Doug, You are really asking if the product is Type B (earthed applied part) or Type BF (isolated ground part) according the the classification of IEC 60601-1.
The answer is that some types of medical equipment must be Type BF or even Type CF (direct cardiac contact) according to the appropriate particular standard, IEC 60601-2-X. For many types of equipment it is left to the manufacturer to decide. Generally speaking the longer and more invasive the contact with the patient, the more likely that Type BF or CF is required. In particular, in situations where many medical instruments may be connected to the patient simutaneously, e.g. in the operating room or intensive care, there is a greater need for isolated patient applied parts. This is to prevent a fault in one device causing dangerous leakage currents through the patient to earth via another device. Regards, Jon Griver http://www.601help.com The Medical Device Developer's Guide to IEC 60601-1 One final question - if some product which uses 115/230vac mains power and if there is to be metal contact between that product and a patient in an operating room environment, is it a matter of accepted practice that the mfr can decide the metal is grounded/ungrounded or must it be grounded as dictated by some standard? Regards, Doug McKean ------------------------------------------- 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" ------- End of forwarded message ------- ------------------------------------------- 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"
