Use Specification Template (IEC 62366-1, Medical Device)

Description

Why it is useful

A use specification is required to demonstrate that the usability engineering process, as required by IEC 62366-1:2015 + AMD:2020, has been followed and to provide evidence that acceptable risk related to the usability of the medical device is ensured. The use specification is the foundation for all further usability engineering activities and their documentation.

How to use it

1. The use specification document provides input to the implementation of the requirements in 5.2 of ISO 14971:2019.
2. If you are developing a brand-new product, establish as much as possible of the use specification in the planning phase of your project.
3. If you are changing the intended purpose/use of a previous product, update this use specification accordingly.

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. Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customized to work with the current project.

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.