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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).
| Author | ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 1 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics
|
| Number of pages | 10 |
| Weight(kg.) | 0.1170 |
| Year | 2016 |
| Country | Switzerland |