ASTM F1854 - 09

    Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

    Active Standard ASTM F1854 | Developed by Subcommittee: F04.15

    Book of Standards Volume: 13.01

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    Significance and Use

    All of these test methods are recommended for elementary quantification of the morphological properties of porous coatings bonded to solid substrates.

    These test methods may be useful for comparative evaluations of different coatings or different lots of the same coating.

    With the exception of using the alternate mounting method, all the methods should be performed on the same working surfaces. The alternate mounting method can only be used for 9.2 and 9.3.

    A statistical estimate can be made of the distributions of the mean coating thickness and the volume percent void. No estimate can be made of the distribution of intercept lengths.

    There are limits to the accurate characterization of porosity, depending on spacing between the lines in the line grid (or points in the point grid) and the individual and cumulative fields used for the measurements. Increasing the size of the fields, increasing the number of fields, or decreasing the grid spacing will increase the accuracy of the measurements obtained.

    This method is not suitable for ceramic coatings for which accurate coating cross sections cannot be produced using metallographic techniques.

    This test method does not address characterization of coatings having a thickness of less than 300 μm.

    1. Scope

    1.1 This test method covers stereological test methods for characterizing the coating thickness, void content, and mean intercept length of various porous coatings adhering to nonporous substrates.

    1.2 A method to measure void content and intercept length at distinct levels (tissue interface gradients) through the porous coating thickness is outlined in 9.4.

    1.3 The alternate sample orientation method in 8.2 is not suitable for the tissue interface gradients method in 9.4.

    1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    E3 Guide for Preparation of Metallographic Specimens

    E883 Guide for Reflected-Light Photomicrography

    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

    UNSPSC Code

    UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)

    Referencing This Standard

    DOI: 10.1520/F1854-09

    ASTM International is a member of CrossRef.

    Citation Format

    ASTM F1854-09, Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants, ASTM International, West Conshohocken, PA, 2009,

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