Medical

OSHA Close to Authorizing NRTL Certification to ANSI/AAMI ES60601-1 for Medical Equipment

After a long wait, medical electrical equipment manufacturers are looking forward to the Occupational Safety & Health Administration’s (OSHA) expected near-term recognition of one or more labs – including MET Labs – for product safety certifying medical devices to ANSI/AAMI ES60601-1:2005/(R)2012 under the U.S. Nationally Recognized Testing Laboratory (NRTL) Program. In March 2014, OSHA announced... 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

New Medical Equipment Safety of Interoperability Standard AAMI/UL 2800 Being Developed

This week, MET’s Product Safety Lab Director Rick Cooper is attending a meeting of a newly-convened standards committee in Long Beach, CA to discuss the creation of a new medical equipment safety of interoperability standard(s) tentatively known as AAMI/UL 2800. The meeting is well attended by interested parties consisting of certification agencies like MET Labs,... Read More

Medical Product Safety Training Yields Insight on IEC 60601-1 3rd Edition

MET Laboratories’ product safety engineers undergo regular training to stay up-to-date with changing standards and regulatory requirements.  When possible, we will share highlights of these sessions with customers. Following are some of the key points of a recent training session on IEC 60601-1 3rd edition: It is an entirely new standard and does not match... Read More