ISO 11658:2012

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

Publication date: May 11, 2012

General information

Current stage: 90.60 Effective date: Dec 3, 2022

Originator: ISO

Owner: ISO/TC 150/SC 2

Type: International Standard

ICS: 11.040.40

Languages: English Russian

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Status: Published

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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

NOW

PUBLISHED
ISO 11658:2012
90.60 Close of review
Dec 3, 2022

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