NF EN 12564
NF EN 12564

NF EN 12564

March 1999
Standard Cancelled

Non-active surgical implants. Joint replacement implants. Specific requirements for knee joint replacement implants.

Le présent document fournit des exigences spécifiques relatives aux prothèses de l'articulation du genou. En matière de sécurité, il fournit des exigences relatives aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations devant être fournies par le fabricant de même que les méthodes d'essai.

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Main informations

Collections

National standards and national normative documents

Publication date

March 1999

Number of pages

12 p.

Reference

NF EN 12564

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-174

Print number

1 - février 1999

European kinship

EN 12564:1998
Sumary
Non-active surgical implants. Joint replacement implants. Specific requirements for knee joint replacement implants.

Le présent document fournit des exigences spécifiques relatives aux prothèses de l'articulation du genou. En matière de sécurité, il fournit des exigences relatives aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations devant être fournies par le fabricant de même que les méthodes d'essai.
Standard replaced by (1)
NF EN ISO 21536
NF EN ISO 21536
January 2008
Standard Cancelled
Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants

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 Conception
    5
  • 6 Matériaux
    6
  • 7 Évaluation de la conception
    6
  • 8 Fabrication
    6
  • 9 Stérilisation
    7
  • 10 Emballage
    7
  • 11 Informations devant être fournies par le fabricant
    7
  • Annexe A (normative) Évaluation du domaine angulaire du mouvement relatif des composants d'une prothèse totale de l'articulation du genou contrainte
    8
  • Annexe B (informative) Bibliographie
    9
  • Annexe ZA (informative) Articles de la présente norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
    10
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