CE可用性工程評(píng)估報(bào)告EN

1、E N 62366:2008 Checkl 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 Refere nee 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：日期版本說明驗(yàn)證人審批人4GENERAL REQUIREMENT總要求Gen eral Requireme nts/總要求ENGINEERINPROCES呵 用性工程過程Has the MANUFAC

2、TURERtablished, 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、記錄并維持了一個(gè)可用性工程過 程，以確保患者、用戶和其它涉及產(chǎn)品適用性的人的 安全User Man ual;Quality man ual, procedure docume nt;Complia neeDoes the P ROCESSiddress USER iNTERA

3、tions with the medical DEViCEccording to theaccompanyingDOCUMENTcluding, but not limited totransport, storage, installation, operation, maintenan ce, repair and disposal該過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 Man ualComplia neeRESIDUALRISKS associated withUSABILITY of themedicaldevice

4、presumed to be acceptable, unl ess there is objective evidence the con trary and docume nted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 an alysis report ;Complia neemanufacturer SHALLbject the in formation for safety used as arisk controLd the usabilityengineering PROCESSvarnings or limitation of use in the accompan

5、ying docum EiNTki ng, 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忽視安全信息的行為應(yīng)被認(rèn)為是超岀風(fēng)險(xiǎn)控制措施的 （即非正常使用）Risk an alysis reportComplia neeThe results of theu

6、sability ENGiNEERiNGROCEsarerecorded in theusability engineering file可用性工程過程的結(jié)果記錄于可用性工程文檔。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 m

7、anagement F)i,le(SEEList of documents 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 man ual, procedure docume ntComplia neeScali ng of theusability ENGINEERINGffort/可用性工程的調(diào)整The usability engineering PROCESScaled based onthe sig nifica nee of any modificati onsdepe nding on t

8、he results of therisk ANALYSiSa nddocume 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 an alysis reportComplia nee5USABILTY ENGINEERING PROCES可用 性工程過程Applicati on specificati on/應(yīng)用的規(guī)格Applicatio n of MEDiCALDEViCEi n theusabilityengineering file, specified by themanufacturerand in cludes可用性工程文檔中的醫(yī)療器械的應(yīng)用由制造商決 定

9、，包括：-intended medical indication .,con diti on s(s) or disease(s) to be scree ned, mon itored, treated, diag no sed, or preve nted);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??；User Man ualComplia nee-intendedPATiENTpopulation ., age, weight,health, con diti on);預(yù)期患者群，如年齡、體重、健康和社會(huì)條件；User Man ualComplia nee-inte

10、nded part of the body or type of tissue applied to or in teracted with;預(yù)期使用的身體部位或組織；User Man ualComplia nee-intended conditions of use . environment in cludi ng hygie nic requireme nts, freque ncy of use, locati on, 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 Man ualComplia neeoperating princip

11、le(s)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 Man ualComplia neeIdentification ofHAZARDahd HAZ

12、ARDOUSSTUATIONSelated tousability 識(shí)別可用性相關(guān)的危害和危害處境of characteristics tosafety 識(shí)別安全特征Identification of characteristics related toSAFETpart of arisk ANALYSiSthat focuses onUSABiLiTYperformed accord ing to ISO 14971:2007,.應(yīng)按ISO 14971:2007,的要求識(shí)別專注于可用性的安全特征Risk an alysis reportComplia neeDuring the identi

13、fication characteristics related toSAFETYthe followi ng are con sidered:在識(shí)別安全特征時(shí)，要考慮下列因素：applicati on specificati on, in clud inguserPROFILES); and應(yīng)用的規(guī)格，包括用戶特征；-frequently used functions.常用功能。User Man ualComplia neeResults of this identification characteristics related toSAFETYecorded in theusabilit

14、yENGINEERING 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 Man ualComplia neeof known or foreseeableHAZARDSnd hazardousituations識(shí)別已知的或可預(yù)見的危害和危害處境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,的要求識(shí)別可用性相關(guān) 的已知的或可預(yù)見的危害Risk

15、 an alysis reportComplia neeIde ntificati on ofhazardo nsideredhazardpatients USERS3nd other persons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 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 w

16、ith themedical DEVICEvereiden tified. TheSEVERiTYof the resulti ngpossibleHARMis determ in ed.包括可能導(dǎo)致危害處境的醫(yī)療器械用戶界面的合理 可預(yù)見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 an alysis reportComplia neeDuri ng the ide ntification ofHAZARDS! ndhazardous SiTUATQiNSe follow ing was con sidered:在識(shí)別危害和危害處境時(shí)，下列需要考慮：applic

17、ati on specificati on, in clud inguserrofilE s)；應(yīng)用的規(guī)格，包括用戶特征；task related requireme nts;任務(wù)相關(guān)的要求；-con text of use;使用的背景；-information onhazards!nd hazardous situationknown for existinguser iNTERFACE(Sf 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；-prelim in aryuse scena

18、rios初步的使用情景；possible use errors；可能的使用錯(cuò)誤；if an in correct men tal model of the operati on of themedical devices n cause a useERROResult ing in ahazardous SiTUATipNid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 an alysis reportUser Man ual、Complia neeThe res

19、ults of this ide ntificatio n ofhazardshazardous siTUATiONSid 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。Risk an alysis reportComplia neePrimary operating function要 操作功能The man ufacturer has determ ined theprimaryoperating functionsi recorded in theusability

20、ENGINEERING 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 Man ualComplia neeThe in puts to theprimary operating functionsin clude freque ntly used fun cti ons and fun cti ons related toSAFETYof the MEDICALCEVICE主要操作功能的輸入包括常用功能和關(guān)系醫(yī)療器械安 全的功能。User Man ualComplia neeUSABILITY SPECIFICATION 可用性規(guī)范MANUFACTURdevelop

21、ed 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程的一部分。Quality man ual, procedure docume ntComplia neeThe usability SPECiFiCATiONecorded in usability ENGINEERING FILEThe USABILITY SPECIFICATIOmay be in teg

22、rated into other specificati ons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。Qualitymanu al,procedure docume ntComplia neeThe USABILITY SPECIFICATIONicludes：可用性規(guī)范包括：applicati on specificati on;應(yīng)用的規(guī)格；-PRIMARY OPERATING FUNCTIONS主要操作功能-HAZARDS!nd H AZARDOUSlTUATIONSelated to the Usability; and關(guān)系可用性的危害和危害處境-known

23、or foreseeableuse ERROfOSsociatedwith the M edicalcevice已知的或可預(yù)見的關(guān)系醫(yī)療器械的使用錯(cuò)誤。User Ma nualRisk an alysis reportComplia neeThe USABILITY SPECiFiCATiONescribes at least:可用性規(guī)范至少要描述：-use scENARiorelated to theprimary operatingFUNCTiONSi ncludi ng關(guān)于主要操作功能的使用情景，包括：-frequent Use Scenarios, and常見的使用情景-reas on

24、 ably foreseeable worst caseUSE SCENARIOS合理可預(yù)見的最壞使用情景；User Ma nualRisk an alysis reportComplia nee-U SERI NTERFACBequirements for theprimaryoperating FUNCTioinclud ing those to mitigate RISK;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 an alysis reportComplia nee-Requirements for determining whetherprimaryoperat

25、ing FUNCTIONS easily recog nizable by theUSER用于決定主要操作功能是否易于被用戶認(rèn)知的要求Risk an alysis reportComplia neeUSABILITY VALIDATIONplan/ 可用性確認(rèn)計(jì)劃The MANUFACTURERS developed and maintains aUSABILITY VALIDATION）。n 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 Ma nualComplia neeany method used forvalidations theusabilityof

