ISO 7199:2016

ISO 7199:2016 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.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
-      implanted oxygenators,
-      liquid oxygenators,
-      extracorporeal circuits (blood tubing),
-      separate heat exchangers,
-      separate ancillary devices, and
-      separate arterial line filter.