FDA-recognized standard · Materials
ISO 5832-12: Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
Yes. FDA recognizes ISO 5832-12 Third edition 2019-02 as recognition 8-500, entered 2019-12-23.
Recognized editions of ISO 5832-12
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-500 | ISO 5832-12 Third edition 2019-02 | 2019-12-23 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 5832-12: 21 CFR 872.3645, 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 5832-12
9 FDA product codes cite ISO 5832-12, including DYX, DZL, ELE, JEY, LZD.
- DYX
- DZL Screw, Fixation, Intraosseous
- ELE
- 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.