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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 031 Date of Recognition 08/06/2013 
FR Recognition Number 6-295
Standard
ANSI AAMI 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
FDA Technical Contact
 Mary Brooks
  FDA/OMPT/CDRH/ODE/DAGID/GHDB/
  301-796-6078
  Mary.Brooks@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
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