1 Scope
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.