ISO 18242:2016

Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps

ISO 18242:2016 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.

It does not apply to

– centrifugal pumps used as ventricular assist devices, and

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

Edition	2016
Published Date	2016
Published By	International Standardization Organisation
Page Count	10