ASTM F2458-05
(Test Method)Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
SIGNIFICANCE AND USE
Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures either as adjuncts to sutures and staples, or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient specific circumstances, all uses involve to some extent the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given adhesive composition can provide a useful means of determining product consistency for quality control or as a means for determining the effects of various surface treatments on the substrate prior to use of the device.
The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure, which itself may vary depending on physical site and clinical intention) is such that the results of a single tensile strength test is not suitable for determining allowable design stresses without thorough analysis and understanding of the application, adhesive behaviors, and clinical indications.
This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue, mode of failure, and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.
A correlation of the test method results with actual adhesive performance in live human tissue has not been established.
SCOPE
1.1 This test method covers a means for comparison of wound closure strength of tissue adhesives used to help secure the apposition of soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of medical devices used as tissue adhesives.
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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Designation:F2458–05
Standard Test Method for
Wound Closure Strength of Tissue Adhesives and Sealants
This standard is issued under the fixed designation F2458; 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 3.1.6 adhesive failure—failure of the adhesive/substrate
bond.
1.1 This test method covers a means for comparison of
3.1.7 substrate failure—failure of the tissue substrate.
wound closure strength of tissue adhesives used to help secure
the apposition of soft tissue. With the appropriate choice of
4. Significance and Use
substrate, it may also be used for purposes of quality control in
4.1 Materials and devices that function at least in part by
the manufacture of medical devices used as tissue adhesives.
adhering to living tissues are finding increasing use in surgical
1.2 This standard does not purport to address all of the
procedures either as adjuncts to sutures and staples, or as frank
safety concerns, if any, associated with its use. It is the
replacements for those devices in a wide variety of medical
responsibility of the user of this standard to establish appro-
procedures. While the nature and magnitude of the forces
priate safety and health practices and determine the applica-
involvedvariesgreatlywithindicationandwithpatientspecific
bility of regulatory limitations prior to use.
circumstances, all uses involve to some extent the ability of the
2. Referenced Documents material to resist imposed mechanical forces. Therefore, the
mechanical properties of the materials, and in particular the
2.1 ASTM Standards:
adhesive properties, are important parameters in evaluating
D907 Terminology of Adhesives
their fitness for use. In addition, the mechanical properties of a
E4 Practices for Force Verification of Testing Machines
given adhesive composition can provide a useful means of
2.2 Other Document:
determining product consistency for quality control or as a
American Association of Tissue Banking, Standards for
means for determining the effects of various surface treatments
Tissue Banking
on the substrate prior to use of the device.
3. Terminology 4.2 The complexity and variety of individual applications
for tissue adhesive devices, even within a single indicated use
3.1 Definitions—Many terms in this test method are defined
(surgical procedure, which itself may vary depending on
in Terminology D907.
physical site and clinical intention) is such that the results of a
3.1.1 tissue adhesive—any material used as a medical
single tensile strength test is not suitable for determining
device to help secure the apposition of two wound edges or
allowable design stresses without thorough analysis and under-
opposed soft tissues.
standing of the application, adhesive behaviors, and clinical
3.1.2 tissue sealant—a surface coating with adequate adhe-
indications.
sive strength to prevent leakage of body fluids.
4.3 This test method may be used for comparing adhesives
3.1.3 cohesive strength—internal strength of the adhesive.
or bonding processes for susceptibility to fatigue, mode of
3.1.4 adhesive strength—the strength of the tissue adhesive/
failure,andenvironmentalchanges,butsuchcomparisonsmust
substrate interface.
be made with great caution since different adhesives may
3.1.5 cohesive failure—failure of the internal adhesive
respond differently to varying conditions.
bond.
4.4 A correlation of the test method results with actual
adhesive performance in live human tissue has not been
This test method is under the jurisdiction ofASTM Committee F04 on Medical
established.
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
5. Apparatus
Current edition approved Mar. 1, 2005. Published March 2005. DOI: 10.1520/
F2458-05.
5.1 Testing Machine—A testing machine of the constant-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
rate-of-crosshead-movement type and comprising essentially
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 following:
the ASTM website.
5.1.1 Fixed Member—A fixed or essentially stationary
Available from American Association of Tissue Banks (AATB), 1320 Old
member carrying one grip.
Chain Bridge Rd., Suite 450, McLean, VA 22101.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2458–05
5.1.2 Movable Member—A movable member carrying a 6. Test Substrate
second grip.
6.1 For Comparative Testing—Either fresh or frozen split
5.1.3 Grips—Grips for holding the test specimen between
thickness porcine skin graft may be used.
the fixed member and the movable member of the testing
6.1.1 Frozen split thickness porcine skin that has been
machine can be either the fixed or self-aligning type. Gripping
aseptically prepared is available commercially and is preferred
pressure should be adjustable to prevent damage to the
due to ease of use and the potential for more consistent
substrate and the use of sandpaper or plastic scrubbing pads
properties.Itshouldbethawedaccordingtothemanufacturer’s
between the gripping surfaces and the substrate is recom-
instructions prior to use. Unused graft may be kept at 2 to 8°C
mended to help prevent slippage.
for up to two weeks after thawing.
5.1.3.1 Fixed grips are rigidly attached to the fixed and
6.1.2 Iffreshskinischosen,itshouldbepreparedaccording
movable members of the testing machine. When this type of
the method in Appendix X1.
gripisused,extremecareshouldbetakentoensurethatthetest
6.2 For Application Specific Testing—The grips of the test
specimen is inserted and clamped so that the long axis of the
machine must be able to hold the tissue without having the
test specimen coincides with the direction of pull through the
tissue slip or be crushed by the grips. Some tissue (liver, lung)
centerline of the grip assembly.
may not be suitable for this test.
5.1.3.2 Self-aligning grips are attached to the fixed and
6.2.1 The strength of any adhesive is highly dependent on
movable members of the testing machine in such a manner that
the test substrate or adherend. For a specific application, the
they will move freely into alignment as soon as any load is
preferred substrate is freshly harvested tissue from the target
applied so that the long axis of the test specimen will coincide
organ of a domestic food animal. Tissue from bovine, porcine,
with the direction of the applied pull through the center line of
orovineoriginispreferredduetowideavailabilityandthefact
the grip assembly. The specimens should be aligned as per-
that relatively large samples of tissue can be harvested from a
fectly as possible with the direction of pull so that no rotary
single source. Ideally, the tissue should be used within 24 h of
motion that may induce slippage or damage to the sample will
harvest and should be kept between 5 and 10°C prior to testing
occur in the grips; there is a limit to the amount of misalign-
if it cannot be used immediately after harvesting. Storage and
ment self-aligning grips will accommodate.
handling of tissue samples should be carried out according to
5.1.4 Drive Mechanism—A drive mechanism for imparting
the guidelines set forth in Standards for Tissue Banking by the
to the movable member a uniform, controlled velocity with
American Association of Tissue Banks. The specimens should
respect to the stationary member, with this velocity to be
be brought to the test temperature or other prescribed tempera-
regulated as specified in 8.3.
ture (such as body temperature) prior to application of the
5.1.5 Load Indicator—A suitable load-indicating mecha-
adhesive.
nism capable of showing the total tensile load carried by the
6.2.2 Fixed tissue should not be used since it has been
test specimen when held by the grips.This mechanism shall be
demonstrated that fixatives cause large alterations in the
essentially free of inertia lag at the specified rate of testing and
mechanical properties of the tissue and it is probable that the
shall indicate the load with an accuracy of 61 % of the
adhesive strength would be affected as well.
indicated value, or better. The accuracy of the testing machine
shall be verified in accordance with Practices E4. 6.2.3 If the target organ is of a size or geometry that does
5.2 Temperature-controlling Equipment—Capable of main- notallowfabricationoftestsamplesasshowninFig.1,atissue
taining the test temperature to 62°C. If ambient laboratory of similar origin but larger size should be used. For example, if
conditions are employed, the same degree of control is re- the intended indication is for anastomosis of small blood
quired. vessels, a larger vessel should be substituted.
FIG. 1 Test Specimen Top View
F2458–05
6.2.4 The thickness of the tissue sample should not exceed By keeping the adhesive within the required bond area (0.5 cm
5 mm. on either side of the join line), thickness may be controlled by
6.3 For Quality Control Testing: applying a predetermined volume of adhesive.
6.3.1 For testing that is undertaken as part of a quality 8.3 After the adhesive has cured, measure and record the
control process in the manufacturing of a tissue adhesive width and length of the adhesive bond to within 0.05 cm.
device, the use of freshly harvested tissue is highly inconve- 8.4 Re-cover the tissue with gauze soaked in PBS, replace
nient and may also lead to unacceptable variation in the test the sample in a plastic bag, and return it to the constant
results, especially if the failure occurs in the adherend (sub- temperature environment.Adhesives should be allowed to cure
strate failure). Since the purpose of quality control testing is to according to the IFU and for a minimum of 15 min.
demonstrate consistency in the device, substitution of a model
9. Procedure
substrate is preferred so long as it is d
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