Establishes minimum labeling and performance requirements for mechanical and electromechanical infusion devices intended for use with parenteral fluids for such purposes as parenteral nutrition and administration of drugs and routine fluids. Devices included within the scope of this standard are (a) infusion devices that actively control flow (i.e., maintain a fixed preset delivery rate within certain limits despite normally varying external conditions) at rates of 0.1 ml/hour or greater; and (b) disposable functional elements, i.e., device administration sets provided or recommended specifically for use with devices within the scope of this standard. Also covered by this standard, to the extent applicable, are closed-loop control, programmable variable-rate, and bolus infusion devices.