Actually it sounds like you'll be subject to the Medical Device directive, which does contain emission and immunity requirements. Check out En60601-1-2.
The FCC does not have immunity or emission requirements for medical equipment except for part 18 ISM equipment. But yes the FDA may inquire as to product compliance with certain immunity standards. The FDA could also inquire as to product immunity to magnetic fields. The MRI manufacturers are required to document distance vs magnetic field strength of the magnet. This could affect your installation specification. For example, you may want to be outside the 5 gauss line. -----Original Message----- From: [email protected] <[email protected]> To: undisclosed-recipients:; <undisclosed-recipients:;> List-Post: [email protected] Date: Saturday, March 13, 1999 12:10 PM Subject: EMC for a medical device >Hello everyone, > >I have a new device intended to be operated near an MRI machine. The market is initially the >US. >(Eventually I guess I will be subject to CE EMC directive) > >Does the FCC have any EMC (emissions) requirements in this case? (or is the device exempt just > >because it is a medical device?) >I guess immunity would be mandated by FDA requirements (?) > >Are there any functional EMC issues related to the high magnetic fields in that area? > > >thanks, >Moshe >-------------------------------------------- >Name: moshe valdman >E-mail: [email protected] >Phone: 972-52-941200 >Telefax: 972-3-5496369 >Date: 13/3/99 >Time: 17:51:37 >You are most welcome to visit my homepage at: > >http://www.geocities.com/CapeCanaveral/5233/ >-------------------------------------------- > > > >--------- >This message is coming from the emc-pstc discussion list. >To cancel your subscription, send mail to [email protected] >with the single line: "unsubscribe emc-pstc" (without the >quotes). For help, send mail to [email protected], >[email protected], [email protected], or >[email protected] (the list administrators). > > --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], [email protected], or [email protected] (the list administrators).
