Le dernier examen de cette norme date de 2023.
Cette édition reste donc d’actualité.
Résumé
PrévisualiserThis 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.
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État actuel: PubliéeDate de publication: 2012-05
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Edition: 1
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- ICS :
- 11.040.40 Implants chirurgicaux, prothèses et orthèses
Acheter cette norme
fr
| Format | Langue | |
|---|---|---|
| std 1 40 | ||
| std 2 40 | Papier |
- CHF40
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