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.
| ANSI : | ANSI Approved |
| File Size : | 1
file
, 180 KB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 20 |
| Published : | 10/20/2012 |