ASTM F2791-14

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

SIGNIFICANCE AND USE
4.1 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.  
4.2 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: 30-Sep-2014
• 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

• Replaces: ASTM F2791-09 - Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
• Effective Date: 01-Oct-2014
• 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-Oct-2014
• Referred By: ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
• Effective Date: 01-Oct-2014
• Referred By: ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
• Effective Date: 01-Oct-2014

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 −14
StandardGuide for
Assessment of Surface Texture of Non-Porous Biomaterials
1
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.
3
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 biomaterial, n—any substance (other than a drug),
safety concerns, if any, associated with its use. It is the
synthetic or natural, that can be used as a system or part of a
responsibility of the user of this standard to establish appro-
system that treats, augments, or replaces any tissue, organ, or
priate safety and health practices and determine the applica-
function of the body. F2664
bility of regulatory limitations prior to use.
3.1.2 evaluation length, ln, n—length in the direction of the
2. Referenced Documents x-axis used to assess the profile under evaluation.
2
3.1.2.1 Discussion—The evaluation length may contain one
2.1 ASTM Standards:
or more sampling lengths. ISO 4287
C813 Test Method for Hydrophobic Contamination on Glass
by Contact Angle Measurement 3.1.3 hydrophilic, adj—having a strong affinity for water;
wettable.
F2312 Terminology Relating to Tissue Engineered Medical
Products 3.1.3.1 Discussion—Hydrophilic surfaces exhibit zero con-
F2450 Guide for Assessing Microstructure of Polymeric tact angles. C813
Scaffolds for Use in Tissue-Engineered Medical Products
3.1.4 hydrophobic, adj—having little affinity for water;
F2664 Guide for Assessing the Attachment of Cells to
nonwettable.
Biomaterial Surfaces by Physical Methods
3.1.4.1 Discussion—Hydrophobic surfaces exhibit contact
anglesappreciablygreaterthanzero:generallygreaterthan45°
for the advancing angle. C813
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
3.1.5 implant, n—a substance or object that is put in the
Surgical Materials and Devices and is the direct responsibility of Subcommittee
body as a prosthesis, or for treatment or diagnosis. F2664
F04.42 on Biomaterials and Biomolecules for TEMPs.
Current edition approved Oct. 1, 2014. Published December 2014. Originally
3.1.6 lay, n—the direction of the predominant surface
approved in 2009. Last previous edition approved in 2009 as F2791–09. DOI:
pattern. ISO 13565–1
10.1520/F2791-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2791−14
NOTE 1—The surface shown in (A) has no directionality or lay, therefore profiles can be oriented at any angle. Profiles (dashed line arrow) are drawn
perpendicular to the lay (solid line arrow) in surfaces that have directionality (B).
FIG. 1Profile Orientation and Surface Features
3.1.7 primary profile, n—the profile after application of the measure surface
...

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: F2791 − 09 F2791 − 14
Standard Guide for
Assessment of Surface Texture of Non-Porous Biomaterials
1
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.
1. 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.
2. Referenced Documents
2
2.1 ASTM Standards:
C813 Test Method for Hydrophobic Contamination on Glass by Contact Angle Measurement
F2312 Terminology Relating to Tissue Engineered Medical Products
F2450 Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
F2664 Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
3
2.2 Other Standards:
ISO 3274 Geometrical Product Specifications (GPS)—Surface Texture: Profile Method—Nominal Characteristics of Contact
(Stylus) Instruments
ISO 4287 Geometrical Product Specifications (GPS)—Surface Texture: Profile Method—Terms, Definitions and Surface
Texture Parameters
ISO 4288 Geometrical Product Specifications (GPS)—Surface Texture: Profile Method—Rules and Procedures for the
Assessment of Surface Texture
ISO 13565–1 Geometrical Product Specifications (GPS)—Surface Texture: Profile Method—Surfaces Having Stratified
Functional Properties; Filtering and General Measurement Conditions
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 biocompatible, adj—a material may be considered biocompatible if the materials perform with an appropriate host
response in a specific application. F2312
3.1.1 biomaterial, n—any substance (other than a drug), synthetic or natural, that can be used as a system or part of a system
that treats, augments, or replaces any tissue, organ, or function of the body. F2664
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42
on Biomaterials and Biomolecules for TEMPs.
Current edition approved Aug. 1, 2009Oct. 1, 2014. Published September 2009December 2014. Originally approved in 2009. Last previous edition approved in 2009 as
F2791–09. DOI: 10.1520/F2791-09.10.1520/F2791-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2791 − 14
3.1.2 evaluation length, ln, n—length in the direction of the x-axis used to assess the profile under evaluation.
3.1.2.1 Discussion—
The evaluation length may contain one or more sampling lengths. ISO 4287
3.1.3 hydrophilic, adj—having a strong affinity for water; wettable.
3.1.3.1 Discussion—
Hydrophilic surfaces exhibit zero contact angles. C813
3.1.4 hydrophobic, adj—having little affinity for water; nonwettable.
3.1.4.1 Discussion—
Hydrophobic surfaces exhibit contact angles appreciably greater than zero: generally greater than 45° for the advancing angle.
C813
3.1.5 implant, n—a substance or object that is put
...