Recognized standard
F3434-20
FDA recognition 8-552 · ASTM · Materials
Key facts
| Recognition number | 8-552 |
|---|---|
| Designation | F3434-20 |
| Title | Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | 1.1 This guide addresses IQ, OQ, and PQ issues directly related to the AM machine and connected equipment. Physical facility, personnel, process and material issues are only included to the extent necessary to support machine qualification. |
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: