Recognized standard
CI86:2017
FDA recognition 4-239 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-239 |
|---|---|
| Designation | CI86:2017 |
| Title | Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 3 |
| Scope (excerpt) | This standard establishes minimum requirements for those active implantable medical devices known as cochlear implants or cochlear prostheses, which are intended to treat hearing impairment by means of electrical stimulation of the cochlea. Devices that treat hearing impairment other than by… |
At a glance
- None 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: