Reference number
ISO 6474-2:2019
International Standard
ISO 6474-2:2019
Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
Edition 2
2019-03
Preview
ISO 6474-2:2019
72592
No disponible en español
Publicado (Edición 2, 2019)
Esta publicación se revisó y confirmó por última vez en 2024. Por lo tanto, esta versión es la actual.

ISO 6474-2:2019

ISO 6474-2:2019
72592
Idioma
Formato
CHF 63
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Resumen

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.

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 >60 %, similar to the material described in ISO 6474‑1, but extended by means of a certain amount of zirconia and other defined ingredients.

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).

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.

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.

Informaciones generales

  •  : Publicado
     : 2019-03
    : Norma Internacional para revisar [90.92]
  •  : 2
     : 12
  • ISO/TC 150/SC 1
    11.040.40 
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