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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

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)]. (General Plastic Surgery/General Hospital)

Date of Standard: 2010. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
All Intravenous, Infusion sets and accessories
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
§880.5440 Adminstration 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 Guidance:
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
  10903 New Hampshire Avenue WO66 RM2510
  Silver Spring MD 20993
  email: kathleen.fitzgerald@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036