Standard: ISO - 18242
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS
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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).
|Organization:||International Organization for Standardization|
|Change Type:||NEW ADDITION|
|Most Recent Revision:||YES|