Tag Archives: emc testing

FAQ: Risk Management for IEC 60601-1

FAQ: Risk Management for IEC 60601-1 What you need to know about Risk Management for medical devices What is Risk Management in 60601? Risk management is a series of risk evaluations performed by the manufacturer, based on ISO 14971, which are undertaken and documented throughout the design, production and post-production process of medical equipment. The... Read More

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The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered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

Gulf Countries Introduce GCC Certification for Safety & EMC of Low Voltage Electrical Equipment

The Gulf Cooperation Council (GCC) Standardization Organization (GSO) has introduced a common Technical Regulation for low voltage electrical products, effective July 1, 2016. This Technical Regulation (BD-142004-01) covers safety and electromagnetic compatibility and will affect seven GCC member states: Saudi Arabia, UAE, Kuwait, Bahrain, Qatar, Oman and Yemen.  It follows a similar existing regulation for... 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