Published
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).
PUBLISHED
ISO 18242:2016
90.93
Standard confirmed
Aug 1, 2023
PUBLISHED
ISO 18242:2016/Amd 1:2023
Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps
60.60 Standard published
Shqip