ISO International Standard

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.