Mapping of Standard Requirements to Document Sections
| IEC 62366-1:2015 Section | Title | Document Section |
|---|---|---|
| 5.4 | Identify and describe Hazard-Related Use Scenarios | 1 |
| 5.5 | Select the Hazard-Related Use Scenarios for Summative Evaluation | 1 |
Summary
The goal of the list of Hazard-Related Use Scenarios is to gather all Use Scenarios which could be associated with a Hazard, e.g., if a user doesn’t understand a certain feature of the app (bad design leading to poor usability), then a Hazard could be encountered which could subsequently lead to a Hazardous Situation.
1. Hazard-Related Use Scenarios
Fill out this list with Use Scenarios which could be Hazard-related. A good rule of thumb is to have 3-10 scenarios, based on the risk profile of your software.
Also, note that you should prefer to create a spreadsheet for this table (e.g., in Google Sheets) as putting a table in a document will surely lead to chaos. But then again, there’s always a certain level of chaos in regulatory documentation.
| 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 |
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