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AAMI EC13

2nd Edition, January 1, 2002

Complete Document

Cardiac monitors, heart rate meters, and alarms

Includes all amendments and changes through Reaffirmation Notice , 2007


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Superseded By: AAMI 60601-2-27

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W/D S/S BY AAMI 60601-2-27
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Description / Abstract:

This standard establishes minimum safety and performance requirements for electrocardiograph (ECG) heart rate and waveform monitors that are intended for use under the operating conditions specified in this standard. Subject to this standard are all parts of such monitors necessary to:

a) obtain a heart rate indication via noninvasive ECG sensing from the patient’s body;

b) amplify and transmit this signal and display the heart rate and/or ECG waveform; and

c) provide alarms, based on adjustable alarm criteria, upon the sustained occurrence of the following ratedependent phenomena: cardiac standstill, bradycardia, and/or tachycardia.

NOTE-The safety and performance criteria defined in this standard are intended principally for use in design qualification or “type” evaluation by the manufacturer. (Type evaluation is the full battery of tests that must be done on a typical instrument or group of typical instruments to verify that all performance design requirements have been met. It is used to officially establish that a product model’s design has achieved compliance with all standards to which a manufacturer claims compliance.)