Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables

摘要

The Food and Drug Administration (FDA) is issuing a final rule establishing a performance standard for electrode lead wires and patient cables. The agency is taking this action because it has determined that a performance standard is needed to prevent electrical connections between patients and electrical power sources. The final rule will substantially reduce the risk of electrocution from unprotected electrode lead wires and patient cables.