FDA-recognized standard · Materials
ISO 5832-11: Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
Yes. FDA recognizes ISO 5832-11 Third edition 2024-03 as recognition 8-620, entered 2024-12-23. FDA also lists ISO 5832-11 Second edition 2014-09-15 (recognition 8-406, transition period ending 2026-12-20).
Recognized editions of ISO 5832-11
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-620 | ISO 5832-11 Third edition 2024-03 | 2024-12-23 | Complete | — |
| 8-406 | ISO 5832-11 Second edition 2014-09-15 | 2016-04-04 | Complete | 2026-12-20 |
Regulations
FDA lists these classification regulations against ISO 5832-11: 21 CFR 872.3640, 21 CFR 872.3645, 21 CFR 872.3890, 21 CFR 872.3940, 21 CFR 872.3950, 21 CFR 872.3960, 21 CFR 872.4600, 21 CFR 872.4760, 21 CFR 872.4880.
Product codes that cite ISO 5832-11
11 FDA product codes cite ISO 5832-11, including DYX, DZE, DZL, ELE, ELS.
- DYX
- DZE Implant, Endosseous, Root-Form
- DZL Screw, Fixation, Intraosseous
- ELE
- ELS
- JEY Plate, Bone
- LZD
- MDL
- MPI
- MPL
- MQN
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.