Hi, I need some help from the EMC experts.
According to FDA Acting Chief of the Brach I am dealing with, since the FDA has recognized IEC 60601-1-2 Second Edition (October 2001), then "...If they submit a new 510(k) (or even a modification for an existing device) and we have recognized the more recent standard, then they would need to comply with the new standard." Making the new edition immediately effective seems a little harsh. I am appealing his interpretation, but I don't know if I will have any luck. Has anyone had any success in doing a risk analysis to use lower immunity compliance levels than specified in IEC 60601-1-2, Second Edition, Section 36.202.1 a) or using different compliance criteria (36.202.1 j))? Or does Clause 6.8.3.201 a) 5), "These justification shall be based only on physical, technological or physiological limitations..." pretty much preclude the use of lower limits? The device in question meets IEC 60601-1-2 First Edition, but will not pass the requirements in the Second Edition. Can the "justification" be that since there are no known risks on the device, the current level of immunity is adequate? Thanks Ned Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: pstc_ad...@garretson.org Dave Heald davehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server.
