NF EN ISO 14708-7

NF EN ISO 14708-7

July 2022
Standard Current

Implants for surgery - Active implantable medical devices - Part 7 : Particular requirements for cochlear and auditory brainstem implant systems

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.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2022

Number of pages

90 p.

Reference

NF EN ISO 14708-7

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

C74-503-7

Print number

1

International kinship

ISO 14708-7:2019

European kinship

EN ISO 14708-7:2022
Sumary
Implants for surgery - Active implantable medical devices - Part 7 : Particular requirements for cochlear and auditory brainstem implant systems

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.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Symboles et abréviations
  • 5 Exigences générales pour les parties non implantables
  • 6 Examen et mesurage
  • 7 Dispositions générales relatives à l'emballage
  • 8 Dispositions générales relatives aux dispositifs médicaux implantables actifs
  • 9 Marquage sur l'emballage commercial
  • 10 Conception des emballages commerciaux
  • 11 Marquages sur les emballages stériles
  • 12 Conception des emballages non réutilisables
  • 13 Marquages des dispositifs médicaux implantables actifs
  • 14 Protection contre les effets biologiques causés involontairement par les dispositifs médicaux implantables actifs
  • 15 Protection du patient ou de l'utilisateur contre les dangers liés aux caractéristiques physiques externes des dispositifs médicaux implantables actifs
  • 16 Protection du patient contre les dangers liés à l'électricité
  • 17 Protection du patient contre les dangers liés à la chaleur
  • 18 Protection contre les rayonnements ionisants libérés ou émis par les dispositifs médicaux implantables actifs
  • 19 Protection contre les effets causés involontairement par les dispositifs
  • 20 Protection des dispositifs contre les dommages causés par les défibrillateurs externes
  • 21 Protection des dispositifs contre les variations induites par les champs électriques de haute puissance appliqués directement sur le patient
  • 22 Protection des dispositifs médicaux implantables actifs contre les altérations provoquées par des traitements médicaux divers
  • 23 Protection des dispositifs médicaux implantables actifs contre les forces mécaniques
  • 24 Protection des dispositifs médicaux implantables actifs contre les dommages causés par les décharges électrostatiques
  • 25 Protection des dispositifs médicaux implantables actifs contre les dommages causés par les modifications de la pression atmosphérique
  • 26 Protection des dispositifs médicaux implantables actifs contre les dommages causés par les changements de température
  • 27 Protection des dispositifs médicaux implantables actifs contre les rayonnements électromagnétiques non ionisants
  • 28 Documentation d'accompagnement
  • Annexe A (informative) Recommandations et justifications générales
  • Annexe B (informative) Relation entre les principes fondamentaux de l'ISO/TR 14283 et les articles et paragraphes du présent document
  • Annexe C (informative) Notes relatives à l'EN 45502-2-3 (base du présent document)
  • Annexe D (informative) Notes sur les mesurages des interférences électromagnétiques pour démontrer la conformité à l' Article
    27
  • Bibliographie
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