CE-可用性工程评估报告材料EN62366.pdfVIP

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 大全 标准文案 4 GENERAL REQUIREMENTS/总要求 4.1 General Requirements/ 总要求 SABILITY NGINEERINGROCESS 4.1.1 U E P / 可用性工程过程 Has the MANUFACTURERestablished, documented and User Manual; Compliance maintained a USABILITY ENGINEERING PROCESSto Quality manual, AFETY PATIENT USER 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 ROCESSaddress USER INTERActions with User Manual Compliance MEDICAL DEVICE ACCOMPANYING the according to the DOCUMENTincluding, 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 R R associated with U of Risk analysis report ; Compliance ESIDUAL ISKS