Recognized standard
F3333-20
FDA recognition 8-558 · ASTM · Materials
Key facts
| Recognition number | 8-558 |
|---|---|
| Designation | F3333-20 |
| Title | Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This specification covers chopped carbon-fiber reinforced (CFR) polyetheretherketone (PEEK) polymer in pellets, filaments used in additive manufacturing, or fabricated forms. It provides requirements and associated test methods for these thermoplastic composites when they are to be used in the… |
At a glance
- 10–99 Product codes
- None 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: