Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
NORM herausgegeben am 1.8.2017
Bezeichnung normen: ČSN EN ISO 7199
Zeichen: 856250
Katalog-Nummer: 502444
Ausgabedatum normen: 1.8.2017
Zahl der Seiten: 32
Gewicht ca.: 96 g (0.21 Pfund)
Land: Tschechische technische Norm
Kategorie: Technische Normen ČSN
This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator. This document also applies to external equipment unique to the use of the oxygenator. This document does not apply to - implanted oxygenators, - liquid oxygenators, - extracorporeal circuits (blood tubing), - separate heat exchangers, - separate ancillary devices, and - separate arterial line filter