ISO 6474-2:2012 PDF

Scope: This part of ISO 6474 specifies the characteristics of, and corresponding test methods for, a biocompatible and biostable ceramic-bone-substitute material based on a zirconia-reinforced, high-purity alumina matrix composite for use as a component in orthopaedic joint prostheses. This part of ISO 6474 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 NOTE The required properties in this part of ISO 6474 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 part of ISO 6474, 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 part of 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 part of ISO 6474.

ISO 6474-2:2012 history

2019 ISO 6474-2:2019 Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
2012 ISO 6474-2:2012 Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement