ISO 6474-1 Surgical Implants - Ceramic Materials - Standard Test for High Purity Alumina-Based Ceramic Materials

This standard specifies the characteristics and corresponding test methods of biostable ceramic bone substitute material based on high purity alumina for use as components of bone spacers, bone substitutes and orthopedic joint prostheses.

This standard does not cover biocompatibility. It is the manufacturer's responsibility to evaluate the biocompatibility of ceramic materials produced within the framework of this standard.

Samples will be produced equivalent to the normal production of implants. The same feedstock, comparable forming technology, high temperature treatment and hard machining will be applied. The shaping of the samples should be done according to the requirements of the test.

The manufacturer shall declare and justify whether the production of samples can be considered equivalent to normal production.

Finished products or parts thereof can be used to evaluate material properties. However, due to geometric limitations and the risk of damage during sample preparation, it is not recommended to manufacture samples as finished product parts for the evaluation of the following material properties.

• Force;
• Fracture toughness;
• Cyclical fatigue.

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