ISO 13779-3:2018
Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity
This document specifies methods of test for the chemical analysis, assessment of crystallinity ratio and phase composition of hydroxyapatite-based materials such as powders, coating or bulk products.
NOTE These tests are intended to describe properties of the material and to communicate these between organizations. These tests are not written with the objective of replacing a company's internal operational and assessment tests although they could be used as such.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Chemical analysis
4.1 General
4.2 Analytical methods
4.3 Apparatus for chemical analysis
4.4 Reagents for chemical analysis
4.5 Procedure
4.6 Expression of results
5 X-ray diffraction analysis
5.1 General
5.2 Apparatus
5.3 Preparation of test samples
5.3.1 General
5.3.2 Coatings
5.3.3 Bulk sample
5.4 Calibration specimens
5.5 X-ray diffraction pattern collection
5.5.1 General
5.5.2 Identification of the crystallized phases
5.6 Calibration curves, limits and uncertainties
5.6.1 General
5.6.2 Plotting the calibration curves for the foreign phases
5.6.3 Detection limit (DL) and quantification limit (QL) of foreign phases
5.6.4 Uncertainty for determination of foreign phases content
5.7 Qualitative and quantitative determination of the foreign phases
5.7.1 Procedure
5.7.2 Expression of results
5.8 Calcium to phosphorous (Ca:P) ratio determination
5.8.1 General
5.8.2 Measurements on the sample
5.8.3 Uncertainty of Ca:P measurement
5.8.4 Expression of results
5.9 Determination of the crystallinity ratio
5.9.1 Rationale on different methods of determination of the crystallinity ratio
5.9.2 General
5.9.3 Procedure A
5.9.4 Procedure B
5.9.5 Uncertainty of the crystallinity ratio
5.9.6 Expression of results
6 Test report
Annex A (informative) Contamination of calcium phosphate
Annex B (normative) Testing of the purity of the phases used in the production of the calibration curves
Annex C (informative) Examples of X-ray diffraction patterns collected from various mixtures used to plot the calibration curves
Annex D (normative) Positions of hydroxyapatite lines used to measure the crystallinity ratio
Annex E (normative) Methods for the preparation of reference materials
Annex F (informative) Uncertainty calculation of Ca:P ratio
Annex G (informative) Quantitative Phase Analysis (QPA) by Rietveld Refinement of XRD Data
Annex H (informative) Alternative method: Determination of the crystallinity ratio
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Chemical analysis
4.1 General
4.2 Analytical methods
4.3 Apparatus for chemical analysis
4.4 Reagents for chemical analysis
4.5 Procedure
4.6 Expression of results
5 X-ray diffraction analysis
5.1 General
5.2 Apparatus
5.3 Preparation of test samples
5.3.1 General
5.3.2 Coatings
5.3.3 Bulk sample
5.4 Calibration specimens
5.5 X-ray diffraction pattern collection
5.5.1 General
5.5.2 Identification of the crystallized phases
5.6 Calibration curves, limits and uncertainties
5.6.1 General
5.6.2 Plotting the calibration curves for the foreign phases
5.6.3 Detection limit (DL) and quantification limit (QL) of foreign phases
5.6.4 Uncertainty for determination of foreign phases content
5.7 Qualitative and quantitative determination of the foreign phases
5.7.1 Procedure
5.7.2 Expression of results
5.8 Calcium to phosphorous (Ca:P) ratio determination
5.8.1 General
5.8.2 Measurements on the sample
5.8.3 Uncertainty of Ca:P measurement
5.8.4 Expression of results
5.9 Determination of the crystallinity ratio
5.9.1 Rationale on different methods of determination of the crystallinity ratio
5.9.2 General
5.9.3 Procedure A
5.9.4 Procedure B
5.9.5 Uncertainty of the crystallinity ratio
5.9.6 Expression of results
6 Test report
Annex A (informative) Contamination of calcium phosphate
Annex B (normative) Testing of the purity of the phases used in the production of the calibration curves
Annex C (informative) Examples of X-ray diffraction patterns collected from various mixtures used to plot the calibration curves
Annex D (normative) Positions of hydroxyapatite lines used to measure the crystallinity ratio
Annex E (normative) Methods for the preparation of reference materials
Annex F (informative) Uncertainty calculation of Ca:P ratio
Annex G (informative) Quantitative Phase Analysis (QPA) by Rietveld Refinement of XRD Data
Annex H (informative) Alternative method: Determination of the crystallinity ratio
Bibliography