Cookies
We need your consent to use the individual data so that you can see information about your interests, among other things. Click "OK" to give your consent.
ČSN EN ISO 14708-7 (853010)
Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
Translate name
STANDARD published on 1.1.2023
The information about the standard:
Designation standards: ČSN EN ISO 14708-7
Classification mark: 853010
Catalog number: 515977
Publication date standards: 1.1.2023
SKU: NS-1097974
The number of pages: 84
Approximate weight : 283 g (0.62 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 14708-7 (853010):
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
Preview of the standard ČSN EN ISO 14708-7 (853010)
We recommend:
Technical standards updating
Do you want to make sure you use only the valid technical standards?
We can offer you a solution which will provide you a monthly overview concerning the updating of standards which you use.
Would you like to know more? Look at this page.
