ASTM F3260-18
(Test Method)Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
SIGNIFICANCE AND USE
5.1 Consideration of the flexural stiffness of medical textiles is important, as these devices often need to possess properties that allow them to conform readily to the anatomic structures they are designed to support or protect. This test method outlines the materials and methods for the determination of flexural properties along the different textile directions (that is, machine and cross-machine) and for the effects of textile surface orientation (that is, face and back orientations).
5.2 This test method can be used for quality control purposes.
5.3 This test method can be used for non-absorbable, absorbable, and partially absorbable medical textiles including films and membranes. Testing should be performed on both dry and appropriately conditioned specimens. If the specimen is fabricated from a hydrolytically degradable absorbable material or contains an absorbable component, testing after hydrolytic conditioning at appropriate time intervals should be undertaken using Test Method F1635. For partially absorbable textiles, testing should be performed through at least two time intervals that exceed the point where the absorbable component no longer contributes to the specimen’s measurable mechanical properties.
5.4 If flexural rigidity values are found to show effects related to planar and surface orientation, results from this test method could potentially help in determining if devices should be implanted or used only at specific textile directions and surface orientations. Considerations for determining device planar and surface orientations for use would include, but are not limited to, primary direction of bending once implanted or during use, anatomic structures that will interact with the device, and physiologic loads (normal, pathological, and worst-case) the device would experience during use.
5.5 No evidence has been found showing that bending length is dependent on the width. However, the tendency for specimens to curl or twist can affect...
SCOPE
1.1 This test method covers the measurement of flexural stiffness properties of medical textiles (for example, surgical mesh, films, and membranes). Bending length is measured and flexural rigidity is calculated.
1.2 This test method may be used for absorbable or non-absorbable medical textiles.
1.3 This test method measures the flexural stiffness at room temperature in air and, if used directly, may not provide an accurate measure of in-vivo behavior for implantable medical textiles.
1.4 This test method is not suitable for testing tubular samples.
1.5 The values stated in SI units are to be regarded as standard. Values in parentheses are for information only.
1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 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.
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Standards Content (Sample)
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: F3260 − 18
Standard Test Method for
1
Determining the Flexural Stiffness of Medical Textiles
This standard is issued under the fixed designation F3260; 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 E141 Practice for Acceptance of Evidence Based on the
Results of Probability Sampling
1.1 This test method covers the measurement of flexural
F1635 Test Method for in vitro Degradation Testing of
stiffness properties of medical textiles (for example, surgical
HydrolyticallyDegradablePolymerResinsandFabricated
mesh, films, and membranes). Bending length is measured and
Forms for Surgical Implants
flexural rigidity is calculated.
1.2 This test method may be used for absorbable or non-
3. Terminology
absorbable medical textiles.
3.1 Definitions:
1.3 This test method measures the flexural stiffness at room
3.1.1 flexural stiffness, n—resistance to bending, measured
temperature in air and, if used directly, may not provide an as bending length and flexural rigidity.
accurate measure of in-vivo behavior for implantable medical
3.1.2 medical textile, n—a fabric, film, or membrane used
textiles.
for medical purposes that may be woven, knit, braided, felted,
1.4 This test method is not suitable for testing tubular or nonwoven.
samples.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 back, n—with regard to textile orientation, (1) the
1.5 The values stated in SI units are to be regarded as
downward facing surface of the textile during manufacture; (2)
standard. Values in parentheses are for information only.
the inward or downward facing surface of the textile during
1.6 This standard does not purport to address all of the
normal use.
safety concerns, if any, associated with its use. It is the
3.2.2 bending length, n—general—the length of textile that
responsibility of the user of this standard to establish appro-
will bend under its own weight to a definite extent; specific—
priate safety, health, and environmental practices and deter-
the measured length of overhang divided by two (per 11.2)at
mine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accor- which the edge of the specimen touches the bend angle
indicator per the test method (per 10.6).
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
3.2.3 cross-machine direction, CD, n—the direction in the
Development of International Standards, Guides and Recom-
plane of the textile perpendicular to the direction of
mendations issued by the World Trade Organization Technical
manufacture, analogous to the weft direction for knit and
Barriers to Trade (TBT) Committee.
woven textiles.
3.2.4 face, n—with regard to textile orientation, (1) the
2. Referenced Documents
upwardfacingsurfaceofthetextileduringmanufacture;(2)the
2
2.1 ASTM Standards:
outward or upward facing surface of the textile during normal
D747 Test Method for Apparent Bending Modulus of Plas-
use.
tics by Means of a Cantilever Beam
3.2.5 flexural rigidity, n—the couple on either end of a
D1388 Test Method for Stiffness of Fabrics
textile strip of unit width bent into unit curvature.
3.2.6 machine direction, MD, n—the direction in the plane
of the textile parallel to the direction of manufacture, analo-
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
gous to the warp direction for knit and woven textiles.
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
3.2.7 weight, n—with regard to textiles, mass per unit area.
Current edition approved March 1, 2018. Published April 2018. Originally
approved in 2017. Last previous edition approved in 2017 as F3260–17. DOI:
4. Summary of Test Method
10.1520/F3260-18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.1 A specimen is slid at a specified rate in a direction
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
parallel to its long dimension, until its leading edge projects
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. from the edge of a horizontal surface. The length of the
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3260 − 18
overhang
...
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: F3260 − 17 F3260 − 18
Standard Test Method for
1
Determining the Flexural Stiffness of Medical Textiles
This standard is issued under the fixed designation F3260; 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 the measurement of flexural stiffness properties of medical textiles (for example, surgical mesh,
films, and membranes). Bending length is measured and flexural rigidity is calculated.
1.2 This test method may be used for absorbable or non-absorbable medical textiles.
1.3 This test method measures the flexural stiffness at room temperature in air and, if used directly, may not provide an accurate
measure of in-vivo behavior for implantable medical textiles.
1.4 This test method is not suitable for testing tubular samples.
1.5 The values stated in SI units are to be regarded as standard. Values in parentheses are for information only.
1.6 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, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.7 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
D1388 Test Method for Stiffness of Fabrics
E141 Practice for Acceptance of Evidence Based on the Results of Probability Sampling
F1635 Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for
Surgical Implants
3. Terminology
3.1 Definitions:
3.1.1 flexural stiffness, n—resistance to bending, measured as bending length and flexural rigidity.
3.1.2 medical textile, n—a fabric, film, or membrane used for medical purposes that may be woven, knit, braided, felted, or
nonwoven.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 back, n—with regard to textile orientation,(1) the downward facing surface of the textile during manufacture; (2) the
inward or downward facing surface of the textile during normal use.
3.2.2 bending length, n—general—the length of textile that will bend under its own weight to a definite extent; specific—the
measured length of overhang divided by two (per 11.2) at which the edge of the specimen touches the bend angle indicator per
the test method (per 10.6).
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 Aug. 1, 2017March 1, 2018. Published September 2017April 2018. Originally approved in 2017. Last previous edition approved in 2017 as
F3260–17. DOI: 10.1520/F3260-17.10.1520/F3260-18.
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 ----------------------
F3260 − 18
3.2.3 cross-machine direction, CD, n—the direction in the plane of the textile perpendicular to the direction of manufacture,
analogous to the weft direction for knit and woven textiles.
3.2.4 face, n—with regard to textile orientation,(1) the upward facing surface of the textile during manufacture; (2) the outward
or upward facing surface of the textile during normal use.
3.2.5 flexural rigidity, n—the couple on either end of a textile strip of unit width bent into unit curvature.
3.2.6 machine direction, MD, n—the direction in the plane of the textile parallel to the direction of manufacture, analogous to
the warp direction for knit and woven textiles.
3.2.7 weight, n—with regard to textiles, mass per unit area.
4. Summary of Test Method
4.1 A specim
...
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