EMC for Medical and In Vitro Diagnostic Equipment
Watch this presentation to explore the recent changes to the medical EMC standard IEC 60601-1-2 and the IVD EMC standard IEC 61326-2-6.
THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Watch now: EMC for Medical and In Vitro Diagnostic Equipment
In healthcare applications, electromagnetic incompatibility can be potentially life-threatening. Most global regulatory bodies recognize that a product cannot be safe and effective if it is not compatible with its intended electromagnetic environment.
Webinar date: July 14, 2022
Speaker: Bob Delisi, principle engineer
Electromagnetic compatibility (EMC) for medical equipment and in vitro diagnostic (IVD) equipment
In this presentation, you can learn about:
- An overview of the recent changes to the medical EMC standard IEC 60601-1-2 and the IVD EMC standard IEC 61326-2-6. These changes not only impact testing but can also impact manufacturers’ responsibilities regarding these devices.
- Explore the applicability of the standards, changes and what information you need to provide to the EMC laboratory to support testing.
- Details on how the U.S. Food and Drug Administration (FDA) recognizes these standards for both medical and IVD devices.
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Related resources
Things to Know About IEC 60601-1 Amendment 2
The Difference Between a Medical and a Wellness Device
Wireless Module Compliance for Medical Devices
Medical Device Cybersecurity
Your Medical Device Is Smart, but Can It Connect?
Additional resources
Medical Device Performance and Safety Testing
Medical Device Regulatory Testing and Certification
IEC 60601: International Product Safety Standards for Medical Devices
Designing for Compliance to IEC 60601-1 3rd Ed.
Medical Device EMC Testing and Certification