scope:

This standard covers TRUNK CABLES and PATIENT LEADWIRES used to acquire surface electrocardiographic (ECG) monitoring signals for cardiac monitors/telemetry transmitters (ANSI/AAMI/IEC 60601-2-27), diagnostic electrocardiographs (ANSI/AAMI/IEC 60601-2-25) and ambulatory ECG recorders/event recorders (ANSI/AAMI/IEC 60601-2-47). In the broadest sense, this standard applies to any ECG DEVICE that uses PATIENT LEADWIRES and possibly ECG TRUNK CABLES to acquire surface electrocardiographic signals.

This standard covers both disposable and reusable PATIENT LEADWIRES as well as TRUNK CABLES (generally considered to be reusable). The concept of "disposable" applies to products intended to be used for a single PATIENT stay, typically up to 7 days (SINGLE-PATIENT USE) as well as to products intended to be used one time, typically a few hours (SINGLE USE). For terminological consistency, the concept of "reusable" is referred to as MULTI-PATIENT USE.

Some PATIENT LEADWIRES and TRUNK CABLES used for recording applications might not be intended to be DEFIBRILLATOR-PROOF, but otherwise must meet all the requirements in this standard. Such PATIENT LEADWIRES and TRUNK CABLES are included within the scope of this standard but must be clearly labelled as not being DEFIBRILLATOR-PROOF.

The tests in this standard allow MANUFACTURERS to verify compliance of their products to this standard's specifications. These tests are not intended to be performed by OPERATORS or RESPONSIBLE ORGANIZATIONS.

ECG TRUNK CABLES and PATIENT LEADWIRES used in applications that require special characteristics, such as a magnetic resonance imaging (MRI) suite, are excluded from this standard. TRUNK CABLES and PATIENT LEADWIRES covered by this standard might support physiologic functions in addition to ECG monitoring, such as respiration monitoring by impedance pneumography. However, the TRUNK CABLE and PATIENT LEADWIRES must meet all of the requirements of this standard, unless a requirement is specifically excluded.