Tag Archives: AAMI
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
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