EMC of Medical Devices - IEC 60601-1-2 Testing Standard

For North American manufacturers of medical equipment, the IEC 60601-1-2 standard adds immunity test requirements in addition to emissions per FCC Part 15 for commercial electronics. The EMC Shop supports manufacturers perform testing throughout the design process from component, to sub assembly to the final product. The test standard is readily available in PDF format across the internet. This will serve as your guide to generating a complete report for submission to the FDA.

IEC 60601-1-2 Compliance Testing

We prefer to start with developing what the (FDA recommends) is a clear electromagnetic immunity pass/fail criteria for their products and a clear statement of its Essential Performance. From there, we can work backwords to develop a test plan, start pre-compliance testing and redesign in preperation for accreditation.

Electromagnetic compatibility, means a medical device is compatible with (no interference is caused by) its electromagnetic environment and it does not emit levels of electromagnetic energy that cause electromagnetic interference in other devices in the vicinity. A medical device can be vulnerable to electromagnetic interference if the levels of electromagnetic energy in its environment exceed the electromagnetic immunity (resistance) to which the device was designed and tested. The different forms of electromagnetic energy that can cause electromagnetic interference are conducted, radiated, and electrostatic discharge. Electromagnetic interference problems with medical devices can be very complex, not only from the technical standpoint but also from the view of public health issues and solutions.