Standard: AAMI EC12

DISPOSABLE ECG ELECTRODES

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Scope:

This standard establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring.

Inclusions

Included within the scope of this standard is any disposable ECG electrode system (see 3.4).

Exclusions

Devices excluded from the scope of this standard are active electrodes, needle electrodes, reusable (nondisposable) electrodes, electrodes intended to deliver therapeutic energy, and electrodes primarily designed for the measurement of physiologic signals other than the electrocardiogram (e.g., electrodes used with apnea monitors, if the electrode is used for non-ECG purposes, e.g., impedance plethysmography). Also, requirements for electrolyte composition are not covered by this standard.

 

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami ec12
Publish Date: 2000-01-01
Page Count: 21
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

This Standard References

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