Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps

Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps

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1   Scope

This document specifies requirements for sterile, single-use, venous bubble traps intended to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support, which may include cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), or venovenous bypass for liver transplantation.