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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 6-318
ISO 8536-4 Fifth edition 2010-10-01
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013)]
ISO 8536‑4:2010 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 ISO 8536‑4:2010 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.

In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.

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 Administration Set Docking Station Class 2 ODI
§880.5440 Check Valve, Retrograde Flow (In-Line) Class 2 MJF
§880.5440 Filter, Infusion Line Class 2 FPB
§880.5440 Intravenous Extension Tubing Set Class 2 OJA
§880.5440 Microfilter, Blood Transfusion Class 2 CAK
§880.5440 Set, Administration, Intravascular Class 2 FPA
§880.5440 Set, Blood Transfusion Class 2 BRZ
§880.5440 Set, I.V. Fluid Transfer Class 2 LHI
§880.5440 Stopcock, I.V. Set Class 2 FMG
§880.5440 System/Device, Pharmacy Compounding Class 2 NEP
§880.5440 Tubing, Fluid Delivery Class 2 FPK
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)]. Document issued on July 11, 2008
FDA Technical Contact
 Kathleen Fitzgerald
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital