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AAMI 11658
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AAMI 11658 2012 Edition, January 1, 2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
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Description / Abstract:
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.
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.