Recognized standard
5832-2 Fourth edition 2018-03
FDA recognition 8-465 · ISO · Materials
Key facts
| Recognition number | 8-465 |
|---|---|
| Designation | 5832-2 Fourth edition 2018-03 |
| Title | Implants for surgery - Metallic materials - Part 2: Unalloyed titanium |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants. Six grades of titanium based on tensile strength are listed in Table 2. NOTE The mechanical properties of a sample obtained from a finished product… |
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: