CE可用性工程評估報告EN精選

1、EN 62366:2008 Checklist/ 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 Referenee No/ 編號.Version/版本號:驗證人:Date of issue/ 發(fā)布日期：版本修改記錄:日期版本說明驗證人審批人4GENERAL REQUIREMENT要求4.1General Requirements/ 總要求4.1.1Usability ENgineerinGRoceSs可用性工程過程Has

2、the MANUFACTURERstablished,User Manu al;Complia ncdocume nted and maintained a usabilityeengineering process provide SAFETYforQuality manu al,the patient usERand others related toprocedure docume nt;usability for the product?制造商是否建立、記錄并維持了一個可用性工程過程，以確?；颊?、用戶和其它涉及產(chǎn)品適用性的人的安全？Does the P ROCESsaddress us

3、er iNTERActions with the medical DEVICEaccord ing to the accompanying DOCuMniclud ing, but not limited to tran sport, storage, in stallati on, operatio n, 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，如運輸、存儲、安裝、操作、 維護(hù)、維修和廢棄？User ManualComplia nce4.1.2Are Residualrisks associated withUs

4、ability of the medical Device presumed to be acceptable, uni ess there isobjectiveevidence。the con trary and docume nted?關(guān)系醫(yī)療器械可用性的剩余風(fēng)險是否推定可 接受？Risk an alysis report ;Complia nce4.1.3manufacturer SHAUbject the in formatio n for safety used as arisk controLo theUSABILITY ENGINEERING PROCE$e.g., warni

5、ngs or limitation of use in the accompanying DOCUMENTSk ing, etc.）.對于做為風(fēng)險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 Manu al;Complia nceDisregarding such information for safety is considered beyond any further reas on able means of risk control忽視安全信息的行為應(yīng)被認(rèn)為是超出風(fēng)險控 制措施的（即非正常使用）Risk an aly

6、sis reportComplia nce4.2The results of theusability engineeringPROCEsare recorded in theusabilityENGINEERING FILE可用性工程過程的結(jié)果記錄于可用性工程文 檔。Quality manu al, procedure docume nt;Complia nceThe records and other docume nts that make up the usability engineering file may form part of other docume nts and fi

7、les (e.g., a manufacturers product desig n file orrisk management fi),e(see List of docume 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 是其匕文檔(如技術(shù)文檔和風(fēng)險管理文檔) 的一部分Quality manu al, procedure docume ntComplia nce4.3Scali ng of theUsability ENGiNEERiNGffort/ 可用性工程的調(diào)整The USABILITY ENGINEERING PROCESSScaledb

8、ased on the sig nifica nee of anymodificati ons depe nding on the results of the risk ANALYSisa nd docume nted可用性工程調(diào)整取決于風(fēng)險分析確認(rèn)的設(shè)計更改的重要程度Risk an alysis reportComplia nce5USABILTY ENGINEERING PROC 可用性工程過程5.1Applicatio n specificati on/應(yīng)用的規(guī)格Applicatio n of Medical Device in theusability engineering fil

9、Es specified by the MANUFACTURaRd 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 (e.g., 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 ManualComplia nc e-intended patient population (e.g.,age, wei

10、ght, health, con diti on);User ManualComplia nc e預(yù)期患者群，如年齡、體重、健康和社會條件；-intended part of the body or type of tissue applied to or in teracted with;User ManualComplia nc e預(yù)期使用的身體部位或組織；-intended conditions of use (e.g.en vir onment in cludi ng hygie nic requireme nts, freque ncy of use, locati on, mobi

11、lity);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、地點和機(jī)動性；User ManualComplia nc e-operating principle(s)操作原理User ManualComplia nc e5.2Freque ntly used fun cti ons/常用功能Are freque ntly used functions that invoIve U SERinteraction with the MEDiCALDEViCEare determ ined and recorded in theusability engineering fil?User Ma

12、nualComplia nc e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？5.3Iden tificati on ofhazards nd HAZARDOUSiTUATiONgelated toUSABILITY識別可用性相關(guān)的危害和危害處境531Iden tificati on of characteristics tosafety 識別安全特征Identification of characteristicsrelated toSAFETY(part of ariskanalysis that focuses onusabilityperformed accord

13、ing to ISO 14971:2007, 4.2.應(yīng)按ISO 14971:2007, 4.2的要求識別專注于可用性的安全特征Risk an alysis reportComplia nc eDuring the identificationcharacteristics related toSAFETYthefollowi ng are con sidered:在識別安全特征時，要考慮下列因素：application specification,in clud inguserprofilES）； and應(yīng)用的規(guī)格，包括用戶特征；-frequently used functions.常用功能

14、。User ManualComplia nc eResults of this ide ntificati oncharacteristics related tosafetyrecorded in the usability engineering file安全特征識別的結(jié)果應(yīng)記錄于可用性工程文 檔User ManualComplia nc e532Iden tificati on of known or foreseeablehazards nd hazardousSITUATIONS識別已知的或可預(yù)見的危害和危害處境manufacturers ide ntified known or f

15、oreseeable HAZARDSpart of ariskanalysis related tousability accord ingto ISO 14971:2007, 4.3.制造商要按ISO 14971:2007, 4.3的要求識 別可用性相關(guān)的已知的或可預(yù)見的危害Riskan alysisreportComplia nc eIde ntificati on ofhazards on sideredHAZARDto patients USERnd otherpers ons識別危害時要考慮對患者、操作者和其他人員的危害Risk an alysis reportComplia nc

16、eReas on ably foreseeable seque nces or comb in ati ons of eve nts involving the userINTERFACE that can result in a HAZARDOUS SITUATION associated with the MEDICAL DEVICE were ide ntified. The SEVERITY of the resulti ng possible HARM is determi ned.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 別。導(dǎo)致的可能的危害的

17、嚴(yán)重程度已確定。Risk an alysis reportComplia nc eRisk an alysisreportUser ManualComplia nceDuri ng the ide ntificati on of HAZARDSand HAZARDOUS SITUATIONS, thefollowi ng was con sidered:在識別危害和危害處境時，下列需要考慮:application specification,in clud ing userrofilEs）；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

18、 text of use;使用的背景；-in formation on HAZARDS andHAZARDOUS SITUATIONS known forexist ing USER INTERFACES of MEDICALDEVICES of a similar type, ifavailable;對于現(xiàn)存的類似的醫(yī)療器械用戶界面的已知The results of this identification ofHAZARDS, HAZARDOUS SITUATIONS andSEVERITY are recorded in the USABILITY ENGINEERING FILE.識別危

19、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 nc e5.4Primary operating functiQ主要操作功能The manufacturer has determined the primary operating FUNCTION recorded in the USABILITY ENGINEERING FILEUser ManualComplia nc e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。The in puts to theprimary operatingFUNCTiONSnclud

20、e freque ntly usedfunctions and functions related toSAFETYOf the MEDICAL DEVICE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 ManualComplia nc e5.5Usability Specification 可用性規(guī)范manufacturEeveloped a usabilityQuality manu al,Complia ncSPECiFiCATiONrecorded in theusabilityprocedure docume nteENGINEERING FILES part

21、of theUSABILITYENGINEERING PROCESS制造商應(yīng)制疋可用性規(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。The usability sPECiFiCATiONrecorded inUSABILITY ENGINEERING FILEThe USABILITYSPECiFiCATiONmay be in tegrated intoother 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 nc eThe usability spe

22、cification ncludes:可用性規(guī)范包括：application specification;應(yīng)用的規(guī)格；PRIMARY OPERATING FUNCTIONS主要操作功能-HAZARDSnd H AZARDOUSlTUATIONSrelated to the U sability; and關(guān)系可用性的危害和危害處境-known or foreseeable use errors associated with the Medical Device已知的或可預(yù)見的關(guān)系醫(yī)療器械的使用錯 誤。User ManualRisk an alysisreportComplia nc eThe

23、usability sPECiFiCATiordescribes at least:可用性規(guī)范至少要描述：use scENARiocelated to theprimaryoperating FUNCTiqNSnclud ing關(guān)于主要操作功能的使用情景，包括：-frequent Use Seenarios, and常見的使用情景-reas on ably foreseeable worst caseUSE Scenarios合理可預(yù)見的最壞使用情景；User ManualRisk an alysisreportComplia ne e-UserI NTERFACEequirements fo

24、r the primary operating FUNCTi,Oncludi ng those to mitigate R isk;主要操作功能對于用戶界面的要求，包括降 低風(fēng)險的那些；Risk an alysis reportComplia nc e- Requirements for determining whether primary operating functions easily recog ni zable by the UserRisk an alysis reportComplia nc e用于決定主要操作功能是否易于被用戶認(rèn)知的要求5.6Usability valida

