EN ISO 14708-7:2022

Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)

General information

60.60 Standard published   Jul 27, 2022

CEN/CENELEC

CEN/CLC/JTC 16 CEN/CENELEC Joint Technical Committee on Active Implantable Medical Devices

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

Scope

This document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this document.
The tests that are specified in this document are type tests and are to be carried out on samples of a device to show compliance.
This document is also applicable to non-implantable parts and accessories of the devices (see NOTE).
The electrical characteristics of the implantable part are determined by either the appropriate method detailed in this document or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document applies.
NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, this document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part.

Life cycle

NOW

PUBLISHED
EN ISO 14708-7:2022
60.60 Standard published
Jul 27, 2022