26、the PRIMARY OPERATING FUNCTIONS對(duì)于主要操作功能的可用性的確認(rèn)方法；User Ma nualComplia neethe criteria for determining successfulVALIDATIONof theUSABILITY of the PRIMARY OPERATINGFUNCTiONSased on theusability specifications nd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 Ma nualComplia nee-the involvement of representative intendedUSE

27、RS包含的預(yù)期用戶代表User Ma nualComplia neeusability VALiDATiorperformed in a laboratorysett ing 可用性確認(rèn)實(shí)施的實(shí)驗(yàn)室設(shè)置：Test report.Complia neeusability VALiDATiONperformed in a simulated use environment 可用性確認(rèn)實(shí)施于模擬使用環(huán)境：Test reportComplia neeusability VALiDATiorperformed in the actual use environment 可用性確認(rèn)實(shí)施于真實(shí)使用環(huán)境：Te

28、st reportComplia neeThe USABILITY VALiDATiorplan addresses:可用性確認(rèn)計(jì)劃包括：-frequent Use Scenarios, and常見的使用情景；-reas on ably foreseeable worst caseuseSCENARIOS合理可預(yù)見的最壞使用情景that are ide ntified in theusability specification都要在可用性規(guī)范中識(shí)別。User Ma nualComplia neeThe USABILITY VALiDATiOfplan recorded in the USABI

29、LITY ENGINEERING FILE可用性確認(rèn)計(jì)劃應(yīng)記錄與可用性工程文檔。User Ma nualComplia neeUSER iNTERFACdesig n and impleme ntati on/用戶界面設(shè)計(jì)和實(shí)施MANUFACTURfiRsig ned and impleme nted theuseriNTERFACBs described in theusabilitySPECiFiCATiONlJtilizi ng, as appropriate,USABILITYENGiNEERiNGiethods and tech ni ques制造商應(yīng)使用可用性工程的方法和技術(shù)來開發(fā)

30、并實(shí)施 可用性規(guī)范描述的用戶界面。Products do not have this requireme ntnon- complia neeUSABILITY VERIFICATION/ 可用性驗(yàn)證MANUFACTUR VRrified the impleme ntati on of the MEdicalDEvice User iNTERFACEesig n accord ing to the USABILITY SPECIFICATION制造商應(yīng)根據(jù)可用性規(guī)范來驗(yàn)證醫(yī)療器械用戶界面設(shè) 計(jì)的實(shí)施。Products do not have this requireme ntnon- comp

31、lia neeThe 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 requireme ntnon-complia neeUSABILITY VALIDATION 可用性確認(rèn)The MANUFACTURERS validated the Usability of themedicaldevice accordi ng to theusability validationpla n制造商應(yīng)根據(jù)可用性確認(rèn)計(jì)劃來確認(rèn)醫(yī)療器

32、械用戶界 面的可用性。Products do not have this requireme ntnon-complia neeThe 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 requireme ntnon-complia neeFor the acceptanee criteria documented in the usability VALiDATiorpla n that are not met:對(duì)于沒有可用性確認(rèn)計(jì)劃中制定的未被滿足的接

33、收準(zhǔn) 則：-further U SER 1 NTERFACEesign and impleme ntati on 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 medicalben efits of the INTENDED USE outweigh the RISK aris ing from USA

34、BILITY 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)療收益是否超過可用 性問題帶來的風(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)估可用性問題帶來的風(fēng)險(xiǎn)。Products do not have this requireme ntnon-complia nee6ACCOMPANYING DOCUMENTS/ 文件The A CCOMPANYING DOCUiMENTdes

35、 a summary of the Medical Device applicati on specificati on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 Man ualComplia neeA con cise descripti on 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)期用戶的特征的簡要描述。User Man ualTComplia neeThe Accompanying DOCUiMEWTtte n at a levelcon siste nt with the inten dedoperator profile隨機(jī)文件的編寫要與用戶特征的水平相一致。User Man ualComplia nee