This standard was last reviewed and confirmed in 2017. Therefore this version remains current.
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:Cardiovascular implants and extracorporeal systems
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