$73
CEI UNI EN ISO 14708-7
2023
Implants for surgery – Active implantable medical devices Part 7: Particular requirements for cochlear and auditory brainstem implant systems
- Format:
- Language(s) :
- Published :
- English
- 02/01/2023
ENGLISH
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.
| CEI UNI EN ISO 14708-7 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | CEI UNI EN ISO 14708-7 |
| Scope | Implants for surgery - Active implantable medical devices Part 7: Particular requirements for cochlear and auditory brainstem implant systems |
| Publisher | CEI - Comitato Elettrotecnico Italiano |
| Languages | English |
| State | [ Active ] |
| Publication Year | 2023 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| Edition | 23# |
| File Size | 1 file , 4.2 MB |
| Number of Pages | 82 |
| Published | 02/01/2023 |
| CEI UNI EN ISO 14708-7 | ||
|---|---|---|
| History | Publisher Year | |
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