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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 6-318
Standard
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)]
Scope/Abstract
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.
Transition Period
FDA recognition of ISO 8536-4 Fifth edition 2010-10-01 [Rec# 6-318] will be superseded by recognition of ISO 8536-4 Sixth edition 2019-09 [Rec# 6-447]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-318] until July 11, 2021. After this transition period, declarations of conformity to [Rec# 6-318] will not be accepted.
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)], Issued July 2008.
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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