Medical

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The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered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

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

In an effort to remain current with new medical technologies, product safety standard IEC 60601-1 underwent another revision with the 2012 publication of Amendment 1.  More than 100 pages in length, Amendment 1 (Edition 3.1) introduces more than 20 new requirements and 60 modifications to existing requirements for medical devices. For manufacturers of medical electrical... Read More

IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets

The 3rd edition of IEC 60601, issued in 2005, is in various states of adoption by regulatory bodies around the world.  IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries.  Unlike 2nd edition, the 3rd edition requires a risk management file and process conforming to ISO... Read More

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