Recognized standard
F2820-12(2021)e1
FDA recognition 8-574 · ASTM · Materials
Key facts
| Recognition number | 8-574 |
|---|---|
| Designation | F2820-12(2021)e1 |
| Title | Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers virgin polyetherketoneketone (PEKK) polymer resin as supplied by a vendor (for example, in pellets, powder, and fabricated forms). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal… |
At a glance
- 10–99 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: