Template: Usability Evaluation Protocol

Dr. Oliver Eidel IEC 62366 Templates Published June 09, 2022

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Usability Evaluation Protocol

Mapping of Standard Requirements to Document Sections

IEC 62366-1:2015 Section Title Document Section
4.2 Usability Engineering File (all)
4.3 Tailoring of the Usability Engineering effort (all)

1. User Group and Environment

Describe the user group here, e.g., physicians with experience in a certain field.

Also, describe the environment in which the user test is being conducted. Obviously, both the user group and
environment should match whatever you described in your Intended Use. So, if your app is intended to be used
by emergency physicians in a brightly-lit hospital environment, you should also have these people do the
usability test in a similar environment.

2. Preparation

Describe whether you prepare users in any way. Again, this should be based on the use context in which your
users will be using your device in real life. So, if people typically carefully read the user manual before
(not sure in which parallel universe that happens), you can give them the manual and some time to study
it. More realistically, you'll probably test how users handle your device when they haven't read the manual.

If there are official training which are required before users can use your device, you should do this
training first, of course.

3. List of Tasks

This table lists the tasks you want your users to perform. It's kind of the master table which will be
copy-pasted for each user below - you'll be filling out the observations and hazards encountered by each
user.

As always, using a spreadsheet (e.g., Google Sheets) instead of a document is a very good idea here.

ID Description App State / Environment Instructions Acceptance Criteria Observations Hazards encountered

4. Protocols

Copy-paste the table above for each user and fill it out during the test. Note down the names and ages (or
any other important characteristics) per user.

User 1 (Name, Age)

ID Description App State / Environment Instructions Acceptance Criteria Observations Hazards encountered

User 2 (Name, Age)

ID Description App State / Environment Instructions Acceptance Criteria Observations Hazards encountered

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Dr. Oliver Eidel avatar

Dr. Oliver Eidel

I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.

Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you’re still lost and have further questions, reach out any time!