ce_可用性工程評估報(bào)告en62366

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(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 REQUIREMENTS/總要求4.1General Requirements/總要求4.1.1Usability Engineering Process/可用性工程過程

2、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(gè)可用性工程過程，以確?；颊摺⒂脩艉推渌婕爱a(chǎn)品適用性的人的安全?User Manual;Quality manual, procedure document;ComplianceDoes the Proces

3、s 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(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 ManualCompliance4.1.2Are Residual Risks associate

4、d 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(xiǎn)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 pro

5、cess (e.g., warnings or limitation of use in the accompanying documents, marking, etc.).對于做為風(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 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(rèn)為是超出風(fēng)險(xiǎn)控制措施的（即非正常

6、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 doc

7、uments 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(xiǎn)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 proc

8、ess 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(xiǎn)分析確認(rèn)的設(shè)計(jì)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 engi

9、neering 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(hù)、治療、診斷或預(yù)防的狀態(tài)或疾??；User ManualCompliance intended patient population (e.g., a

10、ge, weight, health, condition);預(yù)期患者群，如年齡、體重、健康和社會(huì)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(diǎn)和機(jī)動(dòng)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了涉及

12、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(shí)別可用性相關(guān)的危害和危害處境5.3.1Identification of characteristics to safety/識(shí)別安全特征Identification of characteristics related to safety (part of a risk analysis) that focuses on usability performed accor

13、ding to ISO 14971:2007, 4.2.應(yīng)按ISO 14971:2007, 4.2的要求識(shí)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(shí)別安全特征時(shí)，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 functions.

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

15、wn 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(shí)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(shí)別危害時(shí)要考慮對患者、操作者和其他人員的危害Risk analysis

16、 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(shí)別。導(dǎo)致的

17、可能的危害的嚴(yán)重程度已確定。Risk analysis report ComplianceDuring the identification of HAZARDS and HAZARDOUS SITUATIONS, the following was considered:在識(shí)別危害和危害處境時(shí)，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 HAZAR

18、DS 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(cuò)誤； if an incorrect mental model of the operation of the MEDICAL DEVICE can cause a USE ERROR r

19、esulting in a HAZARDOUS SITUATION; and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 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(shí)別危害、危害處

20、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 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 includ

21、e 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)manufacturer developed a usability specification recorded in the usability engineering file as part of the usability engineering process制造商

22、應(yīng)制定可用性規(guī)，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)記錄于可用性工程文檔里?？捎眯砸?guī)可以整合于其它規(guī)。Quality manual, procedure documentComplianceThe usabili

23、ty specification includes: 可用性規(guī)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(cuò)誤。User ManualRisk analysis report Comp

24、lianceThe usability specification describes at least:可用性規(guī)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 User Inte

25、rface 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(xiǎn)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(rèn)知的要求Risk analysis report Complianc

26、e5.6Usability validation plan/可用性確認(rèn)計(jì)劃The manufacturer has developed and maintains a usability validation plan 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 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(rèn)方法；User ManualCompliance the criteria

27、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)，對主要操作功能可用性的確認(rèn)標(biāo)準(zhǔn)User ManualCompliance the involvement of representative intended users 包含的預(yù)期用戶代表User ManualComplianceusability validation performed in a laboratory

28、 setting:可用性確認(rèn)實(shí)施的實(shí)驗(yàn)室設(shè)置：Test report.Complianceusability validation performed in a simulated use environment:可用性確認(rèn)實(shí)施于模擬使用環(huán)境：Test reportComplianceusability validation performed 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 validation plan addresses: 可用性確認(rèn)計(jì)劃包括： frequent

29、 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)中識(shí)別。User ManualComplianceThe usability validation plan 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 ManualCompliance5.7User interface d

30、esign and implementation/用戶界面設(shè)計(jì)和實(shí)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(shí)施可用性規(guī)描述的用戶界面。Products do not have this requirementnon-compliance5.8Usabi

31、lity verification /可用性驗(yàn)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)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 requirementnon-complianceThe results of the verification are recorded in usability engineering fil

32、e驗(yàn)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(rèn)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(rèn)計(jì)劃來確認(rèn)醫(yī)療器械用戶界面的可用性。Products do not have this requirementnon-complianceThe results a

33、re 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 requirementnon-complianceFor the acceptance criteria documented in the usability validation plan that are not met:對于沒有可用性確認(rèn)計(jì)劃中制定的未被滿足的接收準(zhǔn)則：- further User Interface design and implementation activities are perform

34、ed; 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 medical benefits of the INTENDED 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

35、 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(xiǎn)。Products do not have this requirementnon-compliance6ACCOMPANYING DOCUMENTS/隨機(jī)文件The Accompanying document includes 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)。U

36、ser 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(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 Accompanying 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。Us