CE-可用性工程评估报告(EN 62366).doc

.EN 62366:2008 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 usabilit