ISO - 11658
Cardiovascular implants and extracorporeal systems - Blood/ tissue contact surface modifications for extracorporeal perfusion systems
|Publication Date:||15 May 2012|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is applicable to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have modifications on the blood and tissue-contacting surfaces of the device.
The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.