XRD Analysis of Hydroxyapatite for Medical Applications - Test Method - ISO 13779-3 (2008)

Overview

A detailed protocol for determination of phase purity, crystallinity, quantification of minor components and determination of Ca/P ratio is outlined in ISO 13779-3 Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity and phase purity.

Applications and Benefits

ISO 13779-1 and ISO 13779-2 define limits for a variety of properties for hydroxyapatite implants and hydroxyapatite coatings respectively.  The parameters defined are Ca/P ratio, trace levels of As, Cd, Hg and Pb, phase purity, minor phases and crystallinity.

ISO 13779-3 is referred to as the test method for determination of trace metals (by ICP), Ca/P ratio by XRD and the phase purity by X-ray diffraction (XRD) analysis.

Limits are given from the minor components alpha tricalcium phosphate (α-TCP), beta tricalcium phosphate (β-TCP), calcium tetraphosphate (TTCP) and lime (CaO).

Results can be used to confirm the mineralogy of material and comply with regulatory submissions.

Form of Results

Tabulated results of hydroxyapatite (HA), α-TCP, β-TCP, TTCP and CaO. Results are also provided for crystallinity and Ca/P ratio.

Related Tests

Trace element determination in hydroxyapatite ISO 13779-3
Trace element determination in hydroxyapatite ASTM F1185
Ca/P ratio in hydroxyapatite ASTM F1185
Phase identification and quantification by XRD.

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