Testing EEG, PSG and EMG input amplifiers for lead leakage per IEC 60601-2-26
JamesKnightRenownCSE
Reno, NV
in Hardware
I need to perform electrode lead leakage safety testing on EEGs, Electromyographs, and Polysomnographs. Does anyone use a tester for this or have you built one? I need to perform IEC 60601-2-26 Ed. 2.0 en:2002 Medical Electrical Equipment - Part 2-26: Particular Requirements For The Safety Of Electroencephalographs This doc pecifies the particular safety requirements for electroencephalographs, i.e. devices to produce an electroencephalogram. This Particular Standard amends and supplements IEC 60601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety as amended by its Amendment 1 (1991) and Amendment 2 (1995).
Comments
Hi James,
OpenBCI devices are not IEC 60601 (medically) certified. Because of the huge costs involved and limited market. Have you considered contacting other manufacturers who ARE certified? As you may know there are also specialty certification companies that shepherd manufacturers through the process.
https://www.google.com/search?q=iec+60601-1+certification
For example:
https://keystonecompliance.com/iec-60601-1/
https://f2labs.com/medical-devices-directive-testing
https://mpe-inc.com/iec-60601-medical-device-safety-standard/
Etc.
https://docs.openbci.com/FAQ/Liability/
[Disclaimer of medical, clinical, or diagnostic use]
William