Recognized standard
9584 Second edition 2023-10
FDA recognition 8-611 · ISO · Materials
Key facts
| Recognition number | 8-611 |
|---|---|
| Designation | 9584 Second edition 2023-10 |
| Title | Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | May 29, 2024 |
| Scope (excerpt) | This International Standard establishes a method for detecting and evaluating internal imperfections of cast metallic surgical implants and related weldments. The procedures established in this document apply to film-based methods. The recommendations on the acceptance limits for internal… |
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: