Tag Archives: IEC 60601-1-2
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The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered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
Top 7 Questions about IEC 60601-1-2 4th Edition for EMC Testing of Medical Devices
This Compliance Today post is a follow up to last week’s post on IEC 60601-1 Edition 3.1. Are there safety benefits to the 3rd edition of IEC 60601-1-2 compared to the 2nd? The test levels required by both the 2nd and 3rd editions of IEC 60601-1-2 are the same. The main change was in clause... Read More
FDA Adds 4th edition of IEC 60601-1-2 to EMC Consensus Standards List
In July 2014, the FDA recognized the 4th edition of IEC 60601-1-2 as a standard that can be used to show EMC compliance for medical electrical devices and systems. The complete standard is recognized with the following exception: In Subclause 8.9, Table 8 on Page 39: The citation of Note b) under “Conducted disturbances induced... Read More
Top 10 Compliance Today Blog Posts for Electrical Compliance Engineers in 2014
Just like last year, the Compliance Today blog for electrical product manufacturer compliance engineers saw a significant increase in readers and subscribers for 2014. Following were the most popular posts, by pageviews. IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes EN 61326-1: 2013 Replacing 2006 Version for EMC Directive Evaluation... 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
