list-of-hazard-related-use-scenarios

Copy the text below to a new Google Doc.

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

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.

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 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

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.