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1、Page 11 of 11EN 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IEC 62366 checklistClauseRequirementRemarkVerdict条款要求解释判定4GENERAL REQUIREMENTS/
2、总要求4.1General Requirements/ 总要求4.1.1U SABILITY ENGINEERING PROCESS/W|性工程过程Has the manufacturer established, documented and maintained a usability engineering process to provide safety for the patient , user and others 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
3、的 安全？User Manual;Quality manual, procedure document;ComplianceDoes the P ROCESS address user intera ctions 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
4、 交互，如运输、存储、安装、操作、维护、维修和 废弃？User ManualCompliance4.1.2Are RESIDUAL RISKS associated with USABILITY of 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？Risk analysis report ;Compliance4.1.3manufacturer shall subject t
5、he 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, 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 ;User Manual;ComplianceDisregarding such information for safety is conside
6、red 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)Risk analysis reportCompliance4.2The 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 document;ComplianceIEC 62366 checklist
7、ClauseRequirementRemarkVerdict条款要求解释判定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
8、档和风险管理文档)的一部分Quality manual, procedure documentCompliance4.3Scaling of the usability engineering effort/ 可用性工程的调整The usability engineering process is scaled based 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Risk anal
9、ysis reportCompliance5USABILTY ENGINEERING PROCESS/可用性工程过程5.1Application specification/ 应用的规格Application of M edical 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
10、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；User ManualComplianceintended 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；User ManualComplianceintended part of the body or type of tissue applied to or interacted with;预期使用的身体部
11、位或组织；User ManualComplianceintended 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 ManualComplianceIEC 62366 checklistClauseRequirementRemarkVerdict条款要求解释判定operating principle(s)操作原理User ManualComplian
12、ce5.2Frequently used functions/常用功能Are frequently used functions that involve USERinteraction with the M edical d evice 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？User ManualCompliance5.3Identification of hazards and hazardous situations related
13、 to usability/识别可 用性相关的危害和危害处境5.3.1Identification of characteristics to safety / 识别安全特征Identification of characteristics related tosafety(part of a RISK analysis ) that focuses on usability performed according to ISO 14971:2007, 4.2.应按ISO 14971:2007, 4.2的要求识别专注十可用性的安全特征Risk analysis reportCompliance
14、During the identification characteristics related to safety , the following are considered:在识别安全特征时，要考虑下列因素：application specification, includinguserPROFILE (S); and应用的规格，包括用户特征；frequently used functions.常用功能。User ManualComplianceResults of this identification characteristics related to safety record
15、ed 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User ManualCompliance5.3.2Identification of known or foreseeablehazards and hazardous situations /识另iJ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
16、:2007, 4.3.制造尚要按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Risk analysis reportComplianceIdentification 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 reportComplianceIEC 62366 checklistClauseRequirementRemarkVerdict条款要求解释判定Reasonably foreseeab
17、le sequences or combinations of events involving theUSERINTERFACE 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。Risk analysis reportComp
18、lianceDuring 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, includinguser 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 exi
19、sting 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
20、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。Risk analysis reportUser ManualComplianceThe results of this identification ofhazards ,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。Risk analysis report
21、Compliance5.4P RIMARY 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 ManualComplianceIEC 62366 checklistClauseRequirementRemarkVerdict条款要求解释判定The inputs to the primary operating
22、 functions include frequently used functions and functions related to safety of the medical device主要操作功能的输入包括常用功能和关系医疗器械安 全的功能。User ManualCompliance5.5U SABILITY SPECIFICATION /可用性规范MANUFACTURER developed a USABILITY SPECIFICATION recorded in the usability engineering file as part of the USABILITY E
23、NGINEERING PROCESS制造商应制定可用性规范，记录于可用性工程文档 里作为可用性工程过程的一部分。Quality manual, procedure documentComplianceThe USABILITY SPECIFICATION recorded in USABILITY ENGINEERING FILE . The USABILITY SPECIFICATION may be integrated into other specifications可用性规范记录于可用性工程文档里。可用性规范 可以整合于其它规范。Quality manual, procedure d
24、ocumentComplianceThe USABILITY specification includes:可用性规范包括：application specification;应用的规格；PRIMARY OPERATING FUNCTIONS主要操作功能HAZARDS and H azardous situations related to the usability； and关系可用性的危害和危害处境known or foreseeable use errors associated with the M EDICAL DEVICE已知的或可预见的关系医疗器械的使用错误。User Manua
25、lRisk analysis reportComplianceThe USABILITY specification describes at least:可用性规范至少要描述：use scenarios related to the primary operating functions , including关于主要操作功能的使用情景，包括：frequent Use Scenarios, and常见的使用情景reasonably foreseeable worst caseU SE SCENARIOS;合理可预见的最坏使用情景；User ManualRisk analysis report
