AAMI TIR 101:2021

This document defines fluid delivery performance test methods that cover the full range of use conditions of an infusion pump in order to provide clinically relevant data of how the pump will perform in use. This document is applicable to syringe pumps, container pumps, and volumetric infusion pumps for all indicated delivery modes including enteral, patient controlled analgesia (PCA), or epidural and prescribed infusate sources (e.g., volumetric infusion pump drawing from a syringe). This document does not establish criteria for the clinical acceptability of infusion pump performance, provide guidance for test method validation, or address uncertainty of measurement.