Hi Kevin, Hospitals are generally considered Class A. If the device will be used in the OR, you should also consider ESU testing even thought it is not specifically mentioned (at this time) in standards you mentioned below. Your customers in the OR will be real unhappy when the Bovie goes off and your product fails to function.
Best regards, Jim -----Original Message----- From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Kevin Hight Sent: Monday, February 11, 2002 11:16 AM To: emc-p...@majordomo.ieee.org Subject: Medical Device Emissions Limit? Good Morning, I am in desperate need of your expert assistance. I need to define the requirements for a device that is located in a hospital operating room. Device 'X' is used during surgery and makes contact to the patient. The device will be compliant with EN 60601-1, EN 60601-1-1, & EN 60601-1-2 (2001). Question: For Radiated Emissions, is this product a Class A or a Class B device? Regards, ______________________________________________________ Kevin J. Hight - Principal Compliance Engineer Colorado MEDtech, Inc. 6175 Longbow Drive, Boulder, Colorado 80301 Phone: (303) 530-8288 x-3111 Fax: (303) 581-1003 Email: k...@cmed.com <mailto:k...@cmed.com> http://www.cmed.com <http://www.cmed.com> "Great crises produce great men, and great deeds of courage." -- John F. Kennedy ------------------------------------------- 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: Ron Pickard: emc-p...@hypercom.com 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: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list" ------------------------------------------- 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: Ron Pickard: emc-p...@hypercom.com 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: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
