EN62366-2025-医疗器械可用性工程评估报告

EN 62366：2025 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 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 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。3MANUFACTURER 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 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 ar...