CE-可用性工程的评估报告材料(EN 62366).doc

实用标准文案 精彩文档 实用标准文案 精彩文档 EN 62366:2008 Checklist/检查表 Medical devices Application 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 实用标准文案 4 GENERAL REQUIREMENTS/总要求 4.1 General Requirements/总要求 4.1.1 Usability 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; Compliance Does 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 disposal? 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 Manual Compliance 4.1.2 Are 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 ; Compliance 4.1.3 manufacturer 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; Compliance Disregarding such information 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 Compliance 4.2 The 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; Compliance The records and other documents that make up the usability engineering file may form part of other documents and files (e.g., a manufacturer’s product design file or risk management file), (see List of docume