Fueled by the drive for lower cost and better patient experiences and outcomes, modern image guided therapy systems are optimized for clinical workflow. This requires system architectures and designs that are highly configurable and are able to operate reliably and safely in rapid growing complex electro-magnetic environments. The 4th edition of the medical EMC standard was published in 2014 and will become mandatory from Jan 1st, 2019. Disturbance levels for immunity testing have been significantly increased and the concept of EMC risk management has been introduced. At the same time regulatory requirements for medical devices are reinforced in various regions in the world, that have not (yet) harmonized to the latest version of the EMC standard. How did we manage to keep this technical and regulatory complexity in control for large medical system families for which the ‘conventional’ EMC lab testing time already exceeded 100 test days?
Rob Kleihorst, Philips Healthcare