Transition to IEC 60601 4th Edition - Risk Analysis and test submissions

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
We need to create a Risk Analysis and then a test plan, execute the test and create a report and submit this to our NB. Assuming we test at max levels for the 4th Edition of IEC 60601 is there a reason the NB could reject our report?


Staff member
Super Moderator
Well, there's always a reason they COULD reject your report! :)

Is the question whether you can do the work to demonstrate compliance to 60601 versus having a test lab do it? The short answer is yes, you can do it; however, if not done by an accredited lab then they will likely charge you more for review time and lengthen the review to scrutinize the data and ensure it meets the same criteria as an accredited lab would provide.

If that wasn't the gist of your question, please clarify.


Involved In Discussions
The other thing to ensure when you write your test plan is that the equipment is operating properly and is being properly monitored - just "throwing" test levels at a device isn't sufficient if its performance is not being properly monitored during the tests

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