DS/ISO 6474-2:2014 ( Tilbagetrukket )

Kirurgiske implantater - Keramiske materialer - Del 2: Kompositmaterialer baseret på en grundmasse af alumina med høj renhed forstærket med zirconia


Status:
Tilbagetrukket
Type:
Standard
Sprog:
Engelsk
Kategori:
Erstattet af:
Pris fra:
kr. 423,00

Beskrivelse

This International Standard specifies the characteristics of, and corresponding test methods for, a bio-compatible
and bio-stable ceramic bone substitute material based on zirconia reinforced high purity alumina matrix composite
for use as components of orthopaedic joint prostheses.
This part of ISO 6474 is intended for composite materials which are based on an alumina matrix similar to the
material described in Part 1 of ISO 6474.
This International Standard is applicable for a composition of the material as described in ISO 6474-1, extended
by means of a certain amount of zirconia and other defined ingredients.
NOTE – The required properties in this International Standard ISO 6474-2 differ from 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 International Standard, 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
International Standard does not cover the biocompatibility of these inorganic additives in the human body. 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 International Standard.

Antal sider: 22

Udgivet: 2014-11-06

Godkendelsesdato: 2014-10-31

Tilbagetrækningsdato: 2019-03-19

Internationale relationer : ISO 6474-2:2012 IDT

ICS: 11.040.40 - Implantater til kirurgi, protetik og ortoptik

Varenummer: M287741


Udvalg og komiteer

Komite

  • ISO/TC 150/SC 1

Dansk udvalg

DS/S-160