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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 054 Date of Entry 07/06/2020 
FR Recognition Number 6-447
Standard
ISO  8536-4 Sixth edition 2019-09
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
Scope/Abstract
This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5440 Set, Blood Transfusion Class 2 BRZ
§880.5440 Microfilter, Blood Transfusion Class 2 CAK
§880.5440 Stopcock, I.V. Set Class 2 FMG
§880.5440 Set, Administration, Intravascular Class 2 FPA
§880.5440 Filter, Infusion Line Class 2 FPB
§880.5440 Tubing, Fluid Delivery Class 2 FPK
§880.5440 Set, I.V. Fluid Transfer Class 2 LHI
§880.5440 Check Valve, Retrograde Flow (In-Line) Class 2 MJF
§880.5440 System/Device, Pharmacy Compounding Class 2 NEP
§880.5440 Administration Set Docking Station Class 2 ODI
§880.5440 Intravenous Extension Tubing Set Class 2 OJA
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)], Issued July 2008.

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
 Kathleen Fitzgerald
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  301-796-6292
  kathleen.fitzgerald@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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