EN62366_2008 醫(yī)療器械可用性工程評估報告

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 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歡迎下載4GENERAL REQUIREMENTS/總要求4.1General Requirements/總要求4.1.1Usability Engineering Process/可用性工

2、程過程Has the manufacturer 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 Pro

3、cess address user interactions 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文件與醫(yī)療器械的交互，如運輸、存儲、安裝、操作、維護、維修和廢棄？User ManualCompliance4.1.2Are Residual Risks associ

4、ated with Usability of 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 ;Compliance4.1.3manufacturer shall subject the information for safety used as a risk control to the usability engineering

5、process (e.g., warnings or limitation of use in the accompanying documents, marking, 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 analysis report ;User Manual;ComplianceDisregarding such information for safety is considered beyond any further reasonable means of risk control忽視安全信息的行為應(yīng)被認為是超出風(fēng)險控制措施的（即

6、非正常使用）Risk analysis report Compliance4.2The 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

7、documents and files (e.g., a manufacturers 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)險管理文檔）的一部分Quality manual, procedure documentCompliance4.3Scaling of the Usability Engineering effort/可用性工程的調(diào)整The usability engineering p

8、rocess is scaled based on the significance 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)險分析確認的設(shè)計更改的重要程度Risk analysis report Compliance5USABILTY ENGINEERING PROCESS/可用性工程過程5.1Application specification/應(yīng)用的規(guī)格Application of Medical Device in the usability e

9、ngineering file is specified by the manufacturer 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 (e.g., 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、治療、診斷或預(yù)防的狀態(tài)或疾??；User ManualCompliance intended patient population (e.g.

10、, age, weight, health, condition);預(yù)期患者群，如年齡、體重、健康和社會條件；User ManualCompliance intended 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 ManualCompliance intended conditions of use (e.g. environment including hygienic requirements, frequency of use, location, mobility

11、); 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、地點和機動性；User ManualCompliance operating principle(s)操作原理User ManualCompliance5.2Frequently used functions/常用功能Are frequently used functions that involve User interaction with the Medical Device 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

12、了涉及用戶與醫(yī)療器械交互的常用功能？User ManualCompliance5.3Identification of hazards and hazardous situations related to usability/識別可用性相關(guān)的危害和危害處境5.3.1Identification of characteristics to safety/識別安全特征Identification of characteristics related to safety (part of a risk analysis) that focuses on usability performed ac

13、cording 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 analysis report ComplianceDuring the identification characteristics related to safety, the following are considered:在識別安全特征時，要考慮下列因素： application specification, including user profile(s); and應(yīng)用的規(guī)格，包括用戶特征；frequently used functio

14、ns.常用功能。User ManualComplianceResults of this identification characteristics related to safety recorded 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 ManualCompliance5.3.2Identification of known or foreseeable hazards and hazardous situations/識別已知的或可預(yù)見的危害和危害處境manufacturer has identified

15、known or foreseeable hazards (part of a risk analysis) related to usability according to 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Risk analysis report ComplianceIdentification 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 analy

16、sis report ComplianceReasonably foreseeable sequences or combinations of events involving the user INTERFACE that can 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。

17、導(dǎo)致的可能的危害的嚴重程度已確定。Risk analysis report ComplianceDuring the identification of HAZARDS and HAZARDOUS SITUATIONS, the following was considered:在識別危害和危害處境時，下列需要考慮： application specification, including user 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 HA

18、ZARDS and HAZARDOUS SITUATIONS known for existing USER INTERFACES of MEDICAL DEVICES of a similar type, if available;對于現(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； 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 ERRO

19、R 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)果。Risk analysis report User ManualComplianceThe results of this identification of HAZARDS, HAZARDOUS SITUATIONS and SEVERITY are recorded in the USABILITY ENGINEERING FILE.識別危害、

20、危害處境和嚴重程度的結(jié)果要記錄在可用性工程文檔里。Risk analysis report Compliance5.4Primary operating functions/主要操作功能The manufacturer has determined 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 inc

