Use specification template

Use specification Template

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This template will provide you with a framework to complete the use specification.

It may also be used as a benchmark on your existing use specification. The template includes topics required by clause 5.1 of IEC 62366-1:2015 + AMD:2020.

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.

Learn More

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. 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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Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course. These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.