AAMI RD17-1994 / A1-2002

This standard is intended to provide minimum requirements to ensure safe and effective performance of hemodialysis blood tubing sets. This standard includes all tubing segments which are used to transport blood (or fluids) from a patient’s vascular access device to a hemodialyzer, as well as all tubing segments that are used to transport blood (or fluids) to a patient’s vascular access device from a hemodialyzer. In addition, all components of that tubing, including drip chambers, infusion tubings or ports, clamp occlusion segments, sampling and injection tubing segments or ports, monitor lines or ports, and segments which are used to pump blood, retain or capture air and blood debris, infuse medications or fluids, sample the blood stream, monitor pressures, and make connections to other devices, are included within the scope of this standard.