ANSI/AAMI CI86:2017(R2025)
Current
Current
The latest, up-to-date edition.
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
05-05-2025
€259.90
Excluding VAT
This standard specifies requirements, test procedures, methods and labeling for active implantable medical devices intended to treat hearing impairment by means of electrical stimulation of the cochlea. Such devices are referred to as cochlear implants or cochlear prostheses.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-662-7
|
| Pages |
179
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| IEC 61649:2008 | Weibull analysis |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
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