Standard: AAMI EC13


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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.)

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami ec13
Publish Date: 2002-01-01
Page Count: 1
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: NO
Status: Inactive