1.1 This Standard specifies the basic requirements for sterilized, single-use extracorporeal blood-gas exchange devices (oxygenators) used to supply oxygen to, and remove carbon dioxide from, the blood of human patients.
1.2 This Standard applies to heat exchangers which are integral components of the blood-gas exchange devices, and external equipment unique to the use of the device.
1.3 This Standard does not apply to ancillary equipment or separate heat exchanger devices which are not part of the blood-gas exchange device.
1.4 Language Requirement