Recognized standard
5832-1 Sixth edition 2024-04
FDA recognition 8-621 · ISO · Materials
Key facts
| Recognition number | 8-621 |
|---|---|
| Designation | 5832-1 Sixth edition 2024-04 |
| Title | Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants. NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this… |
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: