ISO 7199:2016 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.ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.ISO 7199:2016 does not apply to- implanted oxygenators,- liquid oxygenators,- extracorporeal circuits (blood tubing),- separate heat exchangers,- separate ancillary devices, and- separate arterial line filter.
Document identifier
ISO 7199:2016
Title
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
ISO Category
TC 150/SC 2: Cardiovascular implants and extracorporeal systems
Publication date
2016-11-15
International Relationship
DIN EN ISO 7199
History of version
ISO 7199:2016 * ISO 7199:2016 * ISO 7199:2009 * ISO 7199:1996
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