学 海 无 涯
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 1
学 海 无 涯 4 4.1 4.1.1 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 User Manual; Compliance and maintained a USABILITY ENGINEERING PROCESS to Quality manual, procedure provide SAFETY for the PATIENT, USER and others document; 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? Does the PROCESS address USER INTERActions with User Manual 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？ Are RESIDUAL RISKS associated with USABILITY of the Risk analysis report ; 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？ Compliance 4.1.2 Compliance 4.1.3 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, Risk analysis report ; User Manual; Compliance 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 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） 4.2 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 Compliance document; Compliance 1
学 海 无 涯 The records and other documents that make up the USABILITY ENGINEERING FILE MAY form part of other documents and files (e.g., a MANUFACTURER’S product design file or RISK MANAGEMENT FILE), (SEE List of documents make up the UE file) 组成可用性工程文档的记录和其它文件可以是其它文档（如技术文档和风险管理文档）的一部分 4.3 Scaling of the USABILITY ENGINEERING effort/可用性工程的调整 The USABILITY ENGINEERING PROCESS is scaled based Risk analysis report on the significance 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确认的设计更改的重要程度 5 5.1 USABILTY ENGINEERING PROCESS/可用性工程过程 Application specification/应用的规格 Application of MEDICAL DEVICE in the USABILITY ENGINEERING FILE is specified by the MANUFACTURER and includes 可用性工程文档中的医疗器械的应用由制造商决定，包括： – intended medical indication (e.g., conditions(s) or disease(s) to be screened, monitored, treated, diagnosed, or prevented); 预期医学用途，如预期要筛查、监护、治疗、诊断或预防的状态或疾病； – intended PATIENT population (e.g., age, weight, health, condition); 预期患者群，如年龄、体重、健康和社会条件； – intended part of the body or type of tissue applied to or interacted with; 预期使用的身体部位或组织； – intended conditions of use (e.g.. environment including hygienic requirements, frequency of use, location, mobility); and 预期的使用状态，如环境包括卫生要求、使用频度、地点和机动性； – operating principle(s) 操作原理 5.2 Frequently used functions/常用功能 User Manual Compliance User Manual Compliance User Manual Compliance User Manual Compliance User Manual Compliance - - Compliance Quality manual, procedure Compliance document 1
EN62366 医疗器械可用性工程评估报告(2020年九月整理).doc
