Recognized standard
5832-12 Third edition 2019-02
FDA recognition 8-500 · ISO · Materials
Key facts
| Recognition number | 8-500 |
|---|---|
| Designation | 5832-12 Third edition 2019-02 |
| Title | Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document specifies the requirements for two wrought cobalt 28-chromium 6-molybdenum alloys used for surgical implants. The properties apply specifically to wrought bar, rod and wire. NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from… |
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: