This International Standard 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 International Standard also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device. This International Standard does not apply to: — implanted oxygenators; — liquid oxygenators; — extracorporeal circuits (blood tubing); — separate heat exchangers; — separate ancillary devices.