本标准将适用于心肺旁路设备和体外生命支持设备的部件，这些部件携带血液，并在设备的血液接触面上有涂层。虽然心肺分流术和体外生命支持设备中使用的主要部件已有标准，但这些部件中的许多目前都带有与血液接触的表面涂层。现有标准中未涉及这些组件设计的这一方面。与重写现有标准不同，单一标准将针对所有组件的这些涂层的组成、机械和生物特性、性能和安全性。

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.