• ASTM F 1609 : 2008 : R2014

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Standard Specification for Calcium Phosphate Coatings for Implantable Materials

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-07-2023

    Language(s):  English

    Published date:  26-03-2014

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.01, 2015 Describes the material requirements for calcium phosphate coatings for surgical implant applications.

    Scope - (Show below) - (Hide below)

    1.1This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.

    1.2In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response (1,2)2 and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems.

    1.3This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic,3 and applied by methods including, but not limited to, the following: (1) mechanical capture, (2) plasma spray deposition, (3) dipping/sintering, (4) electrophoretic deposition, (5) porcelainizing, and (6) sputtering.

    1.4Substrates may include smooth, porous, textured, and other implantable topographical forms.

    1.5This specification excludes organic coatings that may contain calcium and phosphate ionic species.

    1.6Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.

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

    Committee F 04
    Document Type Standard
    Product Note Reconfirmed 2014
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 2665 : 2021 Standard Specification for Total Ankle Replacement Prosthesis

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

    ASTM F 1185 : 2023 Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
    ASTM F 1185 : 2003 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
    ASTM F 1044 : 2005 : R2011 : EDT 1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
    ASTM F 1160 : 2005 : R2011 : EDT 1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
    ASTM F 2024 : 2000 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings (Withdrawn 2009)
    ASTM F 1854 : 2001 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
    ASTM F 1160 : 2005 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
    ASTM F 1088 : 2004 : REV A : EDT 1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM F 1147 : 1999 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
    ASTM F 1147 : 2005 : R2011 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ASTM F 1044 : 2005 : R2017 : EDT 1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
    ASTM F 1854 : 1998 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
    ASTM F 1088 : 2004 : REV A Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM F 1926 : 1999 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings
    ASTM F 1088 : 2023 Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
    ASTM F 1147 : 2005 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
    ASTM F 1160 : 2000 : EDT 1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
    ASTM F 1854 : 2015 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
    ASTM F 2024 : 2010 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
    ASTM F 1044 : 1999 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
    ASTM F 1854 : 2009 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
    ASTM F 1160 : 2014 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
    ASTM F 1088:2004 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM F 1088 : 2004 : REV A : R2010 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM F 1160 : 2014 : R2017 : EDT 1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
    ASTM F 2024 : 2010 : R2016 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
    ASTM F 2024 : 2010 : R2021 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
    ASTM F 1160 : 2000 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
    ASTM F 1147 : 2005 : R2017 : EDT 1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
    ASTM F 1044 : 2005 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
    ASTM F 1185 : 2003 : R2014 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
    ASTM F 1088 : 1987 : R1992 : EDT 1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM F 1185 : 2003 : R2009 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
    ASTM F 1088 : 2018 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM F 1854 : 2015 : REDLINE Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
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