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ISO 11658:2012

Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems ISO 11658:2012

Publication date:   May 11, 2012

General information

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

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Scope

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.

Life cycle

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PUBLISHED
ISO 11658:2012
90.93 Standard confirmed
Apr 6, 2023