EN62366_2008 医疗器械可用性工程评估报告

En 623663336902008检查清单/检查清单Medical devicesapplication of usability engineering to medical devices可用性工程在医疗器械中的应用产品名称/产品名称报告参考否/编号。版本/版本号：验证者：Date of issue/发布日期：版本修订记录：日期版本说明认证者批准者4GENERAL REQUIREMENTS/一般要求4.1General Requirements/一般要求4.1.1可维护性工程流程/可用性工程流程Has the manufacturer establish，documented and maintained a usability engineering process to provide safety for the patient，user and others制造商是否建立、记录和维护可用性工程流程，以确保处理患者、用户和产品适用性的其他人的安全？User ManualQuality manual，procedure documentCompliancedoes the process address user interactions with the medical device according to the accompaning document including，but not limited to transport此过程用于解决与随机文件特定医疗设备(如运输、存储、安装、操作、维护、维修、处置)的用户交互吗？User ManualCompliance4.1.2are resdual risks associated with usability of the medical device pressure to be acceptable，unless there is objective evidence to the contract关系医疗设备可用性的剩馀风险估计为可接受吗？Risk analysis reportCompliance4.1.3manufacturer shall subject the information for safety used as a risk control to the usability engineering process(e . g .warnings or limitiongs) 。制造商必须将安全信息作为风险管理措施包括在可用性工程流程的控制中Risk analysis reportUser ManualCompliancedisregarding such information for safety is consired beyond any further reasonable means of risk control无视安全信息的行为应被视为超出风险管理措施(即异常使用)Risk analysis reportCompliance4.2the results of the usability engineering process are recorded in the usability engineering file可用性设计过程的结果将记录在可用性设计文档中。Quality manual，procedure documentCompliancethe records and other documents that make up the usability engineering file may form part of other documents and files(e . g .a manufacturer(see list of documents makeup the UE file)构成可用性工程文档的记录和其他文件可以是其他文档(例如技术文档和风险管理文档)的一部分Quality manual，procedure documentCompliance4.3可用性工程导出/可用性工程调整scaling of the usability engineering effortthe usability engineering process is scaled based on the signiance of any modifications depending on the results of the risk analysis and documented可用性工程调整取决于风险分析中确定的设计更改的重要性Risk analysis reportCompliance5可维护性工程流程/可用性工程流程5.1应用程序规格/应用的规格application of medical device in the usability engineering file is specified by the manufacturer and includes医疗设备在可用性工程文档中的应用由制造商确定，如下所示：-intensed medical indication(e . g .conditions(s)or disease(s)to be screened，monitored，treated，to be screened预期检查、监护、治疗、诊断或预防的状态或疾病等预定医疗用途；User ManualComplianceintensded patient population(e . g .age、weight、health、condition)；预期患者群体，如年龄、体重、健康和社会条件；User ManualComplianceintensded part of the body or type of tissue applied to or interacted with；预期的身体部位或组织；User ManualComplianceintensded conditions of use(e . g.environment including hygienic requirements，frequency of use，location，mobility)；And环境、使用频率、位置和移动性等预期使用状态；User ManualComplianceoperating principle(s)工作原理User ManualCompliance5.2Frequently used functions/公用功能are frequently used functions that invoice user interaction with the medical device are determined and recorded in the usability engineering file可用性工程文档是否标识并记录了与用户与医疗设备交互相关的一般功能？User ManualCompliance5.3与识别hazards and hazardous situations related to usability/可用性相关的风险和风险情况5.3.1identification of character istics to safety/标识安全功能identification of character istics related to safety(part of a risk analysis)that focuss on usability performed according to iso 149713333必须根据ISO 14971:2007，4.2的要求确定侧重可用性的安全特性Risk analysis reportComplianceduring the identification character istics related to safety，the following are consired :识别安全特征时，请考虑以下因素：application specification，including user profile(s)；And应用的规格，包括自定义特性；-frequently used functions。常用功能。User ManualComplianceresults of this identification character istics related to safety recorded in the usability engineering file安全特征识别结果必须记录在可用性工程文档中User ManualCompliance5.3.2识别已知的或可预测的风险和风险情况/识别可预测的hazards and hazardous situationsmanufacturer has identified known or foreseable hazards(part of a risk analysis)related to usability according to iso 14971:7制造商必须根据ISO 14971:2007，4.3的要求确定与可用性相关的已知或可预测风险Risk analysis reportComplianceidentification of hazards considered hazards to patients，users and other persons识别损失时，必须考虑对患者、操作员和其他人的风险Risk analysis reportCompliancereasonbluy foreseable sequences or combinations of events invoicing the user interface that can result in a hazardous situation associated with thethe severity of the resulting possible harm is determined。已确定合理、可预测事件的顺序和组合，包括可能导致危险情况的医疗设备用户界面。认识到可能造成的损失的严重性。Risk analysis reportComplianceduring the identification of hazards and hazardous situations，the following was considered :识别风险和风险情况时，请考虑以下几点：-application specification，including user ro file(s)；应用的规格，包括自定义特性；task related requirements；任务相关要求使用context of use使用的背景；information on hazards and hazardous situations known for existing user interfaces of medical devices of a similar type，if available现有类似医疗设备用户界面的已知风险和风险情况信息；-preliminary USE SCENARIOS；初步使用方案；-