25、tion plan/ 可用性確認(rèn)計劃The MANUFACTURhas developed and mai ntains a usability VALiDATiorpla n specify ing:User ManualComplia nc e制造商需制定并維護(hù)可用性確認(rèn)計劃，以規(guī)疋：-any method used forVALiDATiONof theUSABILITYOf thePRIMARY OPERATING FUNCTQN對于主要操作功能的可用性的確認(rèn)方法；User ManualSComplia nc e-the criteria for determiningsuccessf

26、ul VALIDATIONof the USABILITY of the primary operating FUNCTiOased on the USABILITY SPECIFICATIONand基于可用性規(guī)范，對主要操作功能可用性的 確認(rèn)標(biāo)準(zhǔn)User ManualComplia nc e-the invoIvement of representative intended users包含的預(yù)期用戶代表User ManualComplia nc eusability VALiDATiorperformed in alaboratory sett ing可用性確認(rèn)實施的實驗室設(shè)置：Test

27、report.Complia nc eusability VALiDATiorperformed in asimulated use en vir onment可用性確認(rèn)實施于模擬使用環(huán)境：Test reportComplia nc eusability VALiDATiorperformed in the actual use en vir onment可用性確認(rèn)實施于真實使用環(huán)境：Test reportComplia nc eThe usability VALiDATiONpla n addresses:可用性確認(rèn)計劃包括：User ManualComplia ne e-frequent

28、Use Seenarios, and常見的使用情景；-reas on ably foreseeable worst easeUSE SCENARIOS合理可預(yù)見的最壞使用情景that are ide ntified in theusabilitySPECIFICATION都要在可用性規(guī)范中識別。The usability VALiDATiorpla n recorded inUser ManualComplia nethe USABILITY ENGINEERING FILEe可用性確認(rèn)計劃應(yīng)記錄與可用性工程文檔。5.7User iNTERFACdesig n and impleme ntat

29、io n/用戶界面設(shè)計和實施MNUFACTURdesig ned and impleme nted the usERiNTERFAcas described in the usabilityS PECIFICATIONutiliz ing, as appropriate, usability ENGiNEERiNmethods and tech niq ues制造商應(yīng)使用可用性工程的方法和技術(shù)來開 發(fā)并實施可用性規(guī)范描述的用戶界面。Products do not have this requireme ntnon- complia nc e5.8USABILITY VERIFICATION /

30、 可用性驗證MANUFACTUREerified the impleme ntati onProducts do notnon-of the M edical Device User iNTERFACdesignhave thiscomplia ncaccord ing to the usability specificationrequireme nte制造商應(yīng)根據(jù)可用性規(guī)范來驗證醫(yī)療器械用戶界面設(shè)計的實施。The results of the verification are recorded in usability engineering file驗證的結(jié)果應(yīng)記錄于可用性工程文檔。Pr

31、oducts do not have this requireme ntnon- complia nc e5.9Usability Validation 可用性確認(rèn)The MANUFACTURhas validated theUsability of the MEdical Device accord ing to the usability VALiDATiorpla n制造商應(yīng)根據(jù)可用性確認(rèn)計劃來確認(rèn)醫(yī)療器 械用戶界面的可用性。Products do not have this requireme ntnon- complia nc eThe results are recorded in

32、 the usability engineering 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 nc eFor the accepta nee criteria docume nted in the usability VALiDATiorpla n that are not met:對于沒有可用性確認(rèn)計劃中制定的未被滿足 的接收準(zhǔn)則：-further U ser I NTERFACdesign and impleme ntati on activities areperformed; or需

33、要進(jìn)行進(jìn)一步的用戶界面設(shè)計和執(zhí)行；或-if further improveme nt is not practicable, the MANUFACTURER may gather and review data and literature to determ ine if the medical ben efits of the INTENDED USE outweigh the RISK aris ing from USABILITY problems如果進(jìn)一步的改進(jìn)不現(xiàn)實，制造商需要收集 并評審數(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。To perform t

34、his step, the MANUFACTURER n eeds to estimate the RISK aris ingProducts do nothave thisrequireme ntnon-complia nce6ACCOMPANYING DOCUMENTSThe Accompanying DOCuMnNludes aUser ManualComplia ncsummary of the M edical Device applicationespecificatio n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)。A con cise descriptio n of the Med

35、icalUser ManualComplia ncDevice its operati ng prin ciples,esig ni fica nt physical and performa neecharacteristics and inten ded UserPROFiLEare in cluded in the AccompanyingDOCUMENT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。The Accompanying DOCuMENwritte n at a level consistent with the intended OPERATOR PROFILE隨機(jī)文件的編寫要與用戶特征的水平相一 致。User ManualComplia nceThe Accompanyi