BS ISO 13779-3 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 3: CHEMICAL ANALYSIS AND CHARACTERIZATION OF CRYSTALLINITY RATIO AND PHASE PURITY

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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