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ANSI/AAMI/ISO 7199:2009
Cardiovascular implants andartificial organs - Blood-gasexchangers (oxygenators)
This International Standard specifies requirements for sterile, single-use, extracorporeal blood-gasexchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, theblood of humans.This International Standard also applies to heat exchangers that are integral parts of oxygenators and toexternal 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.
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Association for the Advancement of Medical Instrumentation [aami]