CE_可用性工程评估报告(EN62366)

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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 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 and User Manual; maintained a USABILITY ENGINEERING PROCESS to Quality manual, provide SAFETY for the PATIENT, USER and others procedure 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 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 Risk analysis report ; 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？ 4.1.3 MANUFACTURER SHALL subject the information for Compliance User Manual Compliance 4.1.2 Compliance Risk analysis report ; Compliance safety used as a RISK CONTROL to the USABILITY User Manual; ENGINEERING PROCESS (e.g., warnings or limitation of use in the ACCOMPANYING 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 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 Quality manual, recorded in the USABILITY ENGINEERING FILE procedure document; 可用性工程过程的结果记录于可用性工程文档。 Compliance Compliance ..........

. . . 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 on Risk analysis report 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., User Manual 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 User Manual 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； User Manual Compliance Compliance User Manual Compliance Compliance - - Compliance Quality manual, procedure document Compliance ..........

. . . – operating principle(s) 操作原理 5.2 Frequently used functions/常用功能 Are frequently used functions that involve USER User Manual interaction with the MEDICAL DEVICE are determined and recorded in the USABILITY ENGINEERING FILE? 在可用性工程文档中是否确定并记录了涉及用户与医疗器械交互的常用功能？ 5.3 5.3.1 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY/识别可用性相关的危害和危害处境 Identification of characteristics to SAFETY/识别安全特征 Identification of characteristics related to Risk analysis report SAFETY (part of a RISK ANALYSIS) that focuses on USABILITY performed according to ISO 14971:2007, 4.2. 应按ISO 14971:2007, 4.2的要求识别专注于可用性的安全特征 During the identification characteristics User Manual related to SAFETY, the following are considered: 在识别安全特征时，要考虑下列因素： – application specification, including USER PROFILE(S); and 应用的规格，包括用户特征； –frequently used functions. 常用功能。 Results of this identification characteristics User Manual related to SAFETY recorded in the USABILITY ENGINEERING FILE 安全特征识别的结果应记录于可用性工程文档 5.3.2 Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS/识别已知的或可预见的危害和危害处境 MANUFACTURER has identified known or foreseeable HAZARDS (part of a RISK ANALYSIS) related to USABILITY according to ISO 14971:2007, 4.3. User Manual Compliance Compliance Compliance Compliance Compliance Compliance Risk analysis report 制造商要按ISO 14971:2007, 4.3的要求识别可用性相关的已知的或可预见的危害 Identification of HAZARDS considered HAZARDS to PATIENTS, USERS and other persons 识别危害时要考虑对患者、操作者和其他人员的危害 Risk analysis report Compliance ..........

. . . Reasonably foreseeable sequences or combinations of events involving the USER INTERFACE that can result in a HAZARDOUS SITUATION associated with the MEDICAL DEVICE were identified. The SEVERITY of the resulting possible HARM is determined. 包括可能导致危害处境的医疗器械用户界面的合理可预见的事件的次序和组合已经被识别。导致的可能的危害的严重程度已确定。 During the identification of HAZARDS and HAZARDOUS SITUATIONS, the following was considered: 在识别危害和危害处境时，下列需要考虑： – application specification, including USER ROFILE(S); 应用的规格，包括用户特征； – task related requirements; 任务相关的要求； – 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; 对于现存的类似的医疗器械用户界面的已知的危害和危害处境信息； – preliminary USE SCENARIOS; 初步的使用情景； – possible USE ERRORS; 可能的使用错误； – if an incorrect mental model of the operation of the MEDICAL DEVICE can cause a USE ERROR resulting in a HAZARDOUS SITUATION; and 操作医疗器械的错误精神模型是否会引起导致危害处境的使用错误； – results of the review of the USER INTERFACE 用户界面的评审结果。 The results of this identification of HAZARDS, HAZARDOUS SITUATIONS and SEVERITY are recorded in the USABILITY ENGINEERING FILE. 识别危害、危害处境和严重程度的结果要记录在可用性工程文档里。 PRIMARY OPERATING FUNCTIONS/主要操作功能 The manufacturer has determined the PRIMARY OPERATING FUNCTIONS and recorded in the USABILITY ENGINEERING FILE 制造商已经确定了主要操作功能并记录在可用性工程文档里。 User Manual Risk analysis report Compliance Risk analysis report User Manual Compliance Risk analysis report Compliance 5.4 Compliance ..........