<p>This International Standard specifies requirements for the physical, biological and performance testing of</p>
<p>biocompatible modifications on extracorporeal devices. This International Standard is applicable to components</p>
<p>of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have</p>
<p>modifications on the blood and tissue-contacting surfaces of the device.</p>
<p>The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If</p>
<p>hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.</p>
Registration number (WIID)
50659
Scope
<p>This International Standard specifies requirements for the physical, biological and performance testing of</p>
<p>biocompatible modifications on extracorporeal devices. This International Standard is applicable to components</p>
<p>of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have</p>
<p>modifications on the blood and tissue-contacting surfaces of the device.</p>
<p>The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If</p>
<p>hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.</p>
