Jon, If you look at Sec. 18.101 Basis and purpose, part 18 only applies to "medical equipment that emits electromagnetic energy on frequencies within the radio frequency spectrum in order to prevent harmful interference to authorized radio communication services." The Ultrasound equipment that I am familiar with does not emit electromagnetic energy that would cause interference. They also comply with CISPR 11 class A or B emissions requirements depending on where they are used. Do you certify your Ultrasound equipment to Part 18?
Best regards, Jim -----Original Message----- From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Jon Griver Sent: Monday, October 29, 2001 8:20 AM To: emc-p...@majordomo.ieee.org Subject: FW: FDA & FCC 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: owner-emc-p...@majordomo.ieee.org > [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Jon Griver > Sent: Sunday, October 28, 2001 2:07 AM > To: emc-p...@majordomo.ieee.org > 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 > > ndev...@entela.com e-mail > > > > > > > > > > > > -----Original Message----- > > From: am...@westin-emission.no [mailto:am...@westin-emission.no] > > Sent: Friday, October 26, 2001 5:15 AM > > To: emc-p...@majordomo.ieee.org > > 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: > > 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. > > > > ------------------------------------------- > > 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. > > > > > ------------------------------------------- > 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. > > > ------------------------------------------- > 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. > ------------------------------------------- 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. ------------------------------------------- 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.
