Standard

DS/ISO 6474-1:2019

Kirurgiske implantater – Keramiske materialer – Del 1: Keramiske materialer baseret på alumina med høj renhed

Status
Gældende Checkmark
Type
Standard
Varenummer
M308777
Udgivelsesdato
2019-03-19
Komite

ISO/TC 150/SC 1

Internationale relationer
Tooltip
ISO 6474-1:2019 IDT
Dansk udvalg
Antal sider
18

Scope

This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses. This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of this document.