NF EN 12563
NF EN 12563

NF EN 12563

March 1999
Standard Cancelled

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

Le présent document fournit des exigences spécifiques relatives aux prothèses de l'articulation de la hanche. 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

16 p.

Reference

NF EN 12563

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-165

Print number

1 - septembre 2004

European kinship

EN 12563:1998
Sumary
Non-active surgical implants. Joint replacement implants. Specific requirements for hip joint replacement implants.

Le présent document fournit des exigences spécifiques relatives aux prothèses de l'articulation de la hanche. 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 21535
NF EN ISO 21535
January 2008
Standard Cancelled
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-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
    6
  • 6 Matériaux
    7
  • 7 Évaluation de la conception
    7
  • 8 Fabrication
    8
  • 9 Stérilisation
    8
  • 10 Emballage
    8
  • 11 Informations devant être fournies par le fabricant
    8
  • Annexe A (normative) Évaluation du domaine angulaire du mouvement relatif des composants
    10
  • Annexe B (informative) Bibliographie
    13
  • Annexe ZA (informative) Articles de la présente norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
    14
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