Recognized standard
F2101-19
FDA recognition 6-427 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-427 |
|---|---|
| Designation | F2101-19 |
| Title | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials. 1.2 This test method is a… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: