NF EN 12006-3+A1

NF EN 12006-3+A1

July 2009
Standard Cancelled

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3 : endovascular devices

Le présent document fixe des exigences particulières relatives aux dispositifs endovasculaires. Il vient à l'appui des exigences essentielles de la Directive UE 93/42/CEE relative aux dispositifs médicaux.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2009

Number of pages

15 p.

Reference

NF EN 12006-3+A1

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-201-3

Print number

1 - 18/06/2009

European kinship

EN 12006-3+A1:2009
Sumary
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3 : endovascular devices

Le présent document fixe des exigences particulières relatives aux dispositifs endovasculaires. Il vient à l'appui des exigences essentielles de la Directive UE 93/42/CEE relative aux dispositifs médicaux.
Replaced standards (1)
NF EN 12006-3
January 1999
Standard Cancelled
Non active surgical implants. Particular requirements for cardiac and vascular implants. Part 3 : endovascular devices.

Le présent document fixe des exigences particulières relatives aux dispositifs endo-vasculaires.

Standard replaced by (1)
NF EN 12006-3
January 1999
Standard Cancelled
Non active surgical implants. Particular requirements for cardiac and vascular implants. Part 3 : endovascular devices.

Le présent document fixe des exigences particulières relatives aux dispositifs endo-vasculaires.

Table of contents
  • Avant-propos
    3
  • Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Définitions
    4
  • 4 Performances prévues
    5
  • 5 Attributs de conception
    5
  • 6 Matériaux
    5
  • 7 Évaluation de la conception
    5
  • 8 Fabrication
    8
  • 9 Stérilisation
    8
  • 10 Emballage
    8
  • 11 Informations fournies par le fabricant
    8
  • Annexe A (informative) Bibliographie
    9
  • Annexe B (informative) Études animales sur des endoprothèses
    11
  • Annexe ZA (informative) A1 Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE 93/42/CEE
    13
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