ASTM F2256-05(2015)

Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading

SIGNIFICANCE AND USE
4.1 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.  
4.2 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.  
4.3 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 standard. No other units of measurement are included in this 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.

General Information

• Status: Published
• Publication Date: 30-Apr-2015
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 83.180 - Adhesives
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Refers: ASTM E4-14 - Standard Practices for Force Verification of Testing Machines
• Effective Date: 01-Jun-2014
• Referred By: ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
• Effective Date: 01-May-2015

Standards Content (Sample)

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.
Designation: F2256 −05 (Reapproved 2015)
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.Anumber 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
tissue adhesive based medical devices.
3.2.4 T-peel strength—the average load per unit width of
bond line required to produce progressive separation of two
1.2 The values stated in SI units are to be regarded as
bonded flexible adherends, under conditions designated in this
standard. No other units of measurement are included in this
method.
standard.
1.3 This standard does not purport to address all of the
4. Significance and Use
safety concerns, if any, associated with its use. It is the
4.1 Materials and devices that function at least in part by
responsibility of the user of this standard to establish appro-
adhering to living tissues are finding increasing use in surgical
priate safety and health practices and determine the applica-
procedureseitherasadjunctstosuturesandstaples,orasfrank
bility of regulatory limitations prior to use.
replacements for those devices in a wide variety of medical
procedures. While the nature and magnitude of the forces
2. Referenced Documents
involvedvariesgreatlywithindicationandwithpatientspecific
2
2.1 ASTM Standards:
circumstances,allusesinvolvetosomeextenttheabilityofthe
D907Terminology of Adhesives
material to resist imposed mechanical forces. Therefore, the
E4Practices for Force Verification of Testing Machines
mechanical properties of the materials, and in particular the
3
2.2 American Association of Tissue Banks Standards:
adhesive properties, are important parameters in evaluating
Standards for Tissue Banking
their fitness for use. In addition, the mechanical properties of a
given adhesive composition can provide a useful means of
3. Terminology
determining product consistency for quality control, or as a
3.1 Definitions—Many terms in this test method are