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# IEC 62366-1:2015 Mapping of Requirements to Documents

This table maps all requirements of the IEC 62366-1:2015 (by section) to the relevant documents.

> Note that the document names in the "Fulfilled in Document" column are based on the OpenRegulatory
> templates. You'll probably have a different system for assigning document names, so feel free to rename
> them.

| Section | Title                                                                              | Fulfilled in Document                |
| ------- | ---------------------------------------------------------------------------------- | ------------------------------------ |
| 4.1.1   | Usability Engineering Process                                                      | SOP Integrated Software Development  |
| 4.1.2   | Risk Control as it relates to User Interface design                                | Risk Table                           |
| 4.1.3   | Information for Safety as it relates to Usability                                  | Usability Evaluation Report          |
| 4.2     | Usability Engineering File                                                         | Usability Evaluation Plan, Report    |
| 4.3     | Tailoring of the Usability Engineering effort                                      | Usability Evaluation Plan            |
| 5.1     | Prepare Use Specification                                                          | SOP Integrated Software Development  |
| 5.2     | Identify User Interface characteristics related to Safety and potential Use Errors | Software Requirements List           |
| 5.3     | Identify known or foreseeable Hazards and Hazardous Situations                     | Risk Table                           |
| 5.4     | Identify and describe Hazard-Related Use Scenarios                                 | List of Hazard-Related Use Scenarios |
| 5.5     | Select the Hazard-Related Use Scenarios for Summative Evaluation                   | List of Hazard-Related Use Scenarios |
| 5.6     | Establish User Interface Specification                                             | Software Requirements List           |
| 5.7.1   | Establish User Interface Evaluation Plan / General                                 | Usability Evaluation Plan            |
| 5.7.2   | Formative Evaluation planning                                                      | Usability Evaluation Plan            |
| 5.7.3   | Summative Evaluation planning                                                      | Usability Evaluation Plan            |
| 5.8     | Perform User Interface design, implementation and Formative Evaluation             | SOP Integrated Software Development  |
| 5.9     | Perform Summative Evaluation of the Usability of the User Interface                | Usability Evaluation Protocol        |
| 5.10    | User Interface of Unknown Provenance                                               | (not applicable)                     |