FDA-recognized standard · Physical Medicine
ISO 10328: Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
Yes. FDA recognizes ISO 10328 Second edition 2016-06-01 as recognition 16-231, entered 2021-06-07.
Recognized editions of ISO 10328
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 16-231 | ISO 10328 Second edition 2016-06-01 | 2021-06-07 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 10328: 21 CFR 890.3475, 21 CFR 890.3480.
Product codes that cite ISO 10328
12 FDA product codes cite ISO 10328, including ILE, ILG, ILH, IOY, IQI.
- ILE
- ILG
- ILH
- IOY
- IQI
- ITM
- ITQ
- ITS
- ITW
- KNP
- OHI
- PHL Powered Exoskeleton
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.