CE-可用性工程評價報告EN62366

1、EN 62366:2022 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 Reference 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 REQUIREMENTS/ 總要求General Requirements/ 總要求ENGINEERING PROCESS/可用性工程過程Has the manufa

2、cturer established, documented and maintained a usability engineering process to provide safety for the patient , user and others related to 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,以保證患者、用戶和其它涉及產(chǎn)品適用性的人的 平安User Manual;Quality manual, procedure document;ComplianceDoes the P ROCESS address us

3、er intera ctions with the MEDICAL DEVICE according to the accompanying document including, but not limited to transport, storage, installation, operation, maintenance, 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 ManualComplianceresidual RISKS associated with usability of

4、 the medical device presumed to be acceptable, unless there is objective evidence to the contrary and documented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 analysis report ;Compliancemanufacturer shall subject the information for safety used as a RISK control to the usability engineering PROCESS ., warnings or limit

5、ation of use in the accompanying documents , marking, etc.對于做為風(fēng)險限制舉措的平安信息,制造商應(yīng)把它納 入可用性工程過程的限制Risk analysis report ;User Manual;ComplianceDisregarding such information for safety is considered beyond any further reasonable means of RISK CONTROL無視平安信息的行為應(yīng)被認(rèn)為是超出風(fēng)險限制舉措的 即非正常使用Risk analysis reportComplia

6、nceThe results of the usability engineering process are recorded in the usability engineering file可用性工程過程的結(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 MAY form part of other documents and files ., a manufacturer

7、 S product design file or risk management file ),(SEE List 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)險治理文檔)的一局部Quality manual, procedure documentComplianceScaling of the usability engineering effort/ 可用性工程的調(diào)整The USABILITY engineering process is scaled based on the significanc

8、e of any modifications depending on the results of the RISK analysis and documented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 analysis reportCompliance5USABILTY ENGINEERING PROCESS/可用性工程過程Application specification/ 應(yīng)用的規(guī)格Application of M edical device in the usability engineering file is specified by the MANUFA

9、CTURER and 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) 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?。籙ser ManualComplianceintended patient population ., age, weight, health, condition);預(yù)期患者群,如年齡、體重、健康和

10、社會條件；User ManualComplianceintended part of the body or type of tissue applied to or interacted 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、 地點和機(jī)動性；User ManualComplian

11、ceoperating principle(s)操作原理User ManualComplianceFrequently used functions/常用功能Are frequently used functions that involve USERinteraction with the M edical d evice are determined and recorded in the usability engineering 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 of h

12、azards and hazardous situations related to usability/識別可 用性相關(guān)的危害和危害處境of characteristics tosafety / 識別平安特征Identification of characteristics related tosafety(part of a RISK analysis ) that focuses on usability performed according to ISO 14971:2022,.應(yīng)按ISO 14971:2022,的要求識別專注十可用性的安 全特征Risk analysis repor

13、tComplianceDuring the identification characteristics related to safety , the following are considered:在識別平安特征時,要考慮以下因素：application specification, includinguserprofile (S); 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 to sa

14、fety recorded in the usability engineering file平安特征識別的結(jié)果應(yīng)記錄于可用性工程文檔User ManualComplianceof known or foreseeable hazards and hazardous situations /識另ij 的或可預(yù) 見的危害和危害處境manufacturer has identified known or foreseeable HAZARDS (part of a RISK ANALYSIS ) related to USABILITY according to ISO 14971:2022,.制

15、造尚要按ISO 14971:2022, 的要求識別可用性相關(guān) 的的或可預(yù)見的危害Risk analysis reportComplianceIdentification of hazards considered hazards to patients , users and other persons識別危害時要考慮對患者、操作者和其他人員的危害Risk analysis reportComplianceReasonably foreseeable sequences or combinations of events involving theUSERinterface that can

16、result in a hazardous situation associated with the medical device were identified. The severity of the resulting possible harm is determined.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 能的危害的嚴(yán)重程度已確定.Risk analysis reportComplianceDuring the identification of hazards and hazardous situations , the f

17、ollowing was considered: 在識別危害和危害處境時,以下需要考慮：application specification, includinguser rofile (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；information on hazards and hazardoussituations known for existing user interfaces of medical devices of a similar type, if available;對于現(xiàn)

18、存的類似的醫(yī)療器械用戶界面的的危害和危害處境信息；preliminary USE SCENARIOS ;初步的使用情景；possible USE ERRORS;可能的使用錯誤；if an incorrect mental model of the operation of the MEDICAL DEVICE can cause a use error resulting in a hazardous situation ; and操作醫(yī)療器械的錯誤精神模型是否會引起導(dǎo)致危害處境的使用錯誤；results of the review of the user interface 用戶界面的評審結(jié)

19、果.Risk analysis reportUser ManualComplianceThe results of this identification ofhazards ,hazardous situations and severity are recorded in the usability engineering file .識別危害、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 analysis reportComplianceP RIMARY OPERATING FUNCTIONS /主要操作功能The manufacturer has determined

20、the primary operating FUNCTIONS and recorded in the usability 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 ManualComplianceThe inputs to the primary operating functions include frequently used functions and functions related to safety of 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 Manual

