ce-可用性工程評估報告en62366(已修改)
2025-05-25 18:20 本頁面
【正文】 Page 2 of 13 Report No. 錯誤！未找到引用源。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 Page 11 of 11ReportIEC62366 checklistClause條款Requirement要求Remark解釋Verdict判定4GENERAL REQUIREMENTS/總要求General Requirements/總要求Usability Engineering Process/可用性工程過程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，以確保患者、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 Process address user interactions with the medical device according to the acpanying 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 ManualComplianceAre Residual Risks associated 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險是否推定可接受？Risk analysis report 。Compliance manufacturer shall subject the information for safety used as a risk control to the usability engineering process (., warnings or limitation of use in the acpanying documents, marking, etc.).對于做為風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)被認為是超出風險控制措施的（即非正常使用）Risk analysis report ComplianceThe 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’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)文檔和風險管理文檔）的一部分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 significance of any modifications depending on the results of the risk analysis and documented可用性工程調(diào)整取決于風險分析確認的設(shè)計更改的重要程度Risk analysis repo
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