This European Standard specifies requirements for sterile, single-use, extracorporeal blood gas
exchangers intended for supply of oxygen to, and rernoval of carbon dioxide 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 (blood tubing);
- separate heat exchangers;
- separate ancillary devices.
Diese Norm legt Anforderungen an sterilie extrakorporale Blutgasaustauscher (Oxygenatoren) zum Einmalgebrauch fest, die zur Zufuhr von Sauerstoff in das menschliche Blut und zur Entfernung von Kohlenstoffdioxid aus dem menschlichen Blut dienen.