NF EN ISO 7197

NF EN ISO 7197

November 2024
Standard Current

Neurosurgical implants - Sterile, single-use hydrocephalus shunts

This document specifies the performance requirements for sterile, single-use non-active hydrocephalus shunts. This includes not only the valve, but also additional components such as tubes and reservoirs.This document does not provide any recommendations on which type of valve is most suitable for any specific context of use.This document specifies the mechanical and technical requirements to manufacture shunts and the technical information of the valve to be supplied by the manufacturer.This document does not apply to active implants for the treatment of hydrocephalus.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2024

Number of pages

19 p.

Reference

NF EN ISO 7197

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-303

Print number

1

International kinship

ISO 7197:2024

European kinship

EN ISO 7197:2024
Sumary
Neurosurgical implants - Sterile, single-use hydrocephalus shunts

This document specifies the performance requirements for sterile, single-use non-active hydrocephalus shunts. This includes not only the valve, but also additional components such as tubes and reservoirs.

This document does not provide any recommendations on which type of valve is most suitable for any specific context of use.

This document specifies the mechanical and technical requirements to manufacture shunts and the technical information of the valve to be supplied by the manufacturer.

This document does not apply to active implants for the treatment of hydrocephalus.

Replaced standards (1)
NF EN ISO 7197
September 2009
Standard Cancelled
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components

Le présent document a pour principal objectif la description des exigences de sécurité et de performance requises des systèmes de dérivation stériles non réutilisables pour l'hydrocéphalie et de leurs composants, et notamment les valves, les tubulures et les réservoirs. Il ne s'applique pas aux implants actifs pour le traitement de l'hydrocéphalie. Il vient en appui aux Directives européennes sur les dispositifs médicaux. Les Directives 93/42/CE sur les dispositifs médicaux et 90/385CE sur les dispositifs médicaux implantables actifs ayant été modifiées par la Directive 2007/47/CE une nouvelle version de l'annexe ZA donnant les correspondances entre les chapitres de la norme et les exigences essentielles des Directives modifiées a été élaborée. Cette nouvelle version de l'annexe ZA est intégrée dans le présent document.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales relatives aux systèmes de dérivation
  • 5 Exigences spécifiques relatives aux composants
  • 6 Marquage et étiquetage des systèmes de dérivation
  • 7 Emballage
  • 8 Informations fournies par le fabricant
  • ZA Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
  • Bibliographie
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