ISO 13779-6 Implants for Surgery, Hydroxyapatite, Part 6: Powders

EUROLAB laboratory provides testing and compliance services within the scope of ISO 13779-6 standard. ISO 13779-6 specifies requirements for hydroxyapatite powders used as raw materials for the manufacture of surgical implants or for coating surgical implants.

ISO 13779-6 does not apply to hydroxyapatite coatings, ceramic hydroxyapatite, glass ceramics, α- and β-tricalcium phosphate or other forms of calcium phosphate.

No known surgical implant material has been shown to be completely free of adverse reactions in the human body. However, long-term clinical experience with the use of material referred to in this part of ISO 13779 has shown that an acceptable level of biological response can be expected if the material is used in appropriate applications.

This part of ISO 13779 describes the properties of hydroxyapatite raw material powders used to produce high quality medical devices. However, the quality of the end device is dependent on the manufacturing process and it is recognized that a separate performance standard may be required for each end-use product.

Depending on the use of hydroxyapatite powder, other characterization tests can and should be performed.

EUROLAB assists manufacturers with ISO 13779-6 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.