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Description / Abstract:
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.
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.