Implants for surgery. Ceramic materials - Composite materials based on a high-purity alumina matrix with zirconia reinforcement
Implants for surgery. Ceramic materials - Composite materials based on a high-purity alumina matrix with zirconia reinforcement
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Implants for surgery. Ceramic materials - Composite materials based on a high-purity alumina matrix with zirconia reinforcement

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What is ISO 6474-2- Composite materials based on a high-purity alumina matrix about?  

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

Who is ISO 6474-2- Composite materials based on a high-purity alumina matrix for? 

ISO 6474-2 on the composite materials based on a high-purity alumina matrix is useful for: 

  •  Manufacturer of bio-stable ceramic-bone-substitute material 
  • Testing laboratory for bio-stable ceramic-bone-substitute material 

Why should you use ISO 6474-2- Composite materials based on a high-purity alumina matrix? 

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. 

What’s changed since the last update? 

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: 

  • The table for Limits for material property category 1 has been revised
  • The table for Limits for material property category 2 has been revised