Hazard-related use scenario template

Hazard-Related Use Scenario Template (IEC 62366, Medical Device)

99  (excl. GST/VAT)

This downloadable Hazard-related use scenario template will provide you with a framework to complete your hazard-related use scenarios. It may also be used as a benchmark for your existing hazard-related use scenarios. The template includes topics required by clauses 5.4 and 5.5 of IEC 62366-1:2015 + AMD:2020.

Description

Why it is useful

Hazard-related use scenarios are required to ensure that the design process is adequately controlled, the quality objectives of the product are met, and potential hazards in use are looked at during development and prevented if possible.

 

How to use it

1. If you are preparing the hazard-related use scenarios document for a specific product, fill in all components of this template.
2. Please, remember that the content of this document should be aligned with the risk management file and, if relevant, the use-related risk analysis.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.
All texts that are not blue are example texts that can and should be edited by you and tailored to your situation.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text updated to suit your situation.

 

Support

If you have questions about the template’s content, you may ask questions in the support forum. The support forum is accessible on this link when logged into your Medical Device HQ account.

 

Need usability engineering training and a course certificate?

We do our best to include instructions and example text needed for our templates. Nevertheless, if you want to learn more about usability engineering in general, the topic is covered in our public training courses: Introduction to Usability Engineering and IEC 62366-1 and Usability Engineering and IEC 62366-1 blended course. Our blended courses combine a self-paced online course first, followed by a live virtual classroom session facilitated by an industry expert.

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