NF EN ISO 7199, S93-300 (09/2024)

ISO 7199:2016 specifies the requirements for sterile, single-use extracorporeal gas/blood exchangers (oxygenators) intended to oxygenate patients' blood and eliminate carbon dioxide. ISO 7199:2016 also applies to heat exchangers and arterial filters which are an integral part of oxygenators. It also applies to external equipment specific to the use of the oxygenator. ISO 7199:2016 does not apply to: - implanted oxygenators, - liquid oxygenators, - extracorporeal circuits (blood tubing), - non-integrated heat exchangers, - separate ancillary devices, and - separate arterial line filters.
(Automatic translation from French)