Recognized standard
5832-9 Third edition 2019-02
FDA recognition 8-492 · ISO · Materials
Key facts
| Recognition number | 8-492 |
|---|---|
| Designation | 5832-9 Third edition 2019-02 |
| Title | Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required. NOTE 1 The… |
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: