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1、 Page 2 of 13 Report No. 错误！未找到引用源。EN 62366:2008 Checklist/检查表Medical devicesApplication of usability engineering to medical devices可用性工程于医疗器械的应用Product Name/产品名称Report Reference No/编号.:Version/版本号：验证人：Date of issue/发布日期:版本修改记录：日期版本说明验证人审批人 Page 11 of 11IEC62366 checklistClause条款Requirement要求Remark解
2、释Verdict判定4GENERAL REQUIREMENTS/总要求4.1General Requirements/总要求4.1.1Usability Engineering Process/可用性工程过程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、记录并维持了一个
3、可用性工程过程，以确保患者、用户和其它涉及产品适用性的人的安全?User Manual;Quality manual, procedure document;ComplianceDoes the Process address user interactions with the medical device according to the accompanying document including, but not limited to transport, storage, installation, operation, maintenance, repair and dispos
4、al?该过程是否用于解决用户按随机文件与医疗器械的交互，如运输、存储、安装、操作、维护、维修和废弃？User ManualCompliance4.1.2Are Residual Risks associated with Usability of the medical Device presumed to be acceptable, unless there is objective evidence to the contrary and documented?关系医疗器械可用性的剩余风险是否推定可接受？Risk analysis report ;Compliance4.1.3manuf
5、acturer shall subject the information for safety used as a risk control to the usability engineering process (e.g., warnings or limitation of use in the accompanying documents, marking, etc.).对于做为风险控制措施的安全信息，制造商应把它纳入可用性工程过程的控制Risk analysis report ;User Manual;ComplianceDisregarding such information
6、for safety is considered beyond any further reasonable means of risk control忽视安全信息的行为应被认为是超出风险控制措施的（即非正常使用）Risk analysis report Compliance4.2The results of the usability engineering process are recorded in the usability engineering file可用性工程过程的结果记录于可用性工程文档。Quality manual, procedure document;Complian
7、ceThe records and other documents that make up the usability engineering file may form part of other documents and files (e.g., a manufacturers product design file or risk management file), (see List of documents make up the UE file)组成可用性工程文档的记录和其它文件可以是其它文档（如技术文档和风险管理文档）的一部分Quality manual, procedure
8、 documentCompliance4.3Scaling of the Usability Engineering effort/可用性工程的调整The usability engineering process is scaled based on the significance of any modifications depending on the results of the risk analysis and documented可用性工程调整取决于风险分析确认的设计更改的重要程度Risk analysis report Compliance5USABILTY ENGINEER
9、ING PROCESS/可用性工程过程5.1Application specification/应用的规格Application of Medical Device in the usability engineering file is specified by the manufacturer and includes可用性工程文档中的医疗器械的应用由制造商决定，包括：- intended medical indication (e.g., conditions(s) or disease(s) to be screened, monitored, treated, diagnosed,
10、or prevented);预期医学用途，如预期要筛查、监护、治疗、诊断或预防的状态或疾病；User ManualCompliance intended patient population (e.g., age, weight, health, condition);预期患者群，如年龄、体重、健康和社会条件；User ManualCompliance intended part of the body or type of tissue applied to or interacted with;预期使用的身体部位或组织；User ManualCompliance intended cond
11、itions of use (e.g. environment including hygienic requirements, frequency of use, location, mobility); and预期的使用状态，如环境包括卫生要求、使用频度、地点和机动性；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 w
12、ith the Medical Device are determined and recorded in the usability engineering file?在可用性工程文档中是否确定并记录了涉及用户与医疗器械交互的常用功能？User ManualCompliance5.3Identification of hazards and hazardous situations related to usability/识别可用性相关的危害和危害处境5.3.1Identification of characteristics to safety/识别安全特征Identification
13、of characteristics related to safety (part of a risk analysis) that focuses on usability performed according to ISO 14971:2007, 4.2.应按ISO 14971:2007, 4.2的要求识别专注于可用性的安全特征Risk analysis report ComplianceDuring the identification characteristics related to safety, the following are considered:在识别安全特征时，要
14、考虑下列因素： application specification, including user profile(s); and应用的规格，包括用户特征；frequently used functions.常用功能。User ManualComplianceResults of this identification characteristics related to safety recorded in the usability engineering file安全特征识别的结果应记录于可用性工程文档 User ManualCompliance5.3.2Identification o
15、f known or foreseeable hazards and hazardous situations/识别已知的或可预见的危害和危害处境manufacturer has identified 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的要求识别可用性相关的已知的或可预见的危害Risk analysis report ComplianceIdentification of hazards considered hazards to patients,
