Recognized standard
5832-11 Second edition 2014-09-15
FDA recognition 8-406 · ISO · Materials
Key facts
| Recognition number | 8-406 |
|---|---|
| Designation | 5832-11 Second edition 2014-09-15 |
| Title | Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6-Al 7-Nb) for use in the manufacture of surgical implants. NOTE The mechanical properties of a sample obtained from a finished… |
At a glance
- 10–99 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: