ASTM F1854-15
(Test Method)Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants (Withdrawn 2024)
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants (Withdrawn 2024)
SIGNIFICANCE AND USE
5.1 All these test methods are recommended for elementary quantification of the morphological properties of porous coatings bonded to solid substrates.
5.2 These test methods may be useful for comparative evaluations of different coatings or different lots of the same coating.
5.3 All the methods should be performed on the same set of images of fields.
5.4 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.
5.5 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.
5.6 This method may be suitable for ceramic coatings if an accurate coating cross section can be produced. Producing an accurate ceramic coating cross section may require other techniques than standard metallographic techniques.
5.7 For coatings having a mean thickness less than 300 microns, it is not recommended to attempt to determine the volume percent void or the mean intercept length.
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 values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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.
WITHDRAWN RATIONALE
This test method covered stereological test methods for characterizing the coating thickness, void content, and mean intercept length of various porous coatings adhering to nonporous substrates.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this test method was withdrawn in May 2024 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1854 − 15
Standard Test Method for
Stereological Evaluation of Porous Coatings on Medical
1
Implants
This standard is issued under the fixed designation F1854; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.1.4 porous coating—coating on an implant deliberately
applied to contain void regions with the intent of enhancing the
1.1 This test method covers stereological test methods for
fixation of the implant.
characterizing the coating thickness, void content, and mean
3.1.5 substrate—the solid material to which the porous
intercept length of various porous coatings adhering to nonpo-
coating is attached.
rous substrates.
3.1.6 substrate interface—the region where the porous coat-
1.2 A method to measure void content and intercept length
ing is attached to the substrate.
at distinct levels (“Tissue Interface Gradients”) through the
porous coating thickness is outlined in 9.4.
3.1.7 tissue interface—the surface of the coating that shall
have first contact with biological tissue (i.e., the top of the
1.3 The values stated in SI units are to be regarded as
coating).
standard. No other units of measurement are included in this
standard. 3.1.8 working surface—the ground and polished face of the
metallographic mount where the images of the fields are
1.4 This standard does not purport to address all of the
captured.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4. Summary of Test Method
priate safety and health practices and determine the applica-
4.1 Mean Coating Thickness—Evenly spaced parallel grid
bility of regulatory limitations prior to use.
lines are oriented perpendicular to the coating-substrate inter-
face on a field. For each gridline, the distance from the
2. Referenced Documents
coating-substrate interface to the last contact with the porous
2
2.1 ASTM Standards:
coating material is measured as the coating thickness. The
E3 Guide for Preparation of Metallographic Specimens
average of all of the coating thickness measurements obtained
E883 Guide for Reflected–Light Photomicrography
from all the measured fields is the mean coating thickness for
that coating.
3. Terminology
4.2 Volume Percent Void—A regular grid of points is super-
3.1 Definitions of Terms Specific to This Standard:
imposed on a field from the working surface. The percentage of
3.1.1 field—the image of a portion of the working surface
points that are in contact with void areas in the coating is the
upon which measurements are performed.
volume percent of void present in that field.
3.1.2 intercept—the point on a measurement grid line pro-
4.3 Mean Void Intercept Length—Measurement grid lines
jected on a field where the line crosses from solid to void or
are oriented parallel to the substrate interface in a field. The
vice versa.
average length of the line segments overlaying the void space
3.1.3 measurement grid lines—an evenly spaced grid of
is the mean void intercept length for that field. This is a
parallel lines all of the same length.
representative measure of the scale, or size, of the pores in a
porous structure.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical
4.4 Tissue Interface Gradients—The Volume Percent Void
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
and the Mean Void Intercept Length are characterized in three
F04.15 on Material Test Methods.
200-µm-thick zones below the Tissue Interface in each field.
Current edition approved March 15, 2015. Published May 2015. Originally
approved in 1998. Last previous edition approved in 2009 as F1854 – 09. DOI:
5. Significance and Use
10.1520/F1854-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5.1 All these test methods are recommended for elementary
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
quantification of the morphological properties of porous coat-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. ings bonded to solid substrates.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1854 − 15
5.2 These test methods may be useful for comparative 8.1.1.2 If the angle between the tangent to the coating-
evaluations of different coatings o
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1854 − 09 F1854 − 15
Standard Test Method for
Stereological Evaluation of Porous Coatings on Medical
1
Implants
This standard is issued under the fixed designation F1854; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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”)(“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.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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
2
2.1 ASTM Standards:
E3 Guide for Preparation of Metallographic Specimens
E883 Guide for Reflected–Light Photomicrography
3. Terminology
3.1 Definitions:Definitions of Terms Specific to This Standard:
3.1.1 field—the portion of image of a partportion of the working surface upon which measurements are performed.
3.1.2 intercept—the point on a measurement grid line projected on a field where the line crosses from solid to void or vice versa.
3.1.3 measurement grid lines—aan evenly spaced grid of parallel lines all of the same length.
