ASTM F2256-05
(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
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) is such that the results of a T-Peel test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and adhesive behaviors.
This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.
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: F2256 – 05
Standard Test Method for
Strength Properties of Tissue Adhesives in T-Peel by
1
Tension Loading
This standard is issued under the fixed designation F2256; 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 3.2.2 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
2
procedures. While the nature and magnitude of the forces
2.1 ASTM Standards:
involvedvariesgreatlywithindicationandwithpatientspecific
D907 Terminology of Adhesives
circumstances, all uses involve to some extent the ability of the
E4 Practices for Force Verification of Testing Machines
3
material to resist imposed mechanical forces. Therefore, the
2.2 American Association of Tissue Banks Standards:
mechanical properties of the materials, and in particular the
Standards for Tissue Banking
adhesive properties, are important parameters in evaluating
3. Terminology
their fitness for use. In addition, the mechanical properties of a
given adhesive composition can provide a useful means of
3.1 Definitions—Many terms in this test method are defined
determining product consistency for quality control, or as a
in Terminology D907.
means for determining the effects of various surface treatments
3.2 Definitions:
on the substrate prior to use of the device.
3.2.1 flexible—as used in this test method, indicates that the
4.2 The complexity and variety of individual applications
adherends shall have such dimensions and physical properties
for tissue adhesive devices, even within a single indicated use
as to permit bending them through any angle up to 90° without
(surgical procedure) is such that the results of a T-Peel test are
breaking or cracking.
not suitable for determining allowable design stresses without
thorough analysis and understanding of the application and
adhesive behaviors.
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This test method is under the jurisdiction ofASTM Committee F04 on Medical
4.3 This test method may be used for comparing adhesives
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
or bonding processes for susceptibility to fatigue and environ-
Current edition approved Mar. 1, 2005. Published March 2005. Originally
mentalchanges,butsuchcomparisonsmustbemadewithgreat
approved in 2003. Last previous edition approved in 2003 as F2256 – 03. DOI:
caution since different adhesives may respond differently to
10.1520/F2256-05.
2
varying conditions.
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
5. Apparatus
the ASTM website.
3
5.1 Testing Machine, of the constant-rate-of-crosshead-
Available from the American Association of Tissue Banks (AATB), 1350
Beverly Rd., Suite 220-A, McLean, VA 22101. movement type and comprising essentially the following:
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2256 – 05
5.1.1 Fixed Member, a fixed or essentially stationary mem- singl
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