John, Medical Electronics is tested for emc to:
EN/IEC 60601-1-2 This standard is accepted by the FDA which regulates medical equipment in the US. Good Luck in your testing. Peter Merguerian -----Original Message----- From: John Barnes To: [email protected] Sent: 8/9/02 11:58 PM Subject: EMC/EMI/ESD Requirements for Medical Electronics in US? EMC-PSTC'ers, Does the United States have any electromagnetic compatibility (EMC), electromagnetic interference (EMI), or electrostatic discharge (ESD) standards for medical electronics? If so, where can I find them? A prospective client has asked about EMC/EMI/ESD testing for a wearable medical-monitor. It looks like the applicable standards for Europe are: * EN 55011:1998 +Amendment A1:1999. * EN 60601-1-2:2001. I found some references on the Internet to: * The Food and Drug Administration using UL 2601-1 for medical devices. * UL 2601-1 having the same immunity requirements as EN 60601-1-2. Having been bitten by supposedly-identical standards being just a little different in areas critical to products I've designed, we bought UL2601-1 ($155 with shipping and handling), and received it yesterday. The cover letter is dated June 16,2000, and describes it as "Second Edition, Dated October 24, 1997". Section 39.2 has a couple of paragraphs about "Prevention of electrostatic charges". Appendix A1, section A1.5.2, says "The sensitivity of EQUIPMENT to external interference (electromagnetic field, perturbations of the supply voltage) is under consideration. Appendix L refers to IEC 601-1-2:1993. Is there a newer amendment to UL 2601-1 that has EMC/EMI/ESD requirements, or just what *do* people use to verify/certify medical electronics? Thanks! John Barnes dBi Corporation http://www.dbicorporation.com/ ------------------------------------------- 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: Ron Pickard: [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: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list" ------------------------------------------- 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: Ron Pickard: [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: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
