Recognized standard
F1377-21
FDA recognition 8-585 · ASTM · Materials
Key facts
| Recognition number | 8-585 |
|---|---|
| Designation | F1377-21 |
| Title | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538) |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | May 30, 2022 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for use in fabricating cobalt-28chromium-6molybdenum alloy medical devices. 1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques, or in… |
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: