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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 031 Date of Entry 08/06/2013 
FR Recognition Number 6-295
Standard
AAMI ANSI  BF7:2012
Blood transfusion microfilters
Scope/Abstract
This standard describes safety and performance requirements for disposable microfilters used for the removal of
microaggregates from blood or blood products during transfusion.
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 Microfilter, Blood Transfusion Class 2 CAK
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

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
 Kyran Gibson
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  --
  Kyran.Gibson@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.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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