ISO 6474 discusses ceramic materials for surgical implants. ISO 6474-1 is an international standard that provides for ceramic materials based on high purity alumina for surgical implants.
ISO 6474-1 is the first part of a multi-part series that outlines 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 orthopedic joint prostheses.
Note: ISO 6474-1 does not cover biocompatibility. It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of ISO 6474-1.
ISO 6474-1 on ceramic materials based on high purity alumina for surgical implants is useful for:
No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in the ISO 6474 series has shown that an acceptable level of biological response can be expected, when the material is used in appropriate applications.
ISO 6474-1 guides in standardizing alumina ceramic surgical implants that have high mechanical strength, high level of stiffness, and excellent corrosion resistance.
ISO 6474-1 guideline assists you with requirements on Material types, Test categories, Material properties, and Material properties for Ceramic materials based on high purity alumina for surgical implants. ISO 6474-1 also provides test methods on Bulk density, Chemical composition, Microstructure, Strength properties, Young's modulus, Fracture toughness, Hardness, Wear, and Cyclic fatigue for Ceramic materials based on high purity alumina for surgical implants. This assists in the proper assessment of surgical implants.
In addition, ISO 6474-1 assist in achieving acceptable quality for surgical implants.
BS ISO 6474-1:2019 supersedes ISO 6474-1:2010, which is withdrawn. BS ISO 6474-1:2019 has technically revised its clause 6 compared to the previous edition ISO 6474-1:2010.
ISO 6474-1