ISO 11658:2012

Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems

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.

Edition	2012
Published Date	2012
Published By	International Standardization Organisation
Page Count	6