BS ISO 13779-3:2008 Implants for surgery. Hydroxyapatite. Chemical analysis and characterization of crystallinity and phase purity
BS ISO 13779 consists of the following parts, under the general title Implants for surgery — Hydroxyapatite:
Part 1: Ceramic hydroxyapatite
Part 2: Coatings of hydroxyapatite
Part 3: Chemical analysis and characterization of crystallinity and phase purity
Part 4: Determination of coating adhesion strength
No known surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body. However, long term clinical experience of the use of the material referred to in BS ISO 13779-3 has shown that an applicable level of biological response can be expected, if the material is used in appropriate applications.
The biological response to coating of hydroxyapatite ceramic has been demonstrated by a history of its clinical use and by laboratory studies.
BS ISO 13779-3 specifies methods of test for the chemical analysis and assessment of crystallinity and phase composition of hydroxyapatite-based materials such as coatings and sintered products.
Contents of BS ISO 13779-3 contain:
- Scope
- Normative references
- Terms, definitions and symbols
- Analytical methods
- Apparatus, reagents and calibration specimens
- Apparatus for chemical analysis
- Reagents for chemical analysis
- Apparatus and calibration specimens for X-ray diffraction analysis
- Infrared apparatus
- X-Ray diffraction pattern collection
- Identification of the crystallized phases
- Preparation of the test sample
- Coatings
- Bulk sample
- X-ray analysis
- Plotting the calibration curves
- Chemical analysis
- Expression of results
- Ca:P ratio
- Procedure
- Measurements on the sample
- Choice of the diffraction peaks
- Expression of results
- Qualitative and quantitative determination of the foreign phases
- Procedure
- Expression of results
- Determination of the crystallinity ratio
- Preparation of the sample
- Procedure
- Expression of results
- Degradation of ceramics
- Test report
- Contamination of calcium phosphate
- Testing of the purity of the phases used in the production of the calibration curves
- Examples of X-ray diffraction patterns collected from various mixtures used to plot the calibration curves
- Positions of lines used to measure the crystallinity ratio
- Examples of methods for the preparation of reference materials
- Bibliography