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Standard ÖNORM EN ISO 7199 1.10.2025 preview

ÖNORM EN ISO 7199

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024)

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STANDARD published on 1.10.2025


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The information about the standard:

Designation standards: ÖNORM EN ISO 7199
Publication date standards: 1.10.2025
SKU: NS-1241862
The number of pages: 33
Approximate weight : 99 g (0.22 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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The category - similar standards:

Implants for surgery, prosthetics and orthotics

Annotation of standard text ÖNORM EN ISO 7199 :

Dieses Dokument legt Anforderungen an sterile extrakorporale Blutgasaustauscher (Oxygenatoren) zum Einmalgebrauch fest, die zur Zufuhr von Sauerstoff in und zur Entfernung von Kohlendioxid aus Humanblut während des kardiopulmonalen Bypasses (CPB) für bis zu 6 h, der extrakorporalen Lungenunterstützung (ECLA mit venen-venen (VV)-, venen-arteriell (VA)- oder Venen-arteriell-venöse (VAV)-Kanülierungsstrategien), der kardiopulmonalen Unterstützung (CPS), der extrakorporalen Lebensunterstützung (ECLS mit VA-Kanülierungsstrategie), der extrakorporalen Kohlendioxidentfernung (ECCO2R) und anderer extrakorporaler Kreislauftechniken, die einen Blut-Gas-Austausch erfordern bestimmt sind. Dieses Dokument ist auch anwendbar für Wärmeaustauscher und arterielle Filter, die in Oxygenatoren integriert sind. Dieses Dokument ist auch anwendbar für Außengeräte, die allein für den Gebrauch mit dem Oxygenator bestimmt sind. Dieses Dokument ist nicht anwendbar für: - implantierte Oxygenatoren; - Flüssigkeits-Oxygenatoren; - extrakorporale Kreisläufe (Blutschlauchsysteme); - separate Wärmeaustauscher; - separate Hilfsgeräte; und - separate arterielle Filterleitungen.

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