ANSI/AAMI/ISO 11658:2012

This standard will apply to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have a coating on the blood contact surface of the device. While standards exist for the main components used in heart-lung bypass and extracorporeal life support equipment, many of these components are currently distributed with a surface coating that comes in contact with blood. This aspect of the design of these components was not addressed in the existing standard. Rather than rewrite the existing standards, a single standard will address the composition, the mechanical and biological characteristics, performance and safety of these coating for all the components. Annex 3