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ANSI/AAMI/ISO 7199:2009 (R2014)
Cardiovascular implants and artificial organs -Blood-gas exchangers (oxygenators) (Includes A1:2012)
This 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. It also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.
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Association for the Advancement of Medical Instrumentation [aami]