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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 058 Date of Entry 05/30/2022 
FR Recognition Number 6-482
AAMI  TIR101:2021
Fluid delivery performance testing for infusion pumps
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.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5725 Pump, Infusion Class 2 FRN
§880.5725 Pump, Infusion, Insulin Class 2 LZG
§880.5725 Pump, Infusion, Enteral Class 2 LZH
§880.5725 Pump, Infusion, Elastomeric Class 2 MEB
§880.5725 Accessories, Pump, Infusion Class 2 MRZ
§880.5725 Pump, Infusion, Insulin Bolus Class 2 OPP
§880.5725 Infusion Safety Management Software Class 2 PHC
Relevant FDA Guidance and/or Supportive Publications*
Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff, issued December 2, 2014.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Jake Lindstrom
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.