Recognized standard
F1671/F1671M-22
FDA recognition 6-488 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-488 |
|---|---|
| Designation | F1671/F1671M-22 |
| Title | Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 29, 2023 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | 1.1 This test method is used to measure the resistance of materials used in protective clothing to penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral… |
At a glance
- 1–9 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: