STN EN ISO 14708-7
| Name: | STN EN ISO 14708-7 |
| Validity: | Valid |
| Number of pages: | 80 |
| Language: |
EN
|
| Paper: | 28,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
25,92€ b) Without ability to print, with ability to copy (printscreen) 28,80€ c) With ability to print and copy (printscreen) 37,44€ |
| Slovak title | Chirurgické implantáty. Aktívne implantovateľné zdravotnícke pomôcky. Časť 7: Osobitné požiadavky na systémy kochleárnych implantátov a kmeňových implantátov na zlepšenie sluchu (ISO 14708-7: 2019) |
| English title | Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019) |
| Release Date: | 01. 10. 2022 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 3001 |
| Level of incorporation: | idt EN ISO 14708-7:2022, idt ISO 14708-7:2019 |
| Official Journal | 09/22 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |