Tag Archives: medical testing

Top 10 Compliance Today Blog Posts for Electrical Compliance Engineers in 2015

EMC, Product Safety, Wireless

Each year we see a significant rise in readers and subscribers for our Compliance Today Blog posts. The following were the most viewed posts in 2015. ETSI EN 300 328 Version 1.9.1 Contains Important Updates to V1.8.1 FCC Incorporates ANSI C63.4-2014 and ANSI C63.10-2013 into Rules for Unintentional and Intentional Radiators External Power Supplies Must... Read More

FDA Issues Guidance on EMC of Electrically-Powered Medical Devices

EMC, Medical

The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered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

IEC 60601-1 Edition 3.1 Introduces New Product Safety Requirements for Medical Electrical Equipment

Medical

IEC 60601-1 Third Edition Amendment 1 (Ed. 3.1) What you need to know For manufacturers of medical electrical equipment and systems, IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding... Read More