ce-可用性工程评估报告en6366.docxVIP

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 4 GENERAL REQUIREMENTS/ 总要求 4.1 General Requirements/ 总要求 4.1.1 U SABILITY E NGINEERING P ROCESS /可用性工程过程 Has the MANUFACTURER established, documented User Manual; Compliance and maintained a USABILITY ENGINEERING PROCESS to Quality manual, procedure provide S AFETY for the PATIENT , USER and others document; 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 ? Does the P ROCESS address USER INTERA ctions with User Manual Compliance 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？ 4.1.2 Are RESIDUAL R ISKS associated with U SABILITY of the Risk analysis report ; Compliance 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？ 4.1.3 MANUFACTURER SHALL subject the information for Risk analysis report ; Compliance safety used as a RISK CONTROL to the USABILITY User Manual; 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 Disregarding such information for SAFETY is Risk analysis report Compliance 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） 4.2 The results of the USABILITY ENGINEERING PROCESS Quality manual, procedure Compliance are recorded in the USABILITY ENGINEERING FILE document; 可用性工程过程的结果记录于可用性工程文档。 4.3 5 5.1 5.2  The records and other documents that make up the Quality manual, procedure document USABILITY ENGINEERING FILE MAY form part of other documents and files (e.g., a MANUFACTURER ’S product desig