FDA-recognized standard · Materials
ISO 5832-1: Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
Yes. FDA recognizes ISO 5832-1 Sixth edition 2024-04 as recognition 8-621, entered 2024-12-23. FDA also lists ISO 5832-1 Fifth edition 2016-07-15 (recognition 8-435, transition period ending 2026-12-20).
Recognized editions of ISO 5832-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-621 | ISO 5832-1 Sixth edition 2024-04 | 2024-12-23 | Complete | — |
| 8-435 | ISO 5832-1 Fifth edition 2016-07-15 | 2016-12-23 | Complete | 2026-12-20 |
Regulations
FDA lists these classification regulations against ISO 5832-1: 21 CFR 872.4600, 21 CFR 872.4760, 21 CFR 872.4880.
Product codes that cite ISO 5832-1
5 FDA product codes cite ISO 5832-1, including DYX, DZL, JEY, MDL, 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.