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AAMI TIR61

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AAMI TIR61 2014 Edition, January 1, 2014 Generating reports for human factors design validation results for external cardiac defibrillators

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Description / Abstract: This Technical Information Report (TIR) applies to the human factors design of external cardiac defibrillators, as covered by ANSI/AAMI/IEC 60601-2-4:2010, Medical electrical equipment – Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators. The guidance provided by this TIR is intended to be applicable to all external cardiac defibrillator/monitors, and automated external defibrillators (AEDs) including public access defibrillators (PADs).