ASTM F2258-03

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F2258–03
Standard Test Method for
Strength Properties of Tissue Adhesives in Tension
This standard is issued under the fixed designation F 2258; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2.2 tissue sealant—a surface coating with adequate adhe-
sive strength to prevent leakage of body fluids.
1.1 This test method is intended to provide a means for
comparison of the adhesive strengths of tissue adhesives
4. Significance and Use
intended for use as surgical adhesives or sealants, or both, on
4.1 The utility, range, and efficacy of adhesives in clinical
softtissue.Withtheappropriatechoiceofsubstrate,itmayalso
medicine are well documented in the literature. Whether being
be used for purposes of quality control in the manufacture of
used as an adhesive, hemostatic, sealant, or carrier for drugs or
tissue adhesive based medical devices.
growth factors, or both, the scope of adhesive use in clinical
1.2 The values stated in SI units are to be regarded as the
medicine continues to expand. There are several factors which
standard.
arevitaltothesuccessandefficacyofamedicaltissueadhesive
1.3 This standard does not purport to address all of the
including, (1) adequate tissue bonding strength, (2) tissue
safety concerns, if any, associated with its use. It is the
compatibility, (3) acceptable biodegradable properties when
responsibility of the user of this standard to establish appro-
the adhesive is used internally, (4) availability, (5) ease of
priate safety and health practices and determine the applica-
application, and (6) cost.
bility of regulatory limitations prior to use.
4.2 Medical adhesives are currently used for a variety of
2. Referenced Documents applications and tissue types.Applications range from fixation
of external tissues to internal application for use with either
2.1 ASTM Standards:
similar or dissimilar opposing surfaces.While the biological or
D 897 Test Method For Tensile Properties of Adhesive
chemical makeup, or both, of the adhesive may define its
Bonds
characteristics, additional mechanical factors including adhe-
D 907 Terminology of Adhesives
sive volume or method of application, or both, may also
E 4 Practices for Force Verification of Testing Machines
4 contribute significantly toward the performance of the adhe-
2.2 American Association of Tissue Banks Standards:
sive. In an effort to fairly and adequately quantify adhesive
Standards for Tissue Banking
bonding strength for medical adhesives, it is important to
3. Terminology
develop a consistent, reproducible testing standard for evalua-
tive and comparative purposes. Due to the fact that the
3.1 Definitions—Many terms in this test method are defined
adhesives will be used on or in living tissues, a readily
in Terminology D 907.
available biological testing surface is preferred.
3.2 Definitions:
4.3 The data generated from a standardized testing method
3.2.1 tissue adhesive—for the purposes of this test method,
on biologic tissue may vary from that found in vivo, however,
tissue adhesive is defined as a compound or system intended
testing results should offer valuable information on the poten-
for use in closing wounds (surgical or traumatic) or for sealing
tial bonding capacity and for the preparation of subsequent in
against leakage of body fluids.
vivo experiments.
4.4 The complexity and variety of individual applications
This test method is under the jurisdiction ofASTM Committee F04 on Medical
for tissue adhesive devices, even within a single indicated use
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
(surgical procedure), is such that the results of a tensile test are
F04.15 on Material Test Methods.
not suitable for determining allowable design stresses without
Current edition approved Apr. 10, 2003. Published May 2003.
thorough analysis and understanding of the application and
Annual Book of ASTM Standards, Vol 15.06.
Annual Book of ASTM Standards, Vol 03.01.
adhesive behaviors.
Available from the American Association of Tissue Banks (AATB), 1350
Beverly Rd., Suite 220-A, McLean, VA 22101.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2258–03
4.5 This test method may be used for comparing adhesives er’s instructions prior to use. Unused graft may be kept at 2 to
or bonding processes for susceptibility to fatigue and environ- 8°C for up to two weeks after thawing.
mentalchanges,butsuchcomparisonsmustbemadewithgreat 6.2 Application Specific Testing:
caution since different adhesives may respond differently to 6.2.1 The strength of any adhesive is highly dependent on
varying conditions. the test substrate, or adherend. For a specific application, the
preferred substrate is freshly harvested tissue from the target
5. Apparatus
organ of a domestic food animal. Tissue from bovine, porcine,
orovineoriginispreferredduetowideavailabilityandthefact
5.1 Testing Machine, of the constant-rate-of-crosshead-
that relatively large samples of tissue can be harvested from a
movement type and comprising essentially the following:
single source. Ideally, the tissue should be used within 24 h of
5.1.1 Fixed Member, a fixed or essentially stationary mem-
harvest,andshouldbekeptbetween5and10°Cpriortotesting
ber carrying one grip.
if it cannot be used immediately after harvesting. Storage and
5.1.2 Movable Member, a movable member carrying a
handling of tissue samples should be carried out according to
second grip.
the guidelines set forth in Standards for Tissue Banking by the
5.1.3 Grips, for holding the test specimen between the fixed
American Association of Tissue Banks. The specimens should
member and the movable member of the testing machine can
be brought to the test temperature or other prescribed tempera-
be either the fixed or self-aligning type.
ture (such as body temperature) prior to application of the
5.1.3.1 Fixed Grips are rigidly attached to the fixed and
adhesive.
movable members of the testing machine. When this type of
6.2.2 Fixed tissue should not be used since it has been
gripisused,extremecareshouldbetakentoensurethatthetest
demonstrated that fixatives cause large alterations in the
specimen is inserted and clamped so that the long axis of the
mechanical properties of the tissue and it is probable that the
test specimen coincides with the direction of pull through the
adhesive strength would be affected as well.
centerline of the grip assembly.
6.2.3 Ifthetargetorganisofasizeorgeometry,orboth,that
5.1.3.2 Self-aligning Grips are attached to the fixed and
does not allow fabrication of test samples as shown in Fig. 1,
movable members of the testing machine in such a manner that
a tissue of similar origin but larger size should be used. For
they will move freely into alignment as soon as any load is
example, if the intended indication is for anastomosis of small
applied so that the long axis of the test specimen will coincide
blood vessels, a larger vessel should be substituted.
with the direction of the applied pull through the center line of
6.2.4 The thickness of the tissue sample should be mini-
the grip assembly. The specimens should be aligned as per-
mized and should not exceed 5 mm. Thicker samples will lead
fectly as possible with the direction of pull so that no rotary
to distortion of the substrate and mixed loading (shear and
motion that may induce slippage or damage to the sample will
tension). It is also important that the thickness be as uniform as
occur in the grips; there is a limit to the amount of misalign-
possible.
ment self-aligning grips will accommodate.
6.3 Substrates for Quality Control Testing:
5.1.4 Drive Mechanism, for imparting to the movable mem-
6.3.1 For testing that is undertaken as part of a quality
ber a uniform, controlled velocity with respect to the stationary
control process in the manufacturing of a tissue adhesive
member, with this velocity to be regulated as specified in 9.3.
device, the use of freshly harvested tissue is highly inconve-
5.1.5 Load Indicator, a suitable load-indicating mechanism
nient and may also lead to unacceptable variation in the test
capable of showing the total tensile load carried by the test
results, especially if the failure occurs in the adherend (sub-
specimen when held by the grips. This mechanism shall be
strate failure). Since the purpose of quality control testing is to
essentially free of inertia lag at the specified rate of testing and
demonstrate consistency in the device, substitution of a model
shall indicate the load with an accuracy of 61 % of the
indicated value, or better. The accuracy of the testing machine
shall be verified in accordance with Practices E 4.
5.2 Temperature-controlling Equipment, capable of main-
taining the test temperature to 62°C. If ambient laboratory
conditions are employed, the same degree of control is re-
quired. A water bath or environmental chamber capable of
maintaining 37°C is required for testing on tissue substrates.
6. Test Substrate
6.1 For comparative testing: Mediskin Xenograft (Cat
#102) should be used. It is a split thickness porcine skin graf
...