FDA-recognized standard · Neurology
ISO 14708-3: Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
Yes. FDA recognizes ISO 14708-3 Second edition 2017-04 as recognition 17-15, entered 2018-06-07.
Recognized editions of ISO 14708-3
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 17-15 | ISO 14708-3 Second edition 2017-04 | 2018-06-07 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 14708-3: 21 CFR 876.5270, 21 CFR 882.5820, 21 CFR 882.5830, 21 CFR 882.5840, 21 CFR 882.5850, 21 CFR 882.5860, 21 CFR 882.5880.
Product codes that cite ISO 14708-3
12 FDA product codes cite ISO 14708-3, including EZW, GYZ, GZA, GZB, GZC.
- EZW
- GYZ
- GZA
- GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
- GZC
- GZD
- GZE
- HDE
- MHY
- MRU
- MUZ
- OLM
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.