Mapping Standard Requirements to Document Sections
| IEC 62366-1:2015 Section | Title | Document Section |
|---|---|---|
| 5.4 | Identification and Description of Hazard-Related Use Scenarios | 1 |
| 5.5 | Selection of Hazard-Related Use Scenarios for Summative Evaluation | 1 |
Overview
The purpose of the Hazard-Related Use Scenarios list is to identify all potential use cases that could be linked to a hazard. For example, if users have difficulty understanding a feature of the application due to poor design and usability, this could result in a hazard and potentially lead to a hazardous situation.
1. Hazard-Related Use Scenarios
Populate this list with use scenarios that might be associated with a hazard. A practical guideline is to include between 3-10 scenarios, depending on the risk profile of your application.
It is advisable to use a spreadsheet (such as Google Sheets) for this table, as including it in a document can become disorganized. However, regulatory documentation often involves a degree of complexity.
| ID | User Group | Description | App State / Environment | Tasks | Acceptance Criteria |
|---|---|---|---|---|---|
| 1 | Physician | Assess COVID score | 1) App is installed 2) App displays patient result |
Understand COVID score and initiate further medical treatment | COVID score is understood correctly |