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BS ISO 13779-3:2018+A1:2021

BS ISO 13779-3:2018+A1:2021

$167.15

Implants for surgery. Hydroxyapatite – Chemical analysis and characterization of crystallinity ratio and phase purity

Published By Publication Date Number of Pages
BSI 2021 42
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
12 4 Chemical analysis
4.1 General
4.2 Analytical methods
13 4.3 Apparatus for chemical analysis
4.4 Reagents for chemical analysis
4.4.2 Analytical grade nitric or hydrochloric acid.
4.5 Procedure
14 4.6 Expression of results
5 X-ray diffraction analysis
5.1 General
5.2 Apparatus
5.2.4 Desiccator.
15 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
16 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
17 5.6.3 Detection limit (DL) and quantification limit (QL) of foreign phases
18 5.6.4 Uncertainty for determination of foreign phases content
19 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
20 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
21 5.9.2 General
5.9.3 Procedure A
22 5.9.4 Procedure B
5.9.5 Uncertainty of the crystallinity ratio
5.9.6 Expression of results
6 Test report
24 Annex A (informative) Contamination of calcium phosphate
25 Annex B (normative) Testing of the purity of the phases used in the production of the calibration curves
27 Annex C (informative) Examples of X-ray diffraction patterns collected from various mixtures used to plot the calibration curves
32 Annex D (normative) Positions of hydroxyapatite lines used to measure the crystallinity ratio
33 Annex E (normative) Methods for the preparation of reference materials
36 Annex F (informative) Uncertainty calculation of Ca:P ratio
38 Annex G (informative) Quantitative Phase Analysis (QPA) by Rietveld Refinement of XRD Data
39 Annex H (informative) Alternative method: Determination of the crystallinity ratio
40 Bibliography

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BS ISO 13779-3:2018+A1:2021
$167.15