Recognized standard
5832-1 Fifth edition 2016-07-15
FDA recognition 8-435 · ISO · Materials
Key facts
| Recognition number | 8-435 |
|---|---|
| Designation | 5832-1 Fifth edition 2016-07-15 |
| 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, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 5832 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… |
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: