Recognized standard
F754-24
FDA recognition 8-628 · ASTM · Materials
Key facts
| Recognition number | 8-628 |
|---|---|
| Designation | F754-24 |
| Title | Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification describes the physical, chemical, and mechanical performance requirements for polytetrafluoroethylene (PTFE) pre-fabricated by compression molding or extrusion into sheet, tube, and rod shapes which may be used for implant products. 1.2 PTFE is a high molecular weight straight… |
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: