NF ISO 6474-2

NF ISO 6474-2

July 2012
Standard Cancelled

Implants for surgery - Ceramic materials - Part 2 : composite materials based on a high-purity alumina matrix with zirconia reinforcement

Le présent document spécifie les caractéristiques et les méthodes d'essai correspondantes des matériaux céramiques biocompatibles et biostables servant de substitut à l'os, à base d'un matériau composite à matrice alumine de haute pureté renforcée par des grains de zircone, ces matériaux étant utilisés comme composants de prothèses articulaires en chirurgie orthopédique. Il traite des matériaux composites comprenant une matrice alumine (c'est-à-dire une phase dominante d'alumine dans le matériau composite avec une fraction massique > 60 %) similaire au matériau décrit dans la norme homologuée NF ISO 6474-1, additionné d'une certaine quantité de zircone et d'autres ingrédients définis.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2012

Number of pages

18 p.

Reference

NF ISO 6474-2

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-064-2

Print number

1 - 20/06/2012

International kinship

ISO 6474-2:2012
Sumary
Implants for surgery - Ceramic materials - Part 2 : composite materials based on a high-purity alumina matrix with zirconia reinforcement

Le présent document spécifie les caractéristiques et les méthodes d'essai correspondantes des matériaux céramiques biocompatibles et biostables servant de substitut à l'os, à base d'un matériau composite à matrice alumine de haute pureté renforcée par des grains de zircone, ces matériaux étant utilisés comme composants de prothèses articulaires en chirurgie orthopédique. Il traite des matériaux composites comprenant une matrice alumine (c'est-à-dire une phase dominante d'alumine dans le matériau composite avec une fraction massique > 60 %) similaire au matériau décrit dans la norme homologuée NF ISO 6474-1, additionné d'une certaine quantité de zircone et d'autres ingrédients définis.
Standard replaced by (1)
NF ISO 6474-2
October 2019
Standard Current
Implants for surgery - Ceramic materials - Part 2 : composite materials based on a high-purity alumina matrix with zirconia reinforcement

<p>This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic-bone-substitute material based on a zirconia-reinforced, high-purity alumina matrix composite for use as bone spacers, bone replacements and components in orthopaedic joint prostheses.</p> <p>This document is intended for composite materials which are based on an alumina matrix, i.e. alumina as the dominating phase in the composite with a mass fraction of &gt;60 %, similar to the material described in ISO 6474‑1, but extended by means of a certain amount of zirconia and other defined ingredients.</p> <p>NOTE The required properties in this document differ from those in ISO 6474‑1 with respect to strength and fracture toughness. Furthermore, there are requirements specifically applicable for zirconia-containing materials (see ISO 13356).</p> <p>In the material composition as defined in this document, additional additives are listed. Typical additives for alumina or zirconia ceramics are Mg, Y, Ce and others. Such additives can be useful in order to improve the mechanical properties and/or the chemical stability of the alumina-zirconia composite material.</p> <p>This document does not cover biocompatibility (see ISO 10993‑1). It is the responsibility of the manufacturer to evaluate the biocompatibility of the specific ceramic composite material which is produced within the framework of this document.</p>

Table of contents
View the extract
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Classification
    3
  • 3.1 Types du matériau
    3
  • 3.2 Catégories d'essai
    3
  • 3.3 Propriétés du matériau
    4
  • 4 Préparation des éprouvettes
    5
  • 5 Méthodes d'essai
    6
  • 5.1 Masse volumique apparente
    6
  • 5.2 Composition chimique
    7
  • 5.3 Microstructure
    7
  • 5.4 Propriétés de résistance
    8
  • 5.5 Radioactivité
    9
  • 5.6 Ténacité
    9
  • 5.7 Dureté
    10
  • 5.8 Module de Young
    10
  • 5.9 Tenue à la fatigue
    10
  • 5.10 Vieillissement accéléré
    10
  • Bibliographie
    12
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