scope:

This document specifies requirements for sterile, single-use, extracorporeal centrifugal blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-assisted venous drainage, or extracorporeal membrane oxygenation.

This document does not apply to

- centrifugal pumps used as ventricular assist devices, and

- other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).