Your needs: analyse and characterize your HAP powders (hydroxyapatite )
HAP powders and medical devices
Hydroxyapatite, or HAP, is used in the Medical Devices sector to manufacture surgical implants as a filling material. This bioactive ceramic is used in particular for its biocompatibility, resistant mechanical properties, porous morphology and bioresorbability.
What does ISO 13779-3 say?
ISO 13779-3:2018, entitled ‘Surgical implants – Hydroxyapatite – Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity’, specifies test methods for the chemical analysis, crystallinity ratio assessment and phase composition of hydroxyapatite-based materials, such as powders, coatings or solid products.
These tests are intended to describe the properties of the material and to facilitate communication between different organisations. They are not intended to replace a company’s own internal performance and evaluation tests, although they may be used for this purpose.
ISO 13779-3:2018 introduces a new method for measuring the crystallinity ratio of hydroxyapatite and proposes the Rietveld method as an alternative for quantifying foreign phase content.
Chemical analysis of medical devices
The chemical analysis used to assess the purity of hydroxyapatite powders (HAP) must meet the precise criteria set out in standard NF ISO 13779-3 (standard available at www.boutique.afnor.org).
The support of an analysis and expertise laboratory enables you to carry out your industrial projects while ensuring the conformity of your products.
FILAB also offers ASTM F1854 analyses to study the porosity of PAH coatings on implants.
Our solutions: offer you expertise and a range of analytical methods for the characterization of your HAP powders
Why choose FILAB for HAP powder analysis?
The FILAB laboratory is accredited for the analysis of PAH powders for surgical implants according to the ISO 13779-3 standard.
With state-of-the-art analytical equipment and a qualified team of doctors and engineers, the Filab laboratory analyses and characterises your PAH hydroxyapatite powders according to the standard NF ISO 13779-3, offering the following services:
Chemical analysis of the composition of hydroxyapatite PAH powders
Characterization and determination of the crystallinity rate of a hydroxyapatite powder by X-ray Diffraction (XRD)
Solubility tests on HAP hydroxyapatite powder
Determination of the presence of foreign phases (alpha-TCP, Beta-TCP, CaO and TTCP) by XRD
Measurement of the Ca/P ratio
Detection of oxyapatite by FTIR
Granulometric analysis of powders by laser granulometry
Analysis in accordance with ASTM F1854
Through our three levels of services – analysis, expertise and R&D support – FILAB helps companies of all sectors and sizes to solve their industrial problems, by providing its customers with the know-how and experience of its team.
