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ANSI/AAMI DF80:2003 (R2010)

Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators(including automated external defibrillators)

This standard specifies requirements for the safety of medical electrical equipment intended to defibrillate the heart by an electrical pulse via electrodes applied either to the patient's skin (external electrodes) or to the exposed heart (internal electrodes). This standard does not apply to implantable defibrillators, remote control defibrillators, or separate cardiac monitors.

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Association for the Advancement of Medical Instrumentation [aami]

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