Recognized standard
BF7:2012
FDA recognition 6-295 · AAMI · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-295 |
|---|---|
| Designation | BF7:2012 |
| Title | Blood transfusion microfilters |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard describes safety and performance requirements for disposable microfilters used for the removal of microaggregates from blood or blood products during transfusion. |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: