NF EN 12011

NF EN 12011

April 1998
Standard Cancelled

Instrumentation to be used in association with non-active surgical implants. General requirements

Le présent document fixe les exigences générales relatives aux instruments qui doivent être utilisés en association avec les implants chirurgicaux non actifs. Ces exigences s'appliquent aux instruments fournis pour la première fois ou refournis.

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Main informations

Collections

National standards and national normative documents

Publication date

April 1998

Number of pages

23 p.

Reference

NF EN 12011

ICS Codes

11.040.30   Surgical instruments and materials
11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-002

Print number

1 - octobre 2005

European kinship

EN 12011:1998
Sumary
Instrumentation to be used in association with non-active surgical implants. General requirements

Le présent document fixe les exigences générales relatives aux instruments qui doivent être utilisés en association avec les implants chirurgicaux non actifs. Ces exigences s'appliquent aux instruments fournis pour la première fois ou refournis.
Standard replaced by (1)
NF EN ISO 16061
January 2009
Standard Cancelled
Instrumentation for use in association with non-active surgical implants -- General requirements

Table of contents
  • Avant-propos
    3
  • 0 Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Définitions
    5
  • 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 fournies par le fabricant
    7
  • Annexe A (informative) Bibliographie
    9
  • Annexe B (informative) Liste d'un certain nombre d'applications et de matériaux constitutifs d'instruments jugés satisfaisants
    11
  • Annexe C (informative) Articles de la présente norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
    21
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