医疗器械可用性工程评估报告.doc

EN 62366:2023 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
GENERAL REQUIREMENTS/总规定

4.1
General Requirements/总规定

4.1.1
Usability 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性工程过程，以保证患者、用户和其它涉及产品合用性的人的安全?
User Manual;
Quality manual, procedure document;
Compliance

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献与医疗器械的交互，如运送、存储、安装、操作、维护、维修和废弃？
User Manual
Compliance
4.1.2

Are 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 ;

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, 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;

Compliance

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过风险控制措施的（即非正常使用）
Risk analysis report
Compliance
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 document;
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献可以是其它文档（如技术文档和风险管理文档）的一部分
Quality manual, procedure document
Compliance
4.3
Scaling 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限度
Risk analysis report
Compliance

5
USABILTY ENGINEERING PROCESS/可用性工程过程

5.1
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，涉及：
-
-

– 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、诊断或防止的状态或疾病；
User Manual
Compliance

– 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；
User Manual
Compliance

– 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；
User Manual
Compliance

– intended conditions of use (e.g.. environment including hygienic requirements, frequency of use, location, mobility); and
预期的使用状态，如环境涉及卫生规定、使用频度、地点和机动性；
User Manual
Compliance

– operating principle(s)
操作原理
User Manual
Compliance
5.2
Frequently used functions/常用功能

Are frequently used functions 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拟定并记录了涉及用户与医疗器械交互的常用功能？
User Manual
Compliance
5.3
Identification of hazards and hazardous situations related to usability/辨认可用性相关的危害和危害处境

5.3.1
Identification of characteristics to safety/辨认安全特性

Identification of characteristics related to safety (part of a risk analysis) that focuses on usability performed according to ISO 14971:2023, 4.2.
应按ISO 14971:2023, 4.2的规定辨认专注于可用性的安全特性
Risk analysis report
Compliance

During the identification characteristics related to safety, the following are considered:
在辨认安全特性时，要考虑下列因素：
– application specification, including user profile(s); and
应用的规格，涉及用户特性；
–frequently used functions.
常用功能。
User Manual
Compliance

Results of this identification characteristics related to safety recorded in the usability engineering file
安全特性辨认的结果应记录于可用性工程文档
User Manual
Compliance
5.3.2
Identification of known or foreseeable hazards and hazardous situations/辨认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 14971:2023, 4.3.
制造商要按ISO 14971:2023, 4.3的规定辨认可用性相关的已知的或可预见的危害
Risk analysis report
Compliance

Identification of hazards considered hazards to patients, users and other persons
辨认危害时要考虑对患者、操作者和其别人员的危害
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.
涉及也许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顺序和组合已经被辨认。导致的也许的危害的严重限度已拟定。
Risk analysis report
Compliance

During the identification of HAZARDS and HAZARDOUS SITUATIONS, the following was considered:
在辨认危害和危害处境时，下列需要考虑：

– application specification, including user rofile(s);
应用的规格，涉及用户特性；
– task related requirements;
任务相关的规定；
– 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;
也许的使用错误；
– 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。
Risk analysis report
User Manual
Compliance

The results of this identification of HAZARDS, HAZARDOUS SITUATIONS and SEVERITY are recorded in the USABILITY ENGINEERING FILE.
辨认危害、危害处境和严重限度的结果要记录在可用性工程文档里。
Risk analysis report

Compliance
5.4
Primary operating functions/重要操作功能

The manufacturer has determined the primary operating functions and recorded in the usability engineering file
制造商已经拟定了重要操作功能并记录在可用性工程文档里。
User Manual
Compliance

The inputs to the primary operating functions include frequently used functions and functions related to Safety of the Medical Device
重要操作功能的输入涉及常用功能和关系医疗器械安全的功能。
User Manual
Compliance
5.5
Usability Specification/可用性规范

manufacturer developed 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。
Quality manual, procedure document
Compliance

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工程文档里。可用性规范可以整合于其它规范。
Quality manual, procedure document
Compliance

The usability specification includes:
可用性规范涉及：
– application specification;
应用的规格；
– primary operating functions
重要操作功能
– hazards and Hazardous 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 Medical Device
已知的或可预见的关系医疗器械的使用错误。
User Manual
Risk analysis report

Compliance

The usability specification describes at least:
可用性规范至少要描述：

– use scenarios related to the primary operating functions, including
关于重要操作功能的使用情景，涉及：
– 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 Manual
Risk analysis report

Compliance

– User Interface requirements for the primary operating functions, including those to mitigate Risk;
重要操作功能对于用户界面的规定，涉及减少风险的那些；
Risk analysis report

Compliance

– Requirements for determining whether primary operating functions are easily recognizable by the User.
用于决定重要操作功能是否易于被用户认知的规定
Risk analysis report

Compliance
5.6
Usability 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 Manual

Compliance

– any method used for validation of the usability of the primary operating functions;
对于重要操作功能的可用性的确认方法；
User Manual

Compliance

– the criteria for determining successful validation of the usability of the primary operating functions based on the usability specification; and
基于可用性规范，对重要操作功能可用性的确认标准
User Manual

Compliance

– the involvement of representative intended users
包含的预期用户代表
User Manual

Compliance

usability validation performed in a laboratory setting :
可用性确认实行的实验室设立：
Test report.
Compliance

usability validation performed in a simulated use environment :
可用性确认实行于模拟使用环境：
Test report
Compliance

usability validation performed in the actual use environment :
可用性确认实行于真实使用环境：
Test report
Compliance

The usability validation plan addresses:
可用性确认计划涉及：
– 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辨认。
User Manual

Compliance

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。
User Manual

Compliance
5.7
User interface design and implementation/用户界面设计和实行

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行可用性规范描述的用户界面。
Products do not have this requirement
non-compliance
5.8
Usability verification /可用性验证

Manufacturer verified the implementation of the Medical 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的实行。
Products do not have this requirement
non-compliance

The 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 requirement
noncompliance
5.9
Usability Validation/可用性确认

The manufacturer has validated the Usability of the Medical Device according 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 requirement
non-compliance

The 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 requirement
non-compliance

For the acceptance criteria documented in the usability validation plan that are not met:
对于没有可用性确认计划中制定的未被满足的接受准则：
- further User 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 and literature to determine if the medical benefits of the INTENDED USE outweigh the RISK arising from USABILITY problems
假如进一步的改善不现实，制造商需要收集并评审数据和文献，以拟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。
Products do not have this requirement
non-compliance

6
ACCOMPANYING DOCUMENTS/随机文献

The Accompanying document includes a summary of the Medical Device application specification
随机文献应涉及医疗器械应用的规格的总结。
User Manual

Compliance

A concise description of the Medical Device, its operating principles, significant physical and performance characteristics and intended User Profile are included in the Accompanying document
随机文献涉及医疗器械、工作原理、重要的物理和性能特性和预期用户的特性的简要描述。
User Manual

Compliance

The Accompanying document is written at a level consistent with the intended operator profile
随机文献的编写要与用户特性的水平相一致。
User Manual

Compliance

The Accompanying document for equipment are, optionally, provided electronically
设备的随机文献或者可以电子文献提供。
User Manual

Compliance

Usability engineering process includes the information that will need to be provided as a hard copy or as markings on Medical Device when accompanying documents are provided electronically
当随机文献是电子形式时，可用性工程过程应涉及在医疗器械上需要以硬拷贝或标记提供的信息。
User Manual

Compliance

7
TRAINING AND MATERIALS FOR TRAINING/培训和培训材料

The required training on the medical device for safe and effective use of primary operating functions by the intended User is given by:
由预期用户安全有效使用医疗器械重要操作功能的必须培训涉及：
User Manual

Compliance

– necessary training materials provided by the manufacturer;
制造商提供的必要的培训材料；
User Manual

Compliance

– necessary training materials are available; or
必要培训材料的可获得性；
User Manual

Compliance

– the manufacturer provides training
或制造商提供培训
User Manual

Compliance

The Accompanying document describes the available training options
(Recommendation: accompanying document include the suggested duration and frequency of such training)
随机文献要描述可获得的培训选项
（推荐：随机文献涉及此类培训时间和频度的建议）
User Manual

Compliance

Intended use and user profile(s) are the basis for training and training material
预期用途和用户特性是培训和培训材料的基础。
User Manual

Compliance