Not a dumb question at all, the FDA sets performance for medical equipment and that includes EMC performance. My understanding at the present time is that requirements are a smorgasbord of commercial (CE/RE) and platform style (CI/RI) requirements. By platform I mean tests derived for equipments which mount on metal vehicles with ground planes. For instance I believe one CI requirement is akin to MIL-STD-461E CS114, swept frequency bulk cable injection.
---------- >From: <[email protected]> >To: <[email protected]> >Subject: FDA >Date: Fri, Oct 26, 2001, 4:15 AM > > > Hi all, > > What is the basic differences between FDA and FCC ? Don't laugh, yes I know > it is a silly question, but if you want to certify medical equipment, are > the requirements covered in the FDA or in the FCC regulations ? > > As you understand, within this field, I'm a really novice ........... > > Best regards > Amund Westin, Oslo/Norway > > > > ------------------------------------------- > 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: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Michael Garretson: [email protected] > Dave Heald [email protected] > > For policy questions, send mail to: > Richard Nute: [email protected] > Jim Bacher: [email protected] > > 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. > ------------------------------------------- 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: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] 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.
