| ISO 14708-3 Second edition 2017-04 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators |
| Recognition Number | Neurology |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 17-15 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Neurology |
| FDA Tech | Kristen Bowsher FDA/OMPT/CDRH/ODE/DNPMD/NSDN/ 301-796-6448 kristen.bowsher@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.
| Regulation Number | Device Name | Device Class | Product Code |
| §882.5880 | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Class 2 | GZB |
| §882.5860 | Stimulator, Neuromuscular, Implanted | Class 3 | GZC |
| §882.5850 | Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation | Class 3 | GZD |
| §882.5840 | Stimulator, Intracerebral/Subcortical, Implanted | Class 3 | GYZ |
| §882.5830 | Implanted Diaphragmatic/Phrenic Nerve Stimulator | Class 3 | GZE |
| §882.5820 | Implanted Cerebellar Stimulator | Class 3 | GZA |
| §876.5270 | Stimulator, Electrical, Implantable, For Incontinence | Class 3 | EZW |
| Unclassified | Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) | Class f | OLM |
| Unclassified | Implanted Subcortical Electrical Stimulator (Motor Disorders) | Class f | MRU |
| Unclassified | Stimulator, Autonomic Nerve, Implanted (Depression) | Class 3 | MUZ |
| Unclassified | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | Class 3 | MHY |
| There is no relevant guidance developed at this time. |