26、ComplianceIEC 62366 checklistClauseRequirementRemarkVerdict条款要求解释判定U SER INTERFACE requirements for the PRIMARY OPERATING FUNCTIONS , including those to mitigate RISK;主要操作功能对于用户界面的要求，包括降低风险的 那些；Risk analysis reportComplianceRequirements for determining whetherPRIMARYoperating functions are easily re
27、cognizable by the USER.用于决定主要操作功能是否易于被用户认知的要求Risk analysis reportCompliance5.6USABILITY VALIDATION plan/ 可用性确认计划The manufacturer has developed and maintains a USABILITY VALIDATION plan specifying:制造商需制定并维护可用性确认计划，以规定：User ManualComplianceany method used for validation of the usability of the PRIMARY
28、 OPERATING FUNCTIONS ;对于主要操作功能的可用性的确认方法；User ManualCompliancethe criteria for determining successfulvalidationof the USABILITY of the primary operating functions based on the usability specification ; and基于可用性规范，对主要操作功能可用性的确认标准User ManualCompliancethe involvement of representative intendedusers包含的预期
29、用户代表User ManualComplianceusability validation performed in a laboratory setting 可用性确认实施的实验室设置：Test report.Complianceusability validation performed in a simulated use environment可用性确认实施于模拟使用环境：Test reportComplianceusability validation performed in the actual use environment可用性确认实施于真实使用环境：Test reportC
30、omplianceIEC 62366 checklistClauseRequirementRemarkVerdict条款要求解释判定The USABILITY validation plan addresses:可用性确认计划包括：frequent Use Scenarios, and常见的使用情景；reasonably foreseeable worst caseuse scenarios合理可预见的最坏使用情景that are identified in the usability specification都要在可用性规范中识别。User ManualComplianceThe usab
31、ility validation plan recorded in the USABILITY ENGINEERING FILE可用性确认计划应记录与可用性工程文档。User ManualCompliance5.7USER interface design and implementation/用户界面设计和实施manufacturer designed and implemented the user interface as described in the usability specification utilizing, as appropriate, usability engin
32、eering methods and techniques制造商应使用可用性工程的方法和技术来开发并实施 可用性规范描述的用尸界向。Products do not have this requirementnoncompliance5.8U SABILITY VERIFICATION /可用性验证manufacturer verified the implementation of the M EDICAL DEVICE USER interface design according to the USABILITY SPECIFICATION制造商应根据可用性规范来验证医疗器械用户界面设 计
33、的实施。Products do not have this requirementnoncomplianceThe results of the verification are recorded in USABILITY ENGINEERING FILE验证的结果应记录于可用性工程文档。Products do not have this requirementnoncompliance5.9U SABILITY VALIDATION/可用性确认The MANUFACTURER has validated the U SABILITY of the MEDICAL DEVICE accordi
34、ng to the usability VALIDATION plan制造商应根据可用性确认计划来确认医疗器械用户界 面的可用性。Products do not have this requirementnoncomplianceThe results are recorded in the usability ENGINEERING FILE确认的结果应记录于可用性工程文档。Products do not have this requirementnoncomplianceIEC 62366 checklistClauseRequirementRemarkVerdict条款要求解释判定For
35、 the acceptance criteria documented in the USABILITY VALIDATION plan that are not met:对于没后可用性确认计划中制定的未被满足的接收准 则：-further U ser interface design and implementation activities are performed; or需要进行进一步的用户界面设计和执行；或-if further improvement is not practicable, the MANUFACTURER may gather and review data an
36、d literature to determine if the medical benefits of the INTENDED USE outweigh the RISK arising from USABILITY problems如果进一步的改进不现实，制造商需要收集并评审数 据和文献，以确定预期用途的医疗收益是否超过可用 性问题带来的风险。To perform this step, the MANUFACTURER needs to estimate the RISK arising from USABILITY problems.为此，制造商需评估可用性问题带来的风险。Produc
37、ts do not have this requirementnoncompliance6ACCOMPANYING DOCUMENTS/随机文件The A ccompanying document includes a summary of the M edical device application specification随机文件应包括医疗器械应用的规格的总结。User ManualComplianceA concise description of the M edical device , its operating principles, significant physical
38、 and performance characteristics and intended UserP ROFILE are included in the A CCOMPANYING DOCUMENT随机文件包括医疗器械、工作原理、重要的物理和性 能特性和预期用户的特征的简要描述。User ManualComplianceThe A CCOMPANYING document is written at a level consistent with the intended operator profile随机文件的编写要与用户特征的水平相一致。User ManualComplianceTh
39、e A CCOMPANYING document for equipment are, optionally, provided electronically设备的随机文件或者可以电子文件提供。User ManualComplianceIEC 62366 checklistClauseRequirementRemarkVerdict条款要求解释判定U SABILITY ENGINEERING PROCESS includes the information that will need to be provided as a hard copy or as markings on M edic
40、al d evice when accompanying documents are provided electronically当随机文件是电子形式时，可用性工程过程应包括 在医疗器械上需要以硬拷贝或标识提供的信息。User ManualComplianceIEC 62366 checklistClauseRequirementRemarkVerdict条款要求解释判定7TRAINING AND MATERIALS FOR TRAINING/培训和培训材料The required training on the medical device for safe and effective u
41、se of primary operating functions by the intended U SER is given by:由预期用户安全有效使用医疗器械主要操作功能的必 须培训包括：User ManualCompliancenecessary training materials provided by the manufacturer;制造商提供的必要的培训材料；User ManualCompliancenecessary training materials are available; or必要培训材料的可兼得性；User ManualCompliancethe manuf
42、acturer provides training或制造商提供培训User ManualComplianceThe A CCOMPANYING document describes the available training options(Recommendation: accompanying document include the suggested duration and frequency of such training)随机文件要描述可获得的培训选项(推荐：随机文件包括此类培训时间和频度的建议)User ManualComplianceIntended use and user profile (S) are the basis for TRAINING and TRAINING material预期用途和用户特征是培训和培训材料的基础。User ManualCompliance