OpenRegulatory Template

List of Hazard-Related Use Scenarios

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


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.

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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