Jon, Ultrasound equipment does us use RF directly to treat or diagnose patients. I don't believe Ultrasound equipment falls under part 18.
The FDA is now recommending the use of IEC 60601-1-2; 2001 for EMC. Best regards, Jim -----Original Message----- From: [email protected] [mailto:[email protected]]On Behalf Of Jon Griver Sent: Sunday, October 28, 2001 2:07 AM To: [email protected] Subject: FDA & FCC This is not quite the whole story. Medical devices must get FDA approval, including EMC aspects. However, medical equipment is also subject to FCC regulations. FCC Part 15 exempts medical equipment (Sec 15.103), though it is still subject to the general requirements of the FCC in that devices found to cause interference can be stopped from operating. Medical devices that intentionally use EM radiation are subject to FCC Part 18. This includes ultrasound equipment, diathermy equipment, microwave therapeutic devices. Regards, Jon Griver http://www.601help.com - The Medical Device Developers' Guide to IEC 60601-1 > > Hi, > > In the USA, it is the FDA. For most medical products, the FDA determines > that your product is Substantially Equivalent to a legally > marketed device. > This is the FDA 510(k) process. They issue you a letter that > allows you to > legally market the device. > > For EMC, the FDA usually wants to see that you comply with IEC > 60601-1-2. > > Ned > > > Ned Devine > Program Manager III > Entela, Inc. > 3033 Madison Ave. SE > Grand Rapids, MI 49548 > > 616 248 9671 Phone > 616 574 9752 Fax > [email protected] e-mail > > > > > > -----Original Message----- > From: [email protected] [mailto:[email protected]] > Sent: Friday, October 26, 2001 5:15 AM > To: [email protected] > Subject: FDA > > > > 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. > ------------------------------------------- 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.
