CE-可用性工程的评估报告材料(EN62366).pdfVIP

实用标准文案 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 精彩文档 实用标准文案 4 GENERAL REQUIREMENTS/ 总要求 4.1 General Requirements/ 总要求 SABILITY NGINEERING ROCESS 4.1.1 U E P / 可用性工程过程 Has the MANUFACTURER established, documented User Manual; Compliance and maintained a USABILITY ENGINEERING PROCESS Quality manual, AFETY PATIENT USER to provide S for the , and others procedure 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 RISKS associated with U SABILITY of Risk analysis report ; Compliance the MEDICAL D EVICE presumed to be acceptable, unless the