21、lude 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 ManualCompliance5.5Usability Specification/可用性規(guī)范manufacturer developed a usability specification recorded in the usability engineering file as part of the usability engineering proces

22、s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 manual, procedure documentComplianceThe usability specification recorded in usability engineering file. The usability specification may 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。Quality manual, procedure documentComplianceThe

23、 usability specification includes: 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 hazards and Hazardous Situations related to the Usability; 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 analysis re

24、port ComplianceThe usability specification describes at least:可用性規(guī)范至少要描述： use scenarios related to the primary operating functions, 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 case Use Scenarios; 合理可預(yù)見的最壞使用情景；User ManualRisk analysis report Compliance

25、 User 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 analysis report Compliance Requirements for determining whether primary operating 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知的要求Risk analysis report

26、 Compliance5.6Usability validation plan/可用性確認計劃The manufacturer has developed and maintains a usability validation plan specifying:制造商需制定并維護可用性確認計劃，以規(guī)定：User ManualCompliance any method used for validation of the usability of the primary operating functions;對于主要操作功能的可用性的確認方法；User ManualCompliance the

27、 criteria for determining successful validation of the usability of the primary operating functions based on the usability specification; and基于可用性規(guī)范，對主要操作功能可用性的確認標準User ManualCompliance the involvement of representative intended users 包含的預(yù)期用戶代表User ManualComplianceusability validation performed in a

28、 laboratory setting:可用性確認實施的實驗室設(shè)置：Test report.Complianceusability validation performed in a simulated use environment:可用性確認實施于模擬使用環(huán)境：Test reportComplianceusability validation performed in the actual use environment:可用性確認實施于真實使用環(huán)境：Test reportComplianceThe usability validation plan addresses: 可用性確認計劃包

29、括： frequent Use Scenarios, and常見的使用情景； reasonably foreseeable worst case use scenarios合理可預(yù)見的最壞使用情景that are identified in the usability specification都要在可用性規(guī)范中識別。User ManualComplianceThe usability validation plan recorded in the usability engineering file可用性確認計劃應(yīng)記錄與可用性工程文檔。User ManualCompliance5.7User

30、 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 utilizing, 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)并實施可用性規(guī)范描述的用戶界面。Products do not have this requirementnon-compl

31、iance5.8Usability verification /可用性驗證Manufacturer verified the implementation of the Medical Device User interface design according to the usability specification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。Products do not have this requirementnon-complianceThe results of the verification are recorded in usability e

32、ngineering file驗證的結(jié)果應(yīng)記錄于可用性工程文檔。Products do not have this requirementnon-compliance5.9Usability Validation/可用性確認The manufacturer has validated the Usability of the Medical Device according to the usability validation plan制造商應(yīng)根據(jù)可用性確認計劃來確認醫(yī)療器械用戶界面的可用性。Products do not have this requirementnon-complianc

33、eThe results are recorded in the usability engineering file確認的結(jié)果應(yīng)記錄于可用性工程文檔。Products do not have this requirementnon-complianceFor the acceptance criteria documented in the usability validation plan that are not met:對于沒有可用性確認計劃中制定的未被滿足的接收準則：- further User Interface design and implementation activiti

34、es are performed; or需要進行進一步的用戶界面設(shè)計和執(zhí)行；或- if further improvement is not practicable, the MANUFACTURER may gather and review data and literature to determine if the medical benefits of the INTENDED USE outweigh the RISK arising from USABILITY problems如果進一步的改進不現(xiàn)實，制造商需要收集并評審數(shù)據(jù)和文獻，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

35、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 requirementnon-compliance6ACCOMPANYING DOCUMENTS/隨機文件The Accompanying document includes a summary of the Medical Device application specification隨機文件應(yīng)包括

36、醫(yī)療器械應(yīng)用的規(guī)格的總結(jié)。User ManualComplianceA concise description of the Medical Device, its operating principles, significant physical and performance characteristics and intended User Profile are included in the Accompanying document隨機文件包括醫(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 Accompanying document is written at a level consistent with the intended operator profile隨機文件的編寫要與用戶特征的水平相一致。