ISO DIS 18242

Description / Abstract: This International Standard 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 venovenous bypass, kinetic-assisted venous drainage, or extracorporeal membrane oxygenation.

This International Standard does not apply to:

- centrifugal pumps used as ventricular assist devices;

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