ASTM F2791-15
(Guide)Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
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.
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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: F2791 − 15
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 F2312 Terminology Relating to Tissue Engineered Medical
Products
1.1 This guide describes some of the more common meth-
F2450 Guide for Assessing Microstructure of Polymeric
ods that are available for measuring the topographical features
Scaffolds for Use in Tissue-Engineered Medical Products
of a surface and provides an overview of the parameters that
F2664 Guide for Assessing the Attachment of Cells to
are used to quantify them. Being able to reliably derive a set of
Biomaterial Surfaces by Physical Methods
parameters that describe the texture of biomaterial surfaces is
3
2.2 Other Standards:
a key aspect in the manufacture of safe and effective implant-
ISO 3274 Geometrical Product Specifications (GPS)—
able medical devices that have the potential to trigger an
Surface Texture: Profile Method—Nominal Characteris-
adverse biological reaction in situ.
tics of Contact (Stylus) Instruments
1.2 This guide is not intended to apply to porous structures
ISO 4287 Geometrical Product Specifications (GPS)—
with average pore dimensions in excess of approximately 50
Surface Texture: Profile Method—Terms, Definitions and
nm (0.05 μm).
Surface Texture Parameters
1.3 The values stated in SI units are to be regarded as
ISO 4288 Geometrical Product Specifications (GPS)—
standard. No other units of measurement are included in this
Surface Texture: Profile Method—Rules and Procedures
standard.
for the Assessment of Surface Texture
ISO 13565–1 Geometrical Product Specifications (GPS)—
1.4 This standard does not purport to address all of the
Surface Texture: Profile Method—Surfaces Having Strati-
safety concerns, if any, associated with its use. It is the
fied Functional Properties; Filtering and General Measure-
responsibility of the user of this standard to establish appro-
ment Conditions
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3. Terminology
1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard-
3.1 Definitions of Terms Specific to This Standard:
ization established in the Decision on Principles for the
3.1.1 biomaterial, n—any substance (other than a drug),
Development of International Standards, Guides and Recom-
synthetic or natural, that can be used as a system or part of a
mendations issued by the World Trade Organization Technical
system that treats, augments, or replaces any tissue, organ, or
Barriers to Trade (TBT) Committee.
function of the body. F2664
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
2.1 ASTM Standards:
3.1.2.1 Discussion—The evaluation length may contain one
C813 Test Method for Hydrophobic Contamination on Glass or more sampling lengths. ISO 4287
by Contact Angle Measurement
3.1.3 hydrophilic, adj—having a strong affinity for water;
wettable.
3.1.3.1 Discussion—Hydrophilic surfaces exhibit zero con-
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
tact angles. C813
Surgical Materials and Devices and is the direct responsibility of Subcommittee
3.1.4 hydrophobic, adj—having little affinity for water;
F04.42 on Biomaterials and Biomolecules for TEMPs.
Current edition approved May 1, 2015. Published June 2015. Originally nonwettable.
approved in 2009. Last previous edition approved in 2014 as F2791– 14. DOI:
3.1.4.1 Discussion—Hydrophobic surfaces exhibit contact
10.1520/F2791-15.
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
3
Standards volume information, refer to the standard’s Document Summary page on Available from American 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
---------------------- Page: 1 ----------------------
F2791 − 15
angles appreciably greater than zero: generally greater than 45° occur as results of chatter, vibration, or heat treatments
...
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 − 14 F2791 − 15
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 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
3.1.2 evaluation length, ln, n—length in the direction of the x-axis used to assess the profile under evaluation.
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 Oct. 1, 2014May 1, 2015. Published December 2014June 2015. Originally approved in 2009. Last previous edition approved in 20092014 as
F2791–09. – 14. DOI: 10.1520/F2791-14.10.1520/F2791-15.
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.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
3.1.2.1 Discussion—
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2791 − 15
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 in the body as a prosthesis, or for treatment or diagnosis. F2664
3.1.6 lay, n—the direction of the predominant surface pattern. ISO 13565–1
3.1.7 primary
...
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 − 15
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 F2312 Terminology Relating to Tissue Engineered Medical
Products
1.1 This guide describes some of the more common meth-
F2450 Guide for Assessing Microstructure of Polymeric
ods that are available for measuring the topographical features
Scaffolds for Use in Tissue-Engineered Medical Products
of a surface and provides an overview of the parameters that
F2664 Guide for Assessing the Attachment of Cells to
are used to quantify them. Being able to reliably derive a set of
Biomaterial Surfaces by Physical Methods
parameters that describe the texture of biomaterial surfaces is
3
2.2 Other Standards:
a key aspect in the manufacture of safe and effective implant-
ISO 3274 Geometrical Product Specifications (GPS)—
able medical devices that have the potential to trigger an
Surface Texture: Profile Method—Nominal Characteris-
adverse biological reaction in situ.
tics of Contact (Stylus) Instruments
1.2 This guide is not intended to apply to porous structures
ISO 4287 Geometrical Product Specifications (GPS)—
with average pore dimensions in excess of approximately 50
Surface Texture: Profile Method—Terms, Definitions and
nm (0.05 µm).
Surface Texture Parameters
1.3 The values stated in SI units are to be regarded as
ISO 4288 Geometrical Product Specifications (GPS)—
standard. No other units of measurement are included in this
Surface Texture: Profile Method—Rules and Procedures
standard.
for the Assessment of Surface Texture
ISO 13565–1 Geometrical Product Specifications (GPS)—
1.4 This standard does not purport to address all of the
Surface Texture: Profile Method—Surfaces Having Strati-
safety concerns, if any, associated with its use. It is the
fied Functional Properties; Filtering and General Measure-
responsibility of the user of this standard to establish appro-
ment Conditions
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3. Terminology
1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard-
3.1 Definitions of Terms Specific to This Standard:
ization established in the Decision on Principles for the
3.1.1 biomaterial, n—any substance (other than a drug),
Development of International Standards, Guides and Recom-
synthetic or natural, that can be used as a system or part of a
mendations issued by the World Trade Organization Technical
system that treats, augments, or replaces any tissue, organ, or
Barriers to Trade (TBT) Committee.
function of the body. F2664
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
2.1 ASTM Standards: 3.1.2.1 Discussion—The evaluation length may contain one
C813 Test Method for Hydrophobic Contamination on Glass
or more sampling lengths. ISO 4287
by Contact Angle Measurement
3.1.3 hydrophilic, adj—having a strong affinity for water;
wettable.
3.1.3.1 Discussion—Hydrophilic surfaces exhibit zero con-
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and tact angles. C813
Surgical Materials and Devices and is the direct responsibility of Subcommittee
3.1.4 hydrophobic, adj—having little affinity for water;
F04.42 on Biomaterials and Biomolecules for TEMPs.
nonwettable.
Current edition approved May 1, 2015. Published June 2015. Originally
approved in 2009. Last previous edition approved in 2014 as F2791– 14. DOI:
3.1.4.1 Discussion—Hydrophobic surfaces exhibit contact
10.1520/F2791-15.
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
3
Standards volume information, refer to the standard’s Document Summary page on Available from American 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
---------------------- Page: 1 ----------------------
F2791 − 15
angles appreciably greater than zero: generally greater than 45° occur as results of chatter, vibration, or heat treatments during
for the advancing angle. C813 the manufacture of implants. Short wavelength features super-
imposed on the long wavelength features of
...
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