Templates IEC 62366 Templates

Updated September 29, 2022

Template: List of Hazard-Related Use Scenarios

Dr. Oliver Eidel

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Related Documents

The following templates are Documents or SOPs related to this template. That means that they mention this template somewhere and (most likely) contain instructions on how and when to fill it out.

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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 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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