Standard: AAMI 11658

CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS

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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.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 11658
Publish Date: 2012-01-01
Page Count: 20
Change Type: NEW ADDITION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active
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