EN 12022:1999
(Main)Blood gas exchangers
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- 19-Jan-1999
- 05-Aug-2014
- 11.040.10
- CEN/TC 205
Blood gas exchangers
This European Standard specifies requirements for sterile, single-use, extracorporeal blood gas exchangers intended for supply of oxygen to, and removal of carbon dioxid from, the blood of humans. This European Standard also applies to heat exchangers that are integral parts of blood gas exchangers and to external equipment unique to the use of the device. This European Standard does not apply to: - implanted blood gas exchangers; - liquid exchangers; - extracorporeal circuits (blod tubing); - separate heat exchangers; - separate ancillary devices.
Blutgasaustauscher
Diese Europäische Norm legt Anforderungen an sterile extrakorporale Blutgasaustauscher zum Einmalgebrauch fest, die zur Zufuhr von Sauerstoff in das und zur Entfernung von Kohlendioxid aus dem menschlichen Blut bestimmt sind. Diese Europäische Norm gilt auch für Wärmeaustauscher, die in Blutgasaustauscher integriert sind, und für Außengeräte, die allein für den Gebrauch mit dem Gerät bestimmt sind. Diese Europäische Norm gilt nicht für: - implantierte Blutgasaustauscher; - Flüssigkeits- Blutgasaustauscher; - extrakorporale Kreisläufe (Blutschlauchsysteme).
Echangeurs gaz/sang extra corporels
La présente norme européenne précise les prescriptions relatives aux échangeurs gaz/sang extracorporels (oxygénateurs) stériles, à usage unique, destinés à oxygéner le sang des patients et à en éliminer le dioxyde de carbone. La présente norme européenne s'applique également aux échangeurs thermiques qui font partie intégrante des échangeurs gaz/sang extracorporels, et aux seuls accessoires nécessaires à l'utilisation de l'appareil. La présente norme européenne ne s'applique pas aux: - échangeurs gaz/sang extracorporels implantés; -oxygénateurs liquides;...
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Izmenjevalniki krvnih plinovBlutgasaustauscherEchangeurs gaz/sang extra corporelsBlood gas exchangers11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 12022:1999SIST EN 12022:2000en01-januar-2000SI
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