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/
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