Tag Archives: risk analysis
IEC/EN/UL/CSA 61010-1 Third Edition
Since the release of the 3rd Edition, there have been varying interpretations regarding if and when a Risk Assessment is a requirement or merely an option. The disagreements have occurred between different Certification Bodies, between test houses and manufacturers, and even within specific discrete entities. Given this previous uncertainty and the possibility of inconsistently imposed... Read More
IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes
In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. There are a number of changes in the 4th edition, including new immunity and risk analysis requirements. Dates For new products in the U.S., the FDA will make a decision on the 4th edition this July, with a likely 3-year transition period... 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
