Norm

NEN-ISO 11658:2012 en

Cardiovasculaire implantaten en kunstmatige organen- Bloed/weefsel contact oppervlakte aanpassingen voor kunstmatige ononderbroken systemen

34,42

Over deze norm

Status Definitief
Aantal pagina's 6
Commissie Chirurgische implantaten
Gepubliceerd op 01-05-2012
Taal Engels
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.

Details

ICS-code 11.040.40
Nederlandse titel Cardiovasculaire implantaten en kunstmatige organen- Bloed/weefsel contact oppervlakte aanpassingen voor kunstmatige ononderbroken systemen
Engelse titel Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems

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