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CAN/CSA-ISO 7199-00
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CAN/CSA-ISO 7199-00
Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators) (Adopted ISO 7199:1996, first edition, 1996-12-15)More info
1ScopeThis International Standard specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) in tended 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.