SS-EN-ISO-7199 › Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)
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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.
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SS-EN ISO 7199:2017
Feb. 8, 2017
EN ISO 7199:2017(IDT); ISO 7199:2016(IDT)