NF EN 12006-2

NF EN 12006-2

May 1998
Standard Cancelled

Non active surgical implants. Particular requirements for cardiac and vascular implants. Part 2 : vascular prostheses including cardiac valve conduits.

Le présent document spécifie les exigences particulières relatives aux prothèses vasculaires y compris les conduits valvulés d'origine synthétique ou biologique destinés à remplacer, reconstruire, réaliser des pontages ou des dérivations entre diverses parties du système cardio-vasculaire humain.

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Main informations

Collections

National standards and national normative documents

Publication date

May 1998

Number of pages

14 p.

Reference

NF EN 12006-2

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-201-2

Print number

1 - 05/10/2005

European kinship

EN 12006-2:1998
Sumary
Non active surgical implants. Particular requirements for cardiac and vascular implants. Part 2 : vascular prostheses including cardiac valve conduits.

Le présent document spécifie les exigences particulières relatives aux prothèses vasculaires y compris les conduits valvulés d'origine synthétique ou biologique destinés à remplacer, reconstruire, réaliser des pontages ou des dérivations entre diverses parties du système cardio-vasculaire humain.
Standard replaced by (1)
NF EN 12006-2+A1
July 2009
Standard Cancelled
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2 : vascular prostheses including cardiac valve conduits

Le présent document spécifie les exigences particulières relatives aux prothèses vasculaires y compris les conduits valvulés d'origine synthétique ou biologique destinés à remplacer, reconstruire, réaliser des pontages ou des dérivations entre diverses parties du système cardio-vasculaire humain. Il vient à l'appui des exigences essentielles de la Directive UE 93/42/CEE relative aux dispositifs médicaux.

Table of contents
  • Avant-propos
    3
  • Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Définitions
    5
  • 4 Performances prévues
    5
  • 5 Conception
    5
  • 6 Matériaux
    5
  • 7 Evaluation de la conception
    6
  • 8 Fabrication
    7
  • 9 Stérilisation
    7
  • 10 Emballage
    7
  • 11 Informations fournies par le fabricant
    7
  • Annexe A (normative) Classification des prothèses
    8
  • Annexe B (informative) Bibliographie
    9
  • Annexe C (informative) Table de concordance entre l'EN 12006-2 et l'ISO/DIS 7198
    10
  • Annexe ZA (informative) Articles de la présente norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
    12
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