FDA-recognized standard · Materials
ISO 5832-5: Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel
Yes. FDA recognizes ISO 5832-5 Fourth Edition 2022-03 as recognition 8-595, entered 2022-12-19.
Recognized editions of ISO 5832-5
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-595 | ISO 5832-5 Fourth Edition 2022-03 | 2022-12-19 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 5832-5: 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 5832-5
9 FDA product codes cite ISO 5832-5, 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.