ASTM F2791-09

Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions

SIGNIFICANCE AND USE
The term “surface texture” is used to describe the local deviations of a surface from an ideal shape. Surface texture usually consists of long wavelength repetitive features that occur as results of chatter, vibration, or heat treatments during the manufacture of implants. Short wavelength features superimposed on the long wavelength features of the surface, which arise from polishing or etching of the implant, are referred to as roughness.  
This guide provides an overview of techniques that are available for measuring the surface in terms of Cartesian coordinates and the parameters used to describe surface texture. It is important to appreciate that it is not possible to measure surface texture per se, but to derive values for parameters that can be used to describe it.
SCOPE
1.1 This guide describes some of the more common methods that are available for measuring the topographical features of a surface and provides an overview of the parameters that are used to quantify them. Being able to reliably derive a set of parameters that describe the texture of biomaterial surfaces is a key aspect in the manufacture of safe and effective implantable medical devices that have the potential to trigger an adverse biological reaction in situ.
1.2 This guide is not intended to apply to porous structures with average pore dimensions in excess of approximately 50 nm (0.05 μm).
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.

General Information

• Status: Historical
• Publication Date: 31-Jul-2009
• ICS: 17.040.20 - Properties of surfaces
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.42 - Biomaterials and Biomolecules for TEMPs

Relations

• Replaced By: ASTM F2791-14 - Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
• Effective Date: 01-Oct-2014
• Referred By: ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
• Effective Date: 01-Aug-2009
• Referred By: ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
• Effective Date: 01-Aug-2009
• Referred By: ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
• Effective Date: 01-Aug-2009

Standards Content (Sample)

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:F2791 −09
StandardGuide for
Assessment of Surface Texture of Non-Porous Biomaterials
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in Two Dimensions
This standard is issued under the fixed designation F2791; 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.
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1. Scope 2.2 Other Standards:
ISO 3274 Geometrical Product Specifications (GPS)—
1.1 This guide describes some of the more common meth-
Surface Texture: Profile Method—Nominal Characteris-
ods that are available for measuring the topographical features
tics of Contact (Stylus) Instruments
of a surface and provides an overview of the parameters that
ISO 4287 Geometrical Product Specifications (GPS)—
are used to quantify them. Being able to reliably derive a set of
Surface Texture: Profile Method—Terms, Definitions and
parameters that describe the texture of biomaterial surfaces is
Surface Texture Parameters
a key aspect in the manufacture of safe and effective implant-
ISO 4288 Geometrical Product Specifications (GPS)—
able medical devices that have the potential to trigger an
Surface Texture: Profile Method—Rules and Procedures
adverse biological reaction in situ.
for the Assessment of Surface Texture
1.2 This guide is not intended to apply to porous structures
ISO 13565–1 Geometrical Product Specifications (GPS)—
with average pore dimensions in excess of approximately 50
SurfaceTexture: Profile Method—Surfaces Having Strati-
nm (0.05 µm).
fiedFunctionalProperties;FilteringandGeneralMeasure-
ment Conditions
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3. Terminology
standard.
3.1 Definitions of Terms Specific to This Standard:
1.4 This standard does not purport to address all of the
3.1.1 biocompatible, adj—a material may be considered
safety concerns, if any, associated with its use. It is the
biocompatibleifthematerialsperformwithanappropriatehost
responsibility of the user of this standard to establish appro-
response in a specific application. F2312
priate safety and health practices and determine the applica-
3.1.2 biomaterial, n—any substance (other than a drug),
bility of regulatory limitations prior to use.
synthetic or natural, that can be used as a system or part of a
system that treats, augments, or replaces any tissue, organ, or
2. Referenced Documents
function of the body. F2664
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2.1 ASTM Standards:
3.1.3 evaluation length, ln, n—length in the direction of the
C813 Test Method for Hydrophobic Contamination on Glass
x-axis used to assess the profile under evaluation.
by Contact Angle Measurement
3.1.3.1 Discussion—The evaluation length may contain one
F2312 Terminology Relating to Tissue Engineered Medical
or more sampling lengths. ISO 4287
Products
F2450 Guide for Assessing Microstructure of Polymeric
3.1.4 hydrophilic, adj—having a strong affinity for water;
Scaffolds for Use in Tissue-Engineered Medical Products
wettable.
F2664 Guide for Assessing the Attachment of Cells to
3.1.4.1 Discussion—Hydrophilic surfaces exhibit zero con-
Biomaterial Surfaces by Physical Methods
tact angles. C813
3.1.5 hydrophobic, adj—having little affinity for water;
nonwettable.
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This guide is under the jurisdiction of ASTM Committee F04 on Medical and
3.1.5.1 Discussion—Hydrophobic surfaces exhibit contact
Surgical Materials and Devices and is the direct responsibility of Subcommittee
anglesappreciablygreaterthanzero:generallygreaterthan45°
F04.42 on Biomaterials and Biomolecules for TEMPs.
for the advancing angle. C813
Current edition approved Aug. 1, 2009. Published September 2009. DOI:
10.1520/F2791-09.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
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Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
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F2791−09
3.1.6 implant, n—a substance or object that is put in the 4.2 This guide provides an overview of techniques that are
body as a prosthesis, or for treatment or diagnosis. F2664 available for measuring the surface in terms of Cartesian
coordinates and the parameters used to describe surface tex-
3.1.7 lay, n—the direction of the predominant surface
ture. It is important to appreciate that it is not possible to
pattern. ISO 13565–1
measure surface texture per se, but to deri
...