Recognized standard
F3604-23
FDA recognition 8-627 · ASTM · Materials
Key facts
| Recognition number | 8-627 |
|---|---|
| Designation | F3604-23 |
| Title | Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion. |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 23, 2024 |
| Scope (excerpt) | 1.1 This practice provides an overview of how to perform process validation for medical devices manufactured using PBF/LB/M. The topics that will be covered include machine qualifications, software used in the manufacturing process, the importance of design specification and verification on process… |
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: