17/30302770 DC : 0
NA
Status of Standard is Unknown
BS ISO 13779-3 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 3: CHEMICAL ANALYSIS AND CHARACTERIZATION OF CRYSTALLINITY RATIO AND PHASE PURITY
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions
4 Chemical analysis
5 X-ray diffraction analysis
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 (normative) - Uncertainty calculation
of Ca/P ratio
Annex G (informative) - Quantitative Phase Analysis
(QPA) by Rietveld Refinement of XRD Data
Annex H (normative) - Alternative method - Determination
of the crystallinity ratio
Bibliography
BS ISO 13779-3.
| Committee |
CH/150/1
|
| DocumentType |
Draft
|
| Pages |
39
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 3310-1:2016 | Test sieves — Technical requirements and testing — Part 1: Test sieves of metal wire cloth |
| ISO 13779-4:2002 | Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength |
| ISO 13779-1:2008 | Implants for surgery — Hydroxyapatite — Part 1: Ceramic hydroxyapatite |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| NFS 94 067 : 1993 XP | MATERIALS FOR SURGICAL IMPLANTS - QUALITATIVE AND QUANTITATIVE - DETERMINATION OF THE FOREIGN PHASES PRESENT IN CALCIUM PHOSPHATE BASED POWDERS, DEPOSITS AND CERAMICS |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 13779-2:2008 | Implants for surgery — Hydroxyapatite — Part 2: Coatings of hydroxyapatite |
| ISO 80000-1:2009 | Quantities and units — Part 1: General |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| NFS 94 065 : 1998 | MATERIALS FOR SURGICAL IMPLANTS - DETERMINATION OF ARSENIC, MERCURY, CADMIUM AND LEAD ON COATINGS BASED ON PHOSPHATE OF CALCIUM |
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