Recognized standard
13782 Second edition 2019-04
FDA recognition 8-519 · ISO · Materials
Key facts
| Recognition number | 8-519 |
|---|---|
| Designation | 13782 Second edition 2019-04 |
| Title | Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Dec 23, 2019 |
| Scope (excerpt) | This document specifies the characteristics of, and corresponding test methods for, unalloyed tantalum sheet, rod and wire used in the manufacture of surgical implants. NOTE 1 Provision is made for two grades of tantalum. |
At a glance
- None 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: