Tag Archives: IEC 60601-1-2

FDA Issues Guidance on EMC of Electrically-Powered Medical Devices

The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered products for premarket submissions. Typically, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of... Read More

Top 10 Compliance Today Blog Posts for Electrical Compliance Engineers in 2014

Just like last year, the Compliance Today blog for electrical product manufacturer compliance engineers saw a significant increase in readers and subscribers for 2014. Following were the most popular posts, by pageviews. IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes EN 61326-1: 2013 Replacing 2006 Version for EMC Directive Evaluation... Read More

FDA Issues Guidance for Integration of RF Wireless Technology in Medical Devices

Due to rapid growth in medical devices that incorporate RF wireless technology, on August 14 the Food and Drug Administration (FDA) released final guidance for integrating radio frequency (RF) wireless technology in medical devices.  The guidance is recommended, but not mandatory. FDA said its recommendations cover devices that are implanted or worn on the body, and... Read More