ISO 6474-1 Surgical Implants - Test for Ceramic Materials

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 6474-1 testing. 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 document does not cover biocompatibility . It is the manufacturer's responsibility to evaluate the biocompatibility of ceramic materials produced within the framework of this document.

This wear test is designed as a screening test to evaluate the tribological properties of newly designed implant materials or combinations. A ring (20 mm diameter) oscillates on a disc (25 mm diameter) in a rotational motion of 25°. Water is used as the test liquid, but bovine serum or Ringer's solution can be used optionally. The test is stopped after 1 hours at a frequency of 100 Hz.

The amount of wear is determined by the profile measurement of the wear track. GmbH uses a computerized method to obtain the 3D results of the wear mark. Due to the in-vivo simplification of kinematics, more complex testing procedures such as common simulators must be used to gain more information.

EUROLAB assists manufacturers with ISO 6474-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.