NF EN ISO 10451

NF EN ISO 10451

September 2002
Standard Cancelled

Dental implant systems - Contents of technical file

This International Standard specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof which remains in the mouth after surgery.This International Standard is not applicable to instruments and other parts specifically made for the implant system but which do not remain in the mouth. However, documentation relating to these components may be included in the technical file.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2002

Number of pages

15 p.

Reference

NF EN ISO 10451

ICS Codes

11.060.15   Dental implants

Classification index

S91-151

Print number

1 - 07/12/2002

International kinship

ISO 10451:2002

European kinship

EN ISO 10451:2002
Sumary
Dental implant systems - Contents of technical file

This International Standard specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof which remains in the mouth after surgery.

This International Standard is not applicable to instruments and other parts specifically made for the implant system but which do not remain in the mouth. However, documentation relating to these components may be included in the technical file.

Replaced standards (1)
XP ISO/TR 10451
December 1995
Standard Cancelled
Dental implants. State of the art. Survey of materials.

Le présent document spécifie, sous forme de tableaux, une classification par famille (matériaux métalliques, polymériques, etc.) des matériaux pour implants dentaires. Des fiches de caractérisation figurent également dans le présent document, à titre d'exemple.

Standard replaced by (1)
NF EN ISO 10451
August 2010
Standard Current
Dentistry - Contents of technical file for dental implant systems

ISO 10451:2010 specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the mouth after surgery.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences
    2
  • 4.1 Généralités
    2
  • 4.2 Utilisation prévue
    2
  • 4.3 Caractéristiques relatives à la conception
    2
  • 4.4 Propriétés des produits constitutifs
    3
  • 4.5 Propriétés du dispositif fini
    4
  • 4.6 Procédé de fabrication
    4
  • 4.7 Maîtrise de la qualité du procédé de fabrication de l'implant
    4
  • 4.8 Contrôle des contaminations infectieuses et microbiennes
    5
  • 4.9 Estimation des risques
    5
  • 4.10 Évaluation clinique
    5
  • 4.11 Emballage
    5
  • 4.12 Étiquetage
    5
  • 4.13 Instructions d'utilisation
    6
  • Bibliographie
    7
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