Logo
Login Sign Up
Current Revision

AAMI ANSI/AAMI CI86:2017

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
Best Price Guarantee
Instant

$330.00

2-5 Days

$330.00

SAVE 10%

$594.00


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


View in Library
or
Assoc. for the Advancement of Medical Instrumentation Logo

AAMI ANSI/AAMI CI86:2017

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting

PUBLISH DATE 2017
AAMI ANSI/AAMI CI86:2017
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 including electrical stimulation of the cochlea are not covered by this standard. This standard applies to the electrical stimulation component(s) of combination devices that treat hearing impairment using multiple means, including electrical stimulation. The tests specified in this standard are industry-accepted tests and are to be carried out on samples of devices to show compliance. This standard is also applicable to non-implantable parts and accessories of the devices, including fitting and diagnostic components. General and specific requirements are provided with regard to design verification, post-implantation device testing, reliability assessment and reporting, packaging and labeling, protections of the patient associated with design issues and device malfunctions, and protections of the device associated with environmental challenges arising from transport, storage, handling during implantation, unrelatedmedical treatments, and normal use.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number CI86
Publication Date June 1, 2017
Language en - English
Page Count 179
Revision Level
Supercedes
Committee
Loading...

Failed to load document history.

Publish Date Document Id Type View