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Frequently Asked Questions about IEC 60601 for Custom Medical Carts

Posted by Brittany Beckmann on March 23, 2017

Almost everybody involved in the medical device industry has heard of 60601. However, that doesn’t necessarily mean everyone knows what it is.

And that’s OK!

We’ve taken the liberty of breaking down IEC 60601-1 3rd edition by answering a few frequently asked questions about IEC 60601 for custom medical carts. In addition to this, we’re also going to implement a series of DIY (Do It Yourself) 60601-1 testing posts, which will define a standard clause, the reasoning for it and how you can put your product to the test.

Please note that this will NOT mean your custom medical cart will be 60601 certified. Only a testing lab with IEC 60601-1 3rd edition certifications—like MECA—can actually grant that certification. This series will give you an inside look at 60601 testing and the opportunity to test your product before sending it to a lab to ensure it passes.    

 

IEC 60601-1 3rd Edition: More Than Just a Buzz Word  

IEC 60601-1 3rd edition pertains to a series of technical standards for medical electrical equipment, which is instated for safety and effectiveness. In layman’s terms: it’s a series of tests that ensure the safety of your product. Safety features that are taken into account include sharp edges, pinch points, how it handles leaning, possibility of tipping and broaching thresholds.

 

Does my custom medical cart manufacturer need to be IEC 60601-1 certified?

Short answer: no.

However, you will want to invest in a custom medical cart specialist or manufacturer that has an intimate knowledge of 60601-1 practices and understands how to design to that standard. It’s even better if you form a partnership with a company that collaborates with an IEC 60601-1 certified lab.

 

Do I need IEC 60601-1?

This is where it gets a little hairy. First of all, is IEC 60601-1 3rd edition something your regulatory requires? Is there an electrical risk associated with your product? Discuss this at length with your manufacturer and R&D engineer. You can also read our past blog for a little more clarity on this topic.  

 

When does this come up in the custom medical cart process?

Address this at the beginning of the project with all your regulatory people because 60601 will affect design, budget and lead time. The actual testing process takes place after engineering and typically lasts anywhere between 8-10 weeks. Keep in mind that this timeline may vary depending on whether or not electrical tests are necessary.

 

What will this cost me?

The cost of 60601 testing will depend on a myriad of variables like the extent of testing required, documentation, method sense—risk management files. The IEC 60601-1 3rd edition tests applicable to your custom medical cart can cost anywhere from 10K $20K. Most manufacturers will encourage their customers to hold their own file and fees associated with 60601.

 

Now that we’ve covered the basics of IEC 60601-1 3rd edition, check in with us for a new DIY video and blog for these standard 60601-1 3rd edition tests.

 

At HUI, our custom medical cart team has an intimate knowledge of IEC 60601-1 3rd edition and how to design to that standard. If you have any questions regarding 60601, have a video request or have a custom medical project in mind, comment below or contact us today.

HUI 60601-1 Third Edition Cheat Sheet

Topics: IEC 60601-1


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