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ISO 11658:2012

Current
Current

The latest, up-to-date edition.

Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, Russian

Published date

05-11-2012

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.

DevelopmentNote
Supersedes ISO/DIS 11658. (05/2012)
DocumentType
Standard
Pages
6
PublisherName
International Organization for Standardization
Status
Current

Standards Relationship
ANSI/AAMI/ISO 11658:2012 Identical
NEN ISO 11658 : 2012 Identical
BS ISO 11658:2012 Identical

15/30275224 DC : 0 BS ISO 18242 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CENTRIFUGAL BLOOD PUMPS
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ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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