Avoid Failing Compliance Certification with a Design Partner Who Understands Medical Regulatory Changes

Posted on January 5, 2021 by Craig Myers

A company that develops medical products approached us with an all too common problem. They were required to test their medical device to the new IEC 60601-1-2, 4th Edition standards to maintain their compliance certification. But the device was designed prior to the latest revision of the 4th Edition on electromagnetic compatibility (EMC), and so it ultimately failed the new, more stringent requirements for electrostatic discharge (ESD) and radiated immunity.

We worked closely with SILENT Solutions LLC, an expert EMC consulting company and a DornerWorks’ partner, to identify the root cause of the certification test failures. SILENT Solutions LLC determined that the printed circuit board (PCB) layout was not conducive to proper emissions or immunity standards to pass the updated regulations. They created a report of the recommended countermeasures and submitted it to the company. The company then reached out to us for our expert hardware consulting services to perform the needed PCB design updates to address the report’s findings.

What caused the device to fail the IEC 60601-1-2, 4th Edition standard?

A screen capture of the microprocessor area of the PCB that had failed testing.

Upon inspection of the PCB layout that contained a microprocessor, we found several areas needing improvement in the power distribution network (PDN). There was also an opportunity for applying some EMC/EMI best practices that had not been implemented. Working closely with SILENT Solutions LLC, we designed a new PCB layout that maintained the size and form factor of the customer’s current device and fit into the existing mechanical enclosure. This minimized the cost of the changes required to pass the new testing.

How did we bring the design back up to the IEC 60601-1-2, 4th Edition standard?

The revised PCB layout with the EMC/EMI and ESD countermeasures implemented.

The DornerWorks design was built and tested for to verify functionality. Then the prototypes were sent to the customer for 4th Edition testing. The updated devices passed the testing of the revised standards on the first try and the customer was able to recertify the device by only updating the PCB. This further saved the customer money, as they could retain their product’s original mechanical housings and peripheral components (batteries, LCD displays, etc.) with zero modifications.

Thanks to the collaboration between DornerWorks and our partner, SILENT Solutions LLC, we were able to provide the customer with a quick, cost-effective solution to an increasingly common compliance problem. If this is a problem you’re facing today, we’d love to help you maintain your hardware compliance certification!

Schedule a meeting with us today to see how we can help you address your regulatory headaches.

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Craig Myers
by Craig Myers
Embedded Engineer
Craig Myers is an Embedded Engineer at DornerWorks.