Recognized standard
14708-3 Second edition 2017-04
FDA recognition 17-15 · ISO · Neurology
Key facts
| Recognition number | 17-15 |
|---|---|
| Designation | 14708-3 Second edition 2017-04 |
| Title | Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators |
| Standards developer | International Organization for Standardization |
| Specialty area | Neurology |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 3, Class 2, HDE |
| Scope (excerpt) | 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… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: