FDA-recognized standard · Materials
ISO 5832-4: Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
Yes. FDA recognizes ISO 5832-4 Fourth edition 2024-04 as recognition 8-619, entered 2024-12-23. FDA also lists ISO 5832-4 Third edition 2014-09-15 (recognition 8-405, transition period ending 2026-12-20).
Recognized editions of ISO 5832-4
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-619 | ISO 5832-4 Fourth edition 2024-04 | 2024-12-23 | Complete | — |
| 8-405 | ISO 5832-4 Third edition 2014-09-15 | 2016-04-04 | Complete | 2026-12-20 |
Regulations
FDA lists these classification regulations against ISO 5832-4: 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 5832-4
9 FDA product codes cite ISO 5832-4, 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.