21、ComplianceU SABILITY SPECIFICATION /可用性標(biāo)準(zhǔn)manufacturer developed a usability specification recorded in the usability engineering file as part of the USABILITY ENGINEERING PROCESS制造商應(yīng)制定可用性標(biāo)準(zhǔn),記錄于可用性工程文檔里作為可用性工程過程的一局部.Quality manual, procedure documentComplianceThe usability specification recorded in us

22、ability ENGINEERING FILE . The USABILITY SPECIFICATION may be integrated into other specifications可用性標(biāo)準(zhǔn)記錄于可用性工程文檔里.可用性標(biāo)準(zhǔn) 可以整合于其它標(biāo)準(zhǔn).Quality manual, procedure documentComplianceThe USABILITY specification includes:可用性標(biāo)準(zhǔn)包括：application specification;應(yīng)用的規(guī)格；PRIMARY OPERATING FUNCTIONS主要操作功能HAZARDS and H a

23、zardous situations related 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 M edical Device的或可預(yù)見的關(guān)系醫(yī)療器械的使用錯誤.User ManualRisk analysis reportComplianceThe usability specification describes at least:可用性標(biāo)準(zhǔn)至少要描述：use scenarios related to the primary operating functi

24、ons , including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reasonably foreseeable worst caseU SE SCENARIOS;合理可預(yù)見的最壞使用情景；User ManualRisk analysis reportComplianceU SER INTERFACE requirements for the PRIMARY OPERATING FUNCTIONS , including those to mitigate RISK;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

25、analysis reportComplianceRequirements for determining whetherprimaryoperating functions are 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 reportComplianceU SABILITY VALIDATION plan/ 可用性確認(rèn)方案The manufacturer has developed and maintains a USABILITY VALIDATION plan specifying:制造商需制

26、定并維護(hù)可用性確認(rèn)方案,以規(guī)定：User ManualComplianceany method used for validation of the usability of the PRIMARY OPERATING FUNCTIONS ;對于主要操作功能的可用性確實認(rèn)方法；User ManualCompliancethe criteria for determining successfulvalidationof the usability of the PRIMARY operating functions based on the usability specification ;

27、and基于可用性標(biāo)準(zhǔn),對主要操作功能可用性確實認(rèn)標(biāo)準(zhǔn)User ManualCompliancethe involvement of representative intendedusers包含的預(yù)期用戶代表User ManualComplianceusability validation performed in a laboratory setting 可用性確認(rèn)實施的實驗室設(shè)置：Test report.Complianceusability validation performed in a simulated use environment可用性確認(rèn)實施于模擬使用環(huán)境：Test repo

28、rtComplianceusability validation performed in the actual use environment可用性確認(rèn)實施于真實使用環(huán)境：Test reportComplianceThe USABILITY validation plan addresses:可用性確認(rèn)方案包括：frequent Use Scenarios, and常見的使用情景；reasonably foreseeable worst caseuse scenarios合理可預(yù)見的最壞使用情景that are identified in the usability specificatio

29、n都要在可用性標(biāo)準(zhǔn)中識別.User ManualComplianceThe USABILITY validation plan recorded in the USABILITY ENGINEERING FILE可用性確認(rèn)方案應(yīng)記錄與可用性工程文檔.User ManualComplianceUSER interface design and implementation/用戶界面設(shè)計和實施manufacturer designed and implemented the user interface as described in the usability specification uti

30、lizing, as appropriate, usability engineering methods and techniques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 可用性標(biāo)準(zhǔn)描述的用尸界向.Products do not have this requirementnoncomplianceU SABILITY VERIFICATION /可用性驗證Manufacturer verified the implementation of the M edical device user interface design according to the USABILITY SP

31、ECIFICATION制造商應(yīng)根據(jù)可用性標(biāo)準(zhǔn)來驗證醫(yī)療器械用戶界面設(shè) 計的實施.Products do not have this requirementnoncomplianceThe 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.Products do not have this requirementnoncomplianceU SABILITY VALIDATION/可用性確認(rèn)The manufacturer has validated the U sabil

32、ity of the medical device according to the usability VALIDATION plan制造商應(yīng)根據(jù)可用性確認(rèn)方案來確認(rèn)醫(yī)療器械用戶界 面的可用性.Products do not have this requirementnoncomplianceThe results are recorded in 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 requirementnoncomplianceFor the acceptance criteria

33、 documented in the USABILITY VALIDATION plan that are not met:對于沒后可用性確認(rèn)方案中制定的未被滿足的接收準(zhǔn) 那么：-further U ser interface design and implementation activities are performed; or需要進(jìn)行進(jìn)一步的用戶界面設(shè)計和執(zhí)行；或-if further improvement is not practicable, the MANUFACTURER may gather and review data and literature to determi

34、ne if the medical benefits of the INTENDED USE outweigh the RISK arising from USABILITY problems如果進(jìn)一步的改良不現(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 this step, the MANUFACTURER needs to estimate the RISK arising from USABILITY problems.為此,制造商需評估可用性問題帶來的風(fēng)險.Products do not have this req

35、uirementnoncompliance6ACCOMPANYING DOCUMENTS/隨機(jī)文件The A ccompanying document includes a summary of the M edical 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 M edical device , its operating principles, significant physical and performance characteristics and intended UserP ROFILE are included in the A CCOMPANYING DOCUMENT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 ManualComplianceThe A CCOMPANYING document is written 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 ManualComplian