ISO 7199:2024

International Standard   Current Edition
· Approved on 05 September 2024 ·

Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)

ISO 7199:2024 Files

English 22 Pages
Current Edition
153.28 USD

ISO 7199:2024 Scope

This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques requiring blood-gas exchange.

This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.

This document also applies to external equipment unique to the use of the oxygenator.

This document does not apply to

     implanted oxygenators,

     liquid oxygenators,

     extracorporeal circuits (blood tubing),

     separate heat exchangers,

     separate ancillary devices, and

     separate arterial line filters.

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