90.93 Standard confirmed Apr 6, 2023
ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
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.
PUBLISHED
ISO 11658:2012
90.93
Standard confirmed
Apr 6, 2023