scope:

This standard covers cables and patient leadwires used for surface electrocardiographic (ECG) monitoring in cardiac monitors as defined in ANSI/AAMI EC13-1992, Cardiac monitors, heart rate meters, and alarms.

Inclusions

This standard covers both disposable and reusable leadwires, with certain sections of the standard applicable to both, and certain sections applicable only to one (applicability is marked on appropriate sections after the section title in the following manner: "BOTH," "DISPOSABLE," or "REUSABLE").

The tests in this standard are designed to enable manufacturers to verify compliance of their products to the safety and performance specifications contained herein. These tests are not intended to be performed by device end users.

This standard defines a safe (no exposed metal pins) common interface at the cable yoke and leadwire connector.

Exclusions

ECG cables and leadwires that are used in applications that may require special characteristics, such as ambulatory ECG devices, telemetry units, the operating room and the cardiac catheterization lab, are excluded from this standard. The cables and patient leadwires included in this standard may supply other functions in addition to ECG monitoring, such as respiration monitoring by impedance pneumography. However, the cable and patient leadwires must meet all of the requirements of this standard, unless a requirement is specifically excluded.