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The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered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