文档介绍：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
General Requirements/总要求
Usability 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;
Compliance
Does the Process address user interactions with the medical device according to the panying 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 Manual
Compliance
Are 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 ;
Compliance
manufacturer shall subject the information for safety used as a risk control to the usability engineering process (., warnings or limitation of use in the panying 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;
Compliance
Disregarding 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
Compliance
The results of the usability engineering process are recorded in the usability engineering file
可用性工程过程的结果记录于可用性工程文档。
Quality manual, procedure document;
Compliance
The records and other documents that make up the usability engineering file may form part of other documents and files (., a manufacturer’s product design file or risk management file),
(see Lis