Recognized standard
F755-19
FDA recognition 8-543 · ASTM · Materials
Key facts
| Recognition number | 8-543 |
|---|---|
| Designation | F755-19 |
| Title | Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | 1.1 This specification covers the properties and test methods for porous high-density-polyethylene (HDPE) and porous ultra-high-molecular-weight-polyethylene (UHMWPE) intended for use in surgical implants. The porous polyethylene may be used as a free-standing product or as a coating on a substrate… |
At a glance
- None 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: