精选优质文档-倾情为你奉上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专心-专注-专业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