FDA-recognized standard · Materials
ISO 5832-2: Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
Yes. FDA recognizes ISO 5832-2 Fourth edition 2018-03 as recognition 8-465, entered 2018-09-17.
Recognized editions of ISO 5832-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-465 | ISO 5832-2 Fourth edition 2018-03 | 2018-09-17 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 5832-2: 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 5832-2
11 FDA product codes cite ISO 5832-2, 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.