EN ISO 13356 Standard Test for Surgical Implants, Yttria Stabilized Tetragonal Zirconia (Y-TZP) Based Ceramic Materials

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 13356 standard. EN ISO 13356 specifies requirements and corresponding test methods for a biocompatible and biostable ceramic bone replacement material based on yttria-stabilized tetragonal zirconia (yttria tetragonal zirconia polycrystalline, Y-TZP) for use as a material for surgical implants.

No known surgical implant material has been found to cause absolutely no adverse reactions in the human body. However, long-term clinical experience with the use of the material referred to in this International standard has shown that an acceptable level of biological response can be expected if the material is to be used in appropriate applications.

All test specimens All test specimens shall be prepared using the same manufacturing methods as normal implant components, including but not limited to: precursor powder; pressing technique; To make pressure; and ignition conditions unless justified by the manufacturer. It will be prepared using the same manufacturing methods as normal implant components: precursor powder; pressing technique; To make pressure; and ignition conditions unless justified by the manufacturer.

In cases where the test report requirements are not expressly stated in this standard, the test report for a particular property should be written according to the reference standard described in the subclause of this article.

EUROLAB assists manufacturers with EN ISO 13356 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.