This table correlates the requirements from IEC 62366-1:2015 (organized by section) to their respective documents.
Please note that the document titles in the “Fulfilled in Document” column are based on OpenRegulatory templates. You may have a different naming convention for your documents, so feel free to adjust them as needed.
Section | Title | Fulfilled in Document |
---|---|---|
4.1.1 | Usability Engineering Process | SOP Integrated Software Development |
4.1.2 | Risk Control related to User Interface design | Risk Table |
4.1.3 | Information for Safety related to Usability | Usability Evaluation Report |
4.2 | Usability Engineering File | Usability Evaluation Plan, Report |
4.3 | Tailoring the Usability Engineering effort | Usability Evaluation Plan |
5.1 | Preparing the Use Specification | SOP Integrated Software Development |
5.2 | Identifying User Interface characteristics tied to Safety and Potential Use Errors | Software Requirements List |
5.3 | Identifying known or anticipated Hazards and Hazardous Situations | Risk Table |
5.4 | Identifying and detailing Hazard-Related Use Scenarios | List of Hazard-Related Use Scenarios |
5.5 | Selecting Hazard-Related Use Scenarios for Summative Evaluation | List of Hazard-Related Use Scenarios |
5.6 | Establishing User Interface Specification | Software Requirements List |
5.7.1 | Creating a User Interface Evaluation Plan / General | Usability Evaluation Plan |
5.7.2 | Planning Formative Evaluation | Usability Evaluation Plan |
5.7.3 | Planning Summative Evaluation | Usability Evaluation Plan |
5.8 | Conducting User Interface design, implementation, and Formative Evaluation | SOP Integrated Software Development |
5.9 | Performing Summative Evaluation of User Interface Usability | Usability Evaluation Protocol |
5.10 | User Interface of Unknown Provenance | (not applicable) |