Alcance
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.