• 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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee CH/150/1
    Document Type Draft
    Publisher British Standards Institution
    Status NA

    Standards Referencing This Book - (Show below) - (Hide below)

    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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