Recognized standard
F3335-20
FDA recognition 8-532 · ASTM · Materials
Key facts
| Recognition number | 8-532 |
|---|---|
| Designation | F3335-20 |
| Title | Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | 1.1 This standard provides guidance for assessing the manufacturing material residues in medical devices fabricated using additive manufacturing (AM) techniques, specifically, from powder bed fusion AM technologies. 1.1.1 Some of the techniques discussed in this guide may be applicable to devices… |
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: