Recognized standard
F621-12 (Reapproved 2017)
FDA recognition 8-337 · ASTM · Materials
Key facts
| Recognition number | 8-337 |
|---|---|
| Designation | F621-12 (Reapproved 2017) |
| Title | Standard Specification for Stainless Steel Forgings for Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jun 7, 2018 |
| Scope (excerpt) | This specification covers the requirements of forged stainless steel for surgical implants when the material forged conforms to Specifications F138 (UNS S31673), F1314 (UNS S21910), F1586 (UNS S31675), F2229 (UNS S29108), or F2581 (UNS R56320). |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: