Paul, Medical equipment is exempted from Part 15, but certain medical equipment which intentionally uses RF (microwave equipment, ultrasound equipment, etc.) is subject to Part 18. HOWEVER, medical equipment in the US is subject to FDA regulations, and the FDA does have EMC requirements for medical equipment. IEC 60601-1-2, the EMC standard for medical equipment (covering both emissions and immunity) is an FDA 'consensus' standard, and the FDA generally requires that medical equipment complies with this, though they sometimes have different and/or additional requirements.
The EU's Medical Devices Directive also requires compliance with IEC 60601-1-2. Regards, Jon Griver http://www.601help.com The Medical Device Developer's Guide to IEC 60601-1 ----- Original Message ----- From: "Paul Lovell" <[email protected]> To: <[email protected]> Sent: Tuesday, October 11, 2005 6:08 PM Subject: FCC Part 18 > Paul Lovell > Group Compliance Manager > Huntleigh Healthcare > Tel: +44 (0)1582 745891 > > Hi All, > > I understand that Part 18 applies to ISM products but what is its current > status (ie active or waived)? Is it just EMC or does it cover other > things? > > > Please excuse my ignorance, I'm new to the medical field, but I'm told > there > are no FCC emissions requirements for medical devices, something which > surprised me given how much effort goes into complying with Part 15 in the > IT field. > > Best regards, > > Paul Lovell > Group Compliance Manager > Huntleigh Healthcare > > Tel: +44 (0)1582 745891 > > The information contained in this electronic mail, including all > attachments are intended only for the personal use of the designated > recipient named and is confidential and may also contain privileged > company information or work product. The information is intended only for > the use of the individual, individuals, or entity to whom the electronic > mail is addressed. If you are not the intended recipient, or agent > responsible to deliver it to the intended recipient, you are hereby > notified that any use, dissemination, distribution or copying of this > communication is strictly prohibited. If you have received this electronic > mail in error, please return to us immediately. Thank you > > This email has been scanned on behalf of Huntleigh Technology PLC for all > viruses by the MessageLabs SkyScan service. > > - > ---------------------------------------------------------------- > This message is from the IEEE Product Safety Engineering Society > emc-pstc discussion list. Website: http://www.ieee-pses.org/ > > To post a message to the list, send your e-mail to [email protected] > > Instructions: http://listserv.ieee.org/listserv/request/user-guide.html > > List rules: http://www.ieee-pses.org/listrules.html > > For help, send mail to the list administrators: > > Scott Douglas [email protected] > Mike Cantwell [email protected] > > For policy questions, send mail to: > > Jim Bacher: [email protected] > David Heald: [email protected] > > All emc-pstc postings are archived and searchable on the web at: > > http://www.ieeecommunities.org/emc-pstc > > > -- > No virus found in this incoming message. > Checked by AVG Anti-Virus. > Version: 7.0.344 / Virus Database: 267.11.14/128 - Release Date: > 10/10/2005 > > - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
