John, In the United States, the FDA regulates medical devices. The following link will gives you information on the FDA's approach to EMC:
http://www.fda.gov/cdrh/emc/ Although IEC 60601-1-2 is a 'concensus standard', FDA investigators sometimes have different or additional requirements. I have even known cases of demands for compliance with military immunity standards. The FDA writes the following: "This standard should serve as a baseline for all of the appropriate device areas. However, where there are existing CDRH guidance documents with additional EMC specifications then these will supersede the basic IEC requirements." Note that you will need UL 2601-1, but for product safety, not EMC. The reference to electrostatic charges in clause 39.3, which you found, is in regard to the risk of explosion of anaesthetic gases! This standard, or the international version, IEC 60601-1, covers electrical, mechanical and other safety aspects of medical electrical products. You may also find EMC requirements in the standards for particular types of medical equipment. These are numbered IEC 60601-2- XX, and you can see a list of them at: http://www.601help.com/Other_601_Standards/other_601_standards.html These EMC requirements may amend the requirements in IEC 60601-1-2 and will always be in clause 36 of these standards. Also note that in the US, medical equipment which intentionally uses EM radiation (e.g. microwave therapy devices), as well as ultrasound equipment, is required to comply with FCC Part 18, for ISM equipment. For the European Union, the EMC requirements are EN 60601-1-2, plus any EMC requirements of EN 60601-2-XX. (The EN version is usually almost identical to the IEC version). However, you should note that at the moment the 1993 version of the standard is in effect, not the 2001 version! Presumably the 2001 version will come into effect at some point in the future. You can see a list of all the Medical Device Directive harmonised standards at: http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html (If this wraps to two lines, you may have to enter the second line manually) A further note about IEC or EN 60601-1-2. It is a 'pointing' standard, in that it refers to and provides test levels for EN 55011 for emissions and IEC 61000-4-X for immunity. These latter standards basically provide test methods for different EMC phenomena. Regards, Jon Griver www.601help.com The Medical Device Designer's Guide to IEC 60601-1 ******************************************************************** 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. 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