ANSI AAMI BF7:2012

Standard Organization:

ANSI AAMI BF7:2012
Blood transfusion microfilters

Recognition Date2013-08-06
Recognition List031
Recognition Number6-295
Extent Complete standard
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STG General Plastic Surgery/General Hospital
FDA Tech  Mary Brooks   FDA/OMPT/CDRH/ODE/DAGID/GHDB/   301-796-6078   Mary.Brooks@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This standard describes safety and performance requirements for disposable microfilters used for the removal of

microaggregates from blood or blood products during transfusion.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§880.5440 Microfilter, Blood Transfusion Class 2 CAK

FDA Guidance:

Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on: July 11, 2008


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