Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024); German version EN ISO 7199:2024
Abstract
This document specifies requirements for sterile single-use extracorporeal blood gas exchangers (oxygenators) used to deliver oxygen to and remove carbon dioxide from human blood during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung support (ECLA with veno-venous (VV), veno-arterial (VAV) 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 circulatory techniques requiring blood-gas exchange. This document is also applicable to heat exchangers and arterial filters integrated into oxygenators and to external devices intended for use with the oxygenator alone. This document is not applicable to implanted oxygenators, liquid oxygenators, extracorporeal circuits (blood tubing systems), separate heat exchangers, separate auxiliary devices and separate arterial filter lines. The DIN committee NA 176-04-06 AA "Extracorporeal circuits, apparatus and disposables" is responsible for this standard.
Begin
2025-06-03
Planned document number
DIN EN ISO 7199
Project number
17600152
Responsible national committee
NA 176-04-06 AA - Extracorporeal circuits, equipment and disposables
Responsible european committee
CEN/TC 205 - Non-active medical devices
Responsible international committee
ISO/TC 150/SC 2/WG 4 - Blood gas exchangers
