Recognized standard
F3087-15
FDA recognition 8-426 · ASTM · Materials
Key facts
| Recognition number | 8-426 |
|---|---|
| Designation | F3087-15 |
| Title | Standard Specification for Acrylic Molding Resins for Medical Implant Applications |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jun 27, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers acrylic resins supplied in virgin form (typically pellets, powder, or granules) for medical implant applications. The co-polymers are limited to random co-polymers. This specification provides requirements and associated test methods for this thermoplastic when it is… |
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: