Jim, Yes and no.
Yes. Medical ultrasound equipment is explicitly included in the scope of Part 18 under Section 18.107(f). I assume the logic is that RF circuits are required to generate the ultrasound. No. Section 18.121 excludes non-consumer medical ultrasound equipment, except for a few sections of Part 18 that deal mainly with allowed frequencies. Best Regards, Jon Griver http://www.601help.com - The Medical Device Developers' Guide to IEC 60601-1 > > 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. > ------------------------------------------- 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.