3.1.4 porous coating—coating on an implant deliberately applied to contain void regions with the intent of enhancing the
fixation of the implant.
3.1.5 substrate—the solid material to which the porous coating is attached.
3.1.6 substrate interface—the region where the porous coating is attached to the substrate.
3.1.7 working surface—the ground and polished face of the metallographic mount where the measurements are made.
3.1.7 tissue interface—the surface of the coating that shall have first contact with biological tissue (that is, (i.e., the top of the
coating).
3.1.8 working surface—the ground and polished face of the metallographic mount where the images of the fields are captured.
4. Summary of Test Method
4.1 Mean Coating Thickness—Evenly spaced parallel grid lines are oriented perpendicular to the coating-substrate interface.
interface on a field. For each gridline, the distance from the coating-substrate interface to the last contact with the porous coating
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved June 15, 2009March 15, 2015. Published August 2009May 2015. Originally approved in 1998. Last previous edition approved in 20012009 as
F1854 – 01.F1854 – 09. DOI: 10.1520/F1854-09.10.1520/F1854-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1854 − 15
material is measured as the coating thickness. The average of all of the coating thickness measurements obtained on a working
surface from all the measured fields is the mean coating thickness for that working surface. coating.
4.2 Volume Percent Void—A regular grid of points is superimposed on a field from the working surface. The percentage of points
that are in contact with void areas in the coating correlates with is the volume percent of void present.present in that field.
4.3 Mean Void Intercept Length—Measurement grid lines are oriented parallel to the substrate interface. interface in a field. The
average length of the line segments overlaying the void space is the mean void intercept length. length for that field. This is a
representative me
...
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F1854 − 15
Standard Test Method for
Stereological Evaluation of Porous Coatings on Medical
1
Implants
This standard is issued under the fixed designation F1854; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.1.4 porous coating—coating on an implant deliberately
applied to contain void regions with the intent of enhancing the
1.1 This test method covers stereological test methods for
fixation of the implant.
characterizing the coating thickness, void content, and mean
3.1.5 substrate—the solid material to which the porous
intercept length of various porous coatings adhering to nonpo-
coating is attached.
rous substrates.
3.1.6 substrate interface—the region where the porous coat-
1.2 A method to measure void content and intercept length
ing is attached to the substrate.
at distinct levels (“Tissue Interface Gradients”) through the
porous coating thickness is outlined in 9.4.
3.1.7 tissue interface—the surface of the coating that shall
have first contact with biological tissue (i.e., the top of the
1.3 The values stated in SI units are to be regarded as
coating).
standard. No other units of measurement are included in this
standard. 3.1.8 working surface—the ground and polished face of the
metallographic mount where the images of the fields are
1.4 This standard does not purport to address all of the
captured.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4. Summary of Test Method
priate safety and health practices and determine the applica-
4.1 Mean Coating Thickness—Evenly spaced parallel grid
bility of regulatory limitations prior to use.
lines are oriented perpendicular to the coating-substrate inter-
face on a field. For each gridline, the distance from the
2. Referenced Documents
coating-substrate interface to the last contact with the porous
2
2.1 ASTM Standards:
coating material is measured as the coating thickness. The
E3 Guide for Preparation of Metallographic Specimens
average of all of the coating thickness measurements obtained
E883 Guide for Reflected–Light Photomicrography
from all the measured fields is the mean coating thickness for
that coating.
3. Terminology
4.2 Volume Percent Void—A regular grid of points is super-
3.1 Definitions of Terms Specific to This Standard:
imposed on a field from the working surface. The percentage of
3.1.1 field—the image of a portion of the working surface
points that are in contact with void areas in the coating is the
upon which measurements are performed.
volume percent of void present in that field.
3.1.2 intercept—the point on a measurement grid line pro-
4.3 Mean Void Intercept Length—Measurement grid lines
jected on a field where the line crosses from solid to void or
are oriented parallel to the substrate interface in a field. The
vice versa.
average length of the line segments overlaying the void space
3.1.3 measurement grid lines—an evenly spaced grid of
is the mean void intercept length for that field. This is a
parallel lines all of the same length.
representative measure of the scale, or size, of the pores in a
porous structure.
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical
4.4 Tissue Interface Gradients—The Volume Percent Void
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
and the Mean Void Intercept Length are characterized in three
F04.15 on Material Test Methods.
200-µm-thick zones below the Tissue Interface in each field.
Current edition approved March 15, 2015. Published May 2015. Originally
approved in 1998. Last previous edition approved in 2009 as F1854 – 09. DOI:
5. Significance and Use
10.1520/F1854-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5.1 All these test methods are recommended for elementary
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
quantification of the morphological properties of porous coat-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. ings bonded to solid substrates.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1854 − 15
5.2 These test methods may be useful for comparative 8.1.1.2 If the angle between the tangent to the coating-
evaluations of different coatings or different lots of the same substrate interface at one edge of a field and the tangent to the
coating. substrate interface at the opposite
...
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