ISO 7199:2009 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 7199:2009 also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.
Status : WithdrawnPublication date : 2009-04
Edition : 2Number of pages : 11
Technical Committee:Cardiovascular implants and extracorporeal systems