Oct 23, 2013 #1 yura717 Advanced Member level 2 Joined Aug 24, 2009 Messages 692 Helped 90 Reputation 178 Reaction score 89 Trophy points 1,308 Location USA Activity points 4,607 Medical device has electrical contact with patent's skin ... What are requirements for power supply in this case?
Medical device has electrical contact with patent's skin ... What are requirements for power supply in this case?
Oct 23, 2013 #2 bigdogguru Administrator Joined Mar 12, 2010 Messages 9,821 Helped 2,350 Reputation 4,694 Reaction score 2,272 Trophy points 1,413 Location Southwest, USA Activity points 62,383 Are you referring to a device like an ECG? As far as devices permitted in the US market, I believe such devices must adhere to the ANSI/AAMI ES-1, IEC 601-1 and EC11 Electrical Standards. The FDA actually provides documentation as to what standards such devices must adhere, for example: Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement) Once you have the required standards, you can then search for comprehensive documentation pertaining to those particular standards, for example: ANSI/AAMI ES1-1993, "Safe current limits for electromedical apparatus Some of the more recent ISO standard documentation, must be purchased and they can be quite expensive. BigDog
Are you referring to a device like an ECG? As far as devices permitted in the US market, I believe such devices must adhere to the ANSI/AAMI ES-1, IEC 601-1 and EC11 Electrical Standards. The FDA actually provides documentation as to what standards such devices must adhere, for example: Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement) Once you have the required standards, you can then search for comprehensive documentation pertaining to those particular standards, for example: ANSI/AAMI ES1-1993, "Safe current limits for electromedical apparatus Some of the more recent ISO standard documentation, must be purchased and they can be quite expensive. BigDog