Power Supply Requirements for Medical Applications

[yura717]

Medical device has electrical contact with patent's skin ... What are requirements for power supply in this case?

 

[bigdogguru]

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