ASTM F3260-17
(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)
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Designation: F3260 − 17
Standard Test Method for
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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 HydrolyticallyDegradablePolymerResinsandFabricated
Forms for Surgical Implants
1.1 This test method covers the measurement of flexural
stiffness properties of medical textiles (for example, surgical
3. Terminology
mesh, films, and membranes). Bending length is measured and
3.1 Definitions:
flexural rigidity is calculated.
3.1.1 flexural stiffness, n—resistance to bending, measured
1.2 This test method may be used for absorbable or non-
as bending length and flexural rigidity.
absorbable medical textiles.
3.1.2 medical textile, n—a fabric, film, or membrane used
1.3 This test method measures the flexural stiffness at room
for medical purposes that may be woven, knit, braided, felted,
temperature in air and, if used directly, may not provide an
or nonwoven.
accurate measure of in-vivo behavior for implantable medical
3.2 Definitions of Terms Specific to This Standard:
textiles.
3.2.1 back, n—with regard to textile orientation, (1) the
1.4 This test method is not suitable for testing tubular
downward facing surface of the textile during manufacture; (2)
samples.
the inward or downward facing surface of the textile during
normal use.
1.5 The values stated in SI units are to be regarded as
standard. Values in parentheses are for information only.
3.2.2 bending length, n—general—the length of textile that
will bend under its own weight to a definite extent; specific—
1.6 This standard does not purport to address all of the
the measured length of overhang divided by two (per 11.2)at
safety concerns, if any, associated with its use. It is the
which the edge of the specimen touches the bend angle
responsibility of the user of this standard to establish appro-
indicator per the test method (per 10.6).
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3.2.3 cross-machine direction, CD, n—the direction in the
1.7 This international standard was developed in accor-
plane of the textile perpendicular to the direction of
dance with internationally recognized principles on standard-
manufacture, analogous to the weft direction for knit and
ization established in the Decision on Principles for the
woven textiles.
Development of International Standards, Guides and Recom-
3.2.4 face, n—with regard to textile orientation, (1) the
mendations issued by the World Trade Organization Technical
upwardfacingsurfaceofthetextileduringmanufacture;(2)the
Barriers to Trade (TBT) Committee.
outward or upward facing surface of the textile during normal
use.
2. Referenced Documents
3.2.5 flexural rigidity, n—the couple on either end of a
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2.1 ASTM Standards:
textile strip of unit width bent into unit curvature.
D747 Test Method for Apparent Bending Modulus of Plas-
3.2.6 machine direction, MD, n—the direction in the plane
tics by Means of a Cantilever Beam
of the textile parallel to the direction of manufacture, analo-
D1388 Test Method for Stiffness of Fabrics
gous to the warp direction for knit and woven textiles.
F1635 Test Method for in vitro Degradation Testing of
3.2.7 weight, n—with regard to textiles, mass per unit area.
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4. Summary of Test Method
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
4.1 A specimen is slid at a specified rate in a direction
F04.15 on Material Test Methods.
parallel to its long dimension, until its leading edge projects
Current edition approved Aug. 1, 2017. Published September 2017. DOI:
10.1520/F3260-17.
from the edge of a horizontal surface. The length of the
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
overhang is measured when the tip of the specimen is de-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
pressed under its own mass to the point where the line joining
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. the top to the edge of the platform makes a 0.724 rad (41.5°)
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F3260 − 17
angle with the horizontal. From this measured length and the specimens to curl or twist can affect the result through the
specimen’s weight, the be
...
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