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.Cross References:ISO 11607-1ISO 14937ISO 594-2ISO 11607-2ISO 10993-11ISO 10993-1ISO 17665-1ISO 10993-7ISO 11135-1ISO 10993-4ISO 11137-1ISO 8637:2010Incorporates the following:Amendment, December 2019