CE-可用性工程评估报告(EN 62366).doc

Page page \* arabic2 of  NUMPAGES 13 Report No.  REF CP1 \* MERGEFORMAT 错误！未找到引用源。  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    Page page \* arabic11 of  NUMPAGES 11Report IEC?62366 checklistClause 条款Requirement 要求Remark 解释Verdict 判定 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 ; Compliance4.1.3 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; 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 are recorded in the usability engineering file 可用性工