CE可用性工程评估报告ENWord格式.docx

1、说明验证人审批人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 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

2、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?User Manual;Quality manual, procedure document;ComplianceDoes 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

3、?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？User Manual4.1.2Are 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 ;4.1.3 manufacturer shall subject

4、 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, 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Disregarding such information for safety is considered beyond any further reasonable means of r

5、isk 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 report 4.2The 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。The records and other documents that make up the usability engineering file may form part of other documents and files

6、 （e.g., a manufacturers 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Quality manual, procedure document4.3Scaling of the Usability Engineering effort/可用性工程的调整The usability engineering process is scaled based on the

7、 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5USABILTY ENGINEERING PROCESS/可用性工程过程5.1Application specification/应用的规格Application of Medical Device in the usability engineering file is specified by the manufacturer and include

8、s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

9、 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5.2Frequently used functions/常用功能Are frequently used functio

10、ns that involve User 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？5.3Identification of hazards and hazardous situations related 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Id

11、entification of characteristics related to 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 related to safety, the following are considered:在识别安全特征时，要考虑下列因素： applicatio

12、n specification, including user profile（s）;应用的规格，包括用户特征；frequently used functions.常用功能。Results of this identification characteristics 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 5.3.2Identification of known or foreseeable hazards and hazardous situations/识别已知的或可预

13、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.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Reas

14、onably 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 t

15、he 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）; 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

16、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;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； r

17、esults 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。5.4Primary operating functions/主要操作功能The manufacturer has determined the primary operating

18、 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。The inputs to the primary operating 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。5.5Usability Specification/可用性规范manufacturer developed

19、a usability specification recorded in the usability engineering file as part of the usability engineering 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。The 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

20、工程文档里。可用性规范可以整合于其它规范。The 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 Hazardous Situations related to the Usability;关系可用性的危害和危害处境 known or foreseeable use errors associated with the Medical Device已知的或可预见的关系医疗器械的使用错误。The usab

21、ility 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 case Use Scenarios; 合理可预见的最坏使用情景； User Interface requirements for the primary operating functions,

22、 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； Requirements for determining whether primary operating functions are easily recognizable 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5.6Usability validation plan/可用性确认计划The manufacturer has developed and maintains a usability validation plan specify

23、ing:制造商需制定并维护可用性确认计划，以规定： any method used for validation of the usability of the primary operating functions;对于主要操作功能的可用性的确认方法； the criteria for determining successful validation of the usability of the primary operating functions based on the usability specification;基于可用性规范，对主要操作功能可用性的确认标准 the invo

24、lvement of representative intended users 包含的预期用户代表usability validation performed in a laboratory setting :可用性确认实施的实验室设置：Test report.usability validation performed in a simulated use environment :可用性确认实施于模拟使用环境：Test reportusability validation performed in the actual use environment :可用性确认实施于真实使用环境：Th

25、e 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 case use 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。The usability 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。5.7

26、User 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 engineering 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户界面。Products do not have this requirementnon-compliance5.8Usability verification /可用性验证Manufacturer verified the implementation of the Medical