Recognized standard
TIR101:2021
FDA recognition 6-482 · AAMI · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-482 |
|---|---|
| Designation | TIR101:2021 |
| Title | Fluid delivery performance testing for infusion pumps |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 30, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: