ASTM F2256-03
(Test Method)Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
SCOPE
1.1 This test method is intended to provide a means for comparison of the adhesive strengths of tissue adhesives intended for use as surgical adhesives or sealants, or both, on soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of tissue adhesive based medical devices.
1.2 The values stated in SI units are to be regarded as the standard.
1.3 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: F 2256 – 03
Standard Test Method for
Strength Properties of Tissue Adhesives in T-Peel by
Tension Loading
This standard is issued under the fixed designation F 2256; 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 adhesive—for the purposes of this test method,
tissue adhesive is defined as a compound or system intended
1.1 This test method is intended to provide a means for
for use in closing wounds (surgical or traumatic) or for sealing
comparison of the adhesive strengths of tissue adhesives
against leakage of body fluids.
intended for use as surgical adhesives or sealants, or both, on
3.2.3 tissue sealant—a surface coating with adequate adhe-
softtissue.Withtheappropriatechoiceofsubstrate,itmayalso
sive strength to prevent leakage of body fluids.
be used for purposes of quality control in the manufacture of
3.2.4 T-peel strength—the average load per unit width of
tissue adhesive based medical devices.
bond line required to produce progressive separation of two
1.2 The values stated in SI units are to be regarded as the
bonded flexible adherends, under conditions designated in this
standard.
method.
1.3 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
4. Significance and Use
responsibility of the user of this standard to establish appro-
4.1 Materials and devices that function at least in part by
priate safety and health practices and determine the applica-
adhering to living tissues are finding increasing use in surgical
bility of regulatory limitations prior to use.
procedures either as adjuncts to sutures and staples, or as frank
2. Referenced Documents replacements for those devices in a wide variety of medical
procedures. While the nature and magnitude of the forces
2.1 ASTM Standards:
involvedvariesgreatlywithindicationandwithpatientspecific
D 907 Terminology of Adhesives
circumstances, all uses involve to some extent the ability of the
D 1876 Test Method for Peel Resistance of Adhesives
material to resist imposed mechanical forces. Therefore, the
(T-Peel Test)
mechanical properties of the materials, and in particular the
E 4 Practices for Force Verification of Testing Machines
4 adhesive properties, are important parameters in evaluating
2.2 American Association of Tissue Banks Standards:
their fitness for use. In addition, the mechanical properties of a
Standards for Tissue Banking
given adhesive composition can provide a useful means of
3. Terminology
determining product consistency for quality control, or as a
means for determining the effects of various surface treatments
3.1 Definitions—Many terms in this test method are defined
on the substrate prior to use of the device.
in Terminology D 907.
4.2 The complexity and variety of individual applications
3.2 Definitions:
for tissue adhesive devices, even within a single indicated use
3.2.1 flexible—as used in this test method, indicates that the
(surgical procedure) is such that the results of a T-Peel test are
adherends shall have such dimensions and physical properties
not suitable for determining allowable design stresses without
as to permit bending them through any angle up to 90° without
thorough analysis and understanding of the application and
breaking or cracking.
adhesive behaviors.
4.3 This test method may be used for comparing adhesives
This test method is under the jurisdiction ofASTM Committee F04 on Medical
or bonding processes for susceptibility to fatigue and environ-
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
mentalchanges,butsuchcomparisonsmustbemadewithgreat
F04.15 on Material Test Methods.
Current edition approved Apr. 10, 2003. Published May 2003. caution since different adhesives may respond differently to
Annual Book of ASTM Standards, Vol 15.06.
varying conditions.
Annual Book of ASTM Standards, Vol 03.01.
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.
F2256–03
5. Apparatus preferred substrate is freshly harvested tissue from the target
organ of a domestic food animal. Tissue from bovine, porcine,
5.1 Testing Machine, of the constant-rate-of-crosshead-
orovineoriginispreferredduetowideavailabilityandthefact
movement type and comprising essentially the following:
that relatively large samples of tissue can be harvested from a
5.1.1 Fixed Member, a fixed or essentially stationary mem-
single source. Ideally, the tissue should be used within 24 h of
ber carrying one grip.
harvest,andshouldbekeptbetween5and10°Cpriortotesting
5.1.2 Movable Member, a movable member carrying a
if it cannot be used immediately after harvesting. Storage and
second grip.
handling of tissue samples should be carried out according to
5.1.3 Grips, for holding the test specimen between the fixed
the guidelines set forth in Standards for Tissue Banking by the
member and the movable member of the testing machine can
American Association of Tissue Banks. The specimens should
be either the fixed or self-aligning type.
be brought to the test temperature or other prescribed tempera-
5.1.3.1 Fixed Grips are rigidly attached to the fixed and
ture (such as body temperature) prior to application of the
movable members of the testing machine. When this type of
adhesive.
grip is used extreme care should be taken to ensure that the test
6.2.2 Fixed tissue should not be used since it has been
specimen is inserted and clamped so that the long axis of the
demonstrated that fixatives cause large alterations in the
test specimen coincides with the direction of pull through the
mechanical properties of the tissue and it is probable that the
centerline of the grip assembly.
adhesive strength would be affected as well.
5.1.3.2 Self-Aligning Grips are attached to the fixed and
6.2.3 Ifthetargetorganisofasizeorgeometry,orboth,that
movable members of the testing machine in such a manner that
does not allow fabrication of test samples as shown in Fig. 1,
they will move freely into alignment as soon as any load is
a tissue of similar origin but larger size should be used. For
applied so that the long axis of the test specimen will coincide
example, if the intended indication is for anastomosis of small
with the direction of the applied pull through the center line of
blood vessels, a larger vessel should be substituted (see 6.2).
the grip assembly. The specimens should be aligned as per-
6.2.4 The thickness of the tissue sample should be mini-
fectly as possible with the direction of pull so that no rotary
mized and should not exceed 5 mm. Thicker samples will lead
motion that may induce slippage or damage to the sample will
to distortion of the substrate and mixed loading (shear and
occur in the grips; there is a limit to the amount of misalign-
tension). It is also important that the thickness be as uniform as
ment self-aligning grips will accommodate.
possible.
5.1.4 Drive Mechanism, for imparting to the movable mem-
6.3 Substrates for Quality Control Testing:
ber a uniform, controlled velocity with respect to the stationary
6.3.1 For testing that is undertaken as part of a quality
member, with this velocity to be regulated as specified in 9.3.
control process in the manufacturing of a tissue adhesive
5.1.5 Load Indicator, a suitable load-indicating mechanism
device, the use of freshly harvested tissue is highly inconve-
capable of showing the total tensile load carried by the test
nient and may also lead to unacceptable variation in the test
specimen when held by the grips. This mechanism shall be
results, especially if the failure occurs in the adherend (sub-
essentially free of inertia lag at the specified rate of testing and
strate failure). Since the purpose of quality control testing is to
shall indicate the load with an accuracy of 61 % of the
demonstrate consistency in the device, substitution of a model
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
conditionsareemployedthesamedegreeofcontrolisrequired.
Awaterbathorenvironmentalchambercapableofmaintaining
37°C is required for testing on tissue substrates.
6. Test Substrate
6.1 For comparative testing: Mediskin
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