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.
Status: PublishedPublication date: 2012-05
Edition: 1Number of pages: 6
Technical Committee: ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
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