ASTM F1854-09
(Test Method)Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
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.
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.
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Designation: F1854 − 09
StandardTest 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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.1.3 measurement grid lines—a evenly spaced grid of
parallel lines all of the same length.
1.1 This test method covers stereological test methods for
3.1.4 porous coating—coating on an implant deliberately
characterizing the coating thickness, void content, and mean
appliedtocontainvoidregionswiththeintentofenhancingthe
intercept length of various porous coatings adhering to nonpo-
fixation of the implant.
rous substrates.
3.1.5 substrate—the solid material to which the porous
1.2 A method to measure void content and intercept length
coating is attached.
at distinct levels (“tissue interface gradients”) through the
porous coating thickness is outlined in 9.4.
3.1.6 substrate interface—theregionwheretheporouscoat-
ing is attached to the substrate.
1.3 The alternate sample orientation method in 8.2 is not
suitable for the tissue interface gradients method in 9.4. 3.1.7 working surface—the ground and polished face of the
metallographic mount where the measurements are made.
1.4 The values stated in SI units are to be regarded as
3.1.8 tissue interface—the surface of the coating that shall
standard. No other units of measurement are included in this
have first contact with biological tissue (that is, the top of the
standard.
coating).
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
4. Summary of Test Method
responsibility of the user of this standard to establish appro-
4.1 Mean Coating Thickness—Evenly spaced parallel grid
priate safety and health practices and determine the applica-
lines are oriented perpendicular to the coating-substrate inter-
bility of regulatory limitations prior to use.
face. For each gridline, the distance from the coating-substrate
2. Referenced Documents
interface to the last contact with the porous coating material is
2
measured as the coating thickness. The average of all of the
2.1 ASTM Standards:
coatingthicknessmeasurementsobtainedonaworkingsurface
E3Guide for Preparation of Metallographic Specimens
is the mean coating thickness for that working surface.
E883Guide for Reflected–Light Photomicrography
4.2 Volume Percent Void—Aregular grid of points is super-
3. Terminology
imposedonafieldfromtheworkingsurface.Thepercentageof
3.1 Definitions: points that are in contact with void areas in the coating
3.1.1 field—the portion of image of a part of the working correlates with the volume percent of void present.
surface upon which measurements are performed.
4.3 Mean Void Intercept Length—Measurement grid lines
3.1.2 intercept—the point on a measurement grid line pro-
are oriented parallel to the substrate interface. The average
jected on a field where the line crosses from solid to void or
length of the line segments overlaying the void space is the
vice versa. mean void intercept length.This is a representative measure of
the scale, or size, of the pores in a porous structure.
4.4 Tissue Interface Gradients—The volume percent void
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee and the mean void intercept length are characterized in three
F04.15 on Material Test Methods.
200-µm-thick zones below the tissue interface.
Current edition approved June 15, 2009. Published August 2009. Originally
approved in 1998. Last previous edition approved in 2001 as F1854–01. DOI:
5. Significance and Use
10.1520/F1854-09.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5.1 All of these test methods are recommended for elemen-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
tary quantification of the morphological properties of porous
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. coatings 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 − 09
5.2 These test methods may be useful for comparative 8.1.1.1 For accurate coating thickness measurements, the
evaluations of different coatings or different lots of the same orientation of sample working surfaces should be approxi-
coating. mately perpendicular to the plane of the substrate.
8.1.1.2 If the angle between the
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1854–01 Designation:F1854–09
Standard Test Method for
Stereological Evaluation of Porous Coatings on Medical
1
Implants
This standard is issued under the fixed designation F 1854; 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 Thistestmethodcoversstereologicaltestmethodsforcharacterizingthecoatingthickness,voidcontent,andmeanintercept
length of various porous coatings adhering to nonporous substrates.
1.2Porous coatings with significant gradients in the porosity from the substrate to the surface will require use of the alternate
sample orientation method outlined in
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.
1.3The values stated in SI units are to be regarded as the standard.
1.4
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
2
2.1 ASTM Standards:
E3 PracticeGuide for Preparation of Metallographic Specimens
E 883 Guide for ReflectedLight Photomicrography
3. Terminology
3.1 Definitions:
3.1.1 field—the portion of image of a portionpart of the working surface upon which measurements are performed.
3.1.2 intercept—thepointonameasurementgridlineprojectedonafieldwherethelinecrossesfromsolidtovoidorviceversa.
3.1.3 measurement grid lines—a 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.
3.1.8 tissue interface—the surface of the coating that shall have first contact with biological tissue (that is, the top of the
coating).
4. Summary of Test Method
4.1 Mean Coating Thickness—Measurement grid lines are oriented perpendicular to the substrate interface. On each of the lines
in the group, the distance from the substrate interface to the last contact with the porous coating material is measured.The average
of the line lengths over the group of lines is the local mean coating thickness. —Evenly spaced parallel grid lines are oriented
perpendicular to the coating-substrate interface. For each gridline, the distance from the coating-substrate interface to the last
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 October 10, 2001. Published February 2002.
Current edition approved June 15, 2009. Published August 2009. Originally approved in 1998. Last previous edition approved in 2001 as F 1854 – 01.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 03.01.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 ----------------------
F1854–09
contact with the porous coating material is measured as the coating thickness. The average of all of the coating thickness
measurements obtained on a working surface is the mean coating thickness for that working surface.
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 the volume percent of void present.
4.3 Mean Void Intercept Length—Me
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1854–01 Designation:F1854–09
Standard Test Method for
Stereological Evaluation of Porous Coatings on Medical
1
Implants
This standard is issued under the fixed designation F 1854; 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 Thistestmethodcoversstereologicaltestmethodsforcharacterizingthecoatingthickness,voidcontent,andmeanintercept
length of various porous coatings adhering to nonporous substrates.
1.2Porous coatings with significant gradients in the porosity from the substrate to the surface will require use of the alternate
sample orientation method outlined in
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.
1.3The values stated in SI units are to be regarded as the standard.
1.4
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
2
2.1 ASTM Standards:
E3 PracticeGuide for Preparation of Metallographic Specimens
E 883 Guide for ReflectedLight Photomicrography
3. Terminology
3.1 Definitions:
3.1.1 field—the portion of image of a portionpart of the working surface upon which measurements are performed.
3.1.2 intercept—thepointonameasurementgridlineprojectedonafieldwherethelinecrossesfromsolidtovoidorviceversa.
3.1.3 measurement grid lines—a 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.
3.1.8 tissue interface—the surface of the coating that shall have first contact with biological tissue (that is, the top of the
coating).
4. Summary of Test Method
4.1 Mean Coating Thickness—Measurement grid lines are oriented perpendicular to the substrate interface. On each of the lines
in the group, the distance from the substrate interface to the last contact with the porous coating material is measured.The average
of the line lengths over the group of lines is the local mean coating thickness. —Evenly spaced parallel grid lines are oriented
perpendicular to the coating-substrate interface. For each gridline, the distance from the coating-substrate interface to the last
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 October 10, 2001. Published February 2002.
Current edition approved June 15, 2009. Published August 2009. Originally approved in 1998. Last previous edition approved in 2001 as F 1854 – 01.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 03.01.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 ----------------------
F1854–09
contact with the porous coating material is measured as the coating thickness. The average of all of the coating thickness
measurements obtained on a working surface is the mean coating thickness for that working surface.
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 the volume percent of void present.
4.3 Mean Void Intercept Length—Me
...
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