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
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
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
Health Canada Provides Guidance on IEC 60601-1 3rd Edition Transition
For Medical Electrical Equipment product safety compliance in Canada, Health Canada currently recognizes both the second edition of IEC 60601-1, published in 1988, and the third edition, published in 2005. In October, 2008, Health Canada published a notice indicating that until June 1, 2012, conformity to the second edition of IEC 60601-1 and its related... Read More
60601-1 Third Edition Overview Covers Key Changes from Second Edition
This Compliance Today blog post is derived from the second half of a MET Labs-hosted 60601-1 3rd Edition Overview webinar. Find the transcription of the first half of the webinar here, or the full recorded webinar here. Following are the key changes from the 2nd to 3rd edition of 60601-1 for electro-medical device product safety... Read More
60601-1 Third Edition Overview Outlines Adoption in U.S., Canada & EU
Last week, MET Labs hosted a 60601-1 Third Edition Overview webinar. The webinar was very popular, so we are following up with a transcription of many of the key points. About half of the presentation was devoted to regional acceptance. United States In the U.S., the current standard is UL 60601-1 First Edition, with revisions... 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
IEC 60601-1 3rd Edition Challenges Medical Products Industry
Rarely has a standard change elicited as much confusion – and anguish – as the transition to the third edition of 60601-1. Much of the confusion surrounds the varying rates of adoption of the new edition in different countries and regions. Here is a basic primer: IECEE CB Scheme – Issued in 2005, IEC 60601-1... Read More
