criteria for determining successful VALIDATIONof theUSABILITYof the PRIMARY OPERATINGFUNCTiONSased on theusability SPEC

26、iFiCATiONand基于可用性規(guī)范，對(duì)主要操作功能可用性的確認(rèn)標(biāo)準(zhǔn)User ManualCompliancethe involvement of representative intendedUSERS包含的預(yù)期用戶代表User ManualComplianceUSABILITY VALiDATiONperformed in a laboratory setting 可用性確認(rèn)實(shí)施的實(shí)驗(yàn)室設(shè)置：Test report.Complianceusability VALiDATiONperformed in a simulated use environment 可用性確認(rèn)實(shí)施于模擬使用環(huán)境：T

27、est reportComplianceusability VALiDATiONperformed in the actual use environment 可用性確認(rèn)實(shí)施于真實(shí)使用環(huán)境：Test reportComplianceThe USABILITY VALiDATiorplan addresses：可用性確認(rèn)計(jì)劃包括：frequent Use Scenarios, and常見(jiàn)的使用情景；reasonably foreseeable worst caseuseSCENARIOS合理可預(yù)見(jiàn)的最壞使用情景that are identified in theusability specifi

28、cation都要在可用性規(guī)范中識(shí)別。User ManualComplianceThe USABILITY VALiDATiorplan recorded in the USABILITY ENGINEERING FILE可用性確認(rèn)計(jì)劃應(yīng)記錄與可用性工程文檔。User ManualComplianceUSER iNTERFACEesign and implementation/用戶界面設(shè)計(jì)和實(shí)施MANUFACTUREesigned and implemented theUSERinterfacbs described in theusabilitySPECiFiCATiONjtilizing,

29、as appropriate,usabilityENGiNEERiNmethods and techniques制造商應(yīng)使用可用性工程的方法和技術(shù)來(lái)開(kāi)發(fā)并實(shí)施 可用性規(guī)范描述的用尸界向。Products do not have this requirementnoncomplianceUSABILITY VERIFICATION/ 可用性驗(yàn)證MANUFACTUR verified the implementation of the MEdicalDEvice User INTERFACEesign according to the USABILITY SPECIFICATION制造商應(yīng)根據(jù)可用

30、性規(guī)范來(lái)驗(yàn)證醫(yī)療器械用戶界面設(shè) 計(jì)的實(shí)施。Products do not have this requirementnoncomplianceThe results of the verification are recorded in USABILITY ENGINEERING FILE驗(yàn)證的結(jié)果應(yīng)記錄于可用性工程文檔。Products do not have this requirementnoncomplianceUSABILITY VALIDATION 可用性確認(rèn)The MANUFACTURERS validated the Usability of themedicaldevice

31、according to theusability validationplan制造商應(yīng)根據(jù)可用性確認(rèn)計(jì)劃來(lái)確認(rèn)醫(yī)療器械用戶界 面的可用性。Products do not have this requirementnoncomplianceThe results are recorded in theusabilityENGINEERING FILE確認(rèn)的結(jié)果應(yīng)記錄于可用性工程文檔。Products do not have this requirementnoncomplianceFor the acceptance criteria documented in the usability V

32、ALiDATiorplan that are not met:對(duì)于沒(méi)后可用性確認(rèn)計(jì)劃中制定的未被滿足的接收準(zhǔn) 則：-further USERI NTERFACdesign andimplementation activities are performed; or需要進(jìn)行進(jìn)一步的用戶界面設(shè)計(jì)和執(zhí)行；或-if further improvement is not practicable, the MANUFACTURER may gather and review data and literature to determine if the medicalbenefits of the INT

33、ENDED USE outweigh the RISK arising from USABILITY problems如果進(jìn)一步的改進(jìn)不現(xiàn)實(shí)，制造商需要收集并評(píng)審數(shù) 據(jù)和文獻(xiàn)，以確定預(yù)期用途的醫(yī)療收益是否超過(guò)可用 性問(wèn)題帶來(lái)的風(fēng)險(xiǎn)。To perform this step, the MANUFACTURER needs to estimate the RISK arising from USABILITY problems.為此，制造商需評(píng)估可用性問(wèn)題帶來(lái)的風(fēng)險(xiǎn)。Products do not have this requirementnoncompliance6ACCOMPANYING DO

34、CUMENTS/文件The A CCOMPANYING DOCUMENTdes a summary of the Medical Device application specification隨機(jī)文件應(yīng)包括醫(yī)療器械應(yīng)用的規(guī)格的總結(jié)。User ManualComplianceA concise description of the MedicalDevice itsoperating principles, significant physical and performance characteristics and intended UserPROFiLEare included in the Accompanying documen隨機(jī)文件包括醫(yī)療器械、工作原理、重要的物理和性 能特性和預(yù)期用戶的特征的簡(jiǎn)要描述。User ManualTComplianceThe Accompanying DOCUMEwTtten at a level consistent with the intendedoperator profile隨機(jī)文件的編寫(xiě)要與用戶特征的水平相一致。User Manu