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AAMI 18241
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AAMI 18241 2016 Edition, September 2, 2016 Cardiovascular implants and extracorporeal systems-Cardiopulmonary bypass systems-Venous bubble traps
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Description / Abstract:
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.