ISO 6474 is an international standard that discusses Ceramic materials for surgical implants. ISO 6474-2 provides the best industry guidance on composite materials based on a high-purity alumina matrix with zirconia reinforcement for surgical implants to standardize their quality and performance.
ISO 6474-2 is the second part of a multi-part series that 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. ISO 6474-2 is intended for composite materials which are based on an alumina matrix, that is alumina as the dominating phase in the composite with a mass fraction of >60 %, similar to the material described.
Note: ISO 6474-2 does not cover biocompatibility. It is the responsibility of the manufacturer to evaluate the biocompatibility of the specific ceramic composite material which is produced within the framework of ISO 6474-2.
ISO 6474-2 on the composite materials based on a high-purity alumina matrix is useful for:
High-purity alumina matrix with zirconia reinforcement has high strength, high toughness, high hardness, and wear properties are combined and extremely low wear rates have been detected in ring-on-disc and HP stimulator tests. ISO 6474-2 guideline assists you with material types, test categories, and test categories for composite materials based on a high-purity alumina matrix with zirconia reinforcement for surgical implants.
ISO 6474-2 also guides test methods such as bulk density, chemical composition, microstructure, strength properties, radioactivity, fracture toughness, hardness, young’s modulus, cyclic fatigue, and accelerated ageing for composite materials based on a high-purity alumina matrix with zirconia reinforcement for surgical implants.
This assists to standardize the strength, toughness, hardness, and wear property of composite materials based on a high-purity alumina matrix with zirconia reinforcement for surgical implants. In addition, support you in assessing the material effectively to produce reliable results.
BS ISO 6474-2:2019 supersedes ISO 6474-2:2012, which is withdrawn. BS ISO 6474-2:2019 has made some technical changes compared to ISO 6474-2:2012. These include:
ISO 6474-2