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. Developed by the International Organization for Standardization (ISO), this part of the ISO 13779 standard specifies requirements for hydroxyapatite powders used as a raw material for the manufacture of surgical implants or for coating surgical implants.

This part of ISO 13779 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.

ISO 13779-6 specifies requirements for hydroxyapatite powders used as raw materials for the manufacture of surgical implants or for coating surgical implants.

Among the services provided by our organization within the framework of material testing services, there are also ISO 13779-6 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.