This standard establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. Section 5.3.2 conflicts with an existing regulation, see Section 898.12 Performance standard listed below. Section 5.3.2 conflicts with existing final published guidance, see Section 5 Performance Characteristics listed below. Section 5.3.2 conflicts with another recognized standard, see ANSI/AAMI EC53 listed below.