Reference number
ISO 11658:2012
ISO 11658:2012
© ISO 2025
International Standard
ISO 11658:2012
Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
Edition 1
2012-05
2012-05
ISO 11658:2012
50659
Publiée
(Edition 1, 2012)
Cette publication a été révisée et confirmée pour la dernière fois en 2023.
Cette édition reste donc d’actualité.
Résumé
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.
Informations générales
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État actuel: PubliéeDate de publication: 2012-05Stade: Norme internationale confirmée [90.93]
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Edition: 1
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Comité technique :ISO/TC 150/SC 2ICS :11.040.40
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