ISO International Standard

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.