AAMI EC12

Disposable ECG electrodes

: AAMI

: 2220000016212

: true

true
$175.00
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Publication Date: 01/01/2000 - Complete Document Changes Incorporated *

Description :

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.

 

Document Type : Complete Document

Edition : FDA RECOGNIZED

Language : English

Page Count : 21

Publication Date : 01/01/2000

Revision : 00

Status : Current

Supplement : W/

Title : Disposable ECG electrodes