Recognized standard
9584 First edition 1993-10-15
FDA recognition 8-159 · ISO · Materials
Key facts
| Recognition number | 8-159 |
|---|---|
| Designation | 9584 First edition 1993-10-15 |
| 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 | Jan 30, 2014 |
| Scope (excerpt) | This International Standard establishes a method for detecting and evaluating internal imperfections of cast metallic surgical implants. Guidance on the acceptance limits for internal imperfections in cast metallic surgical implants is given in annex A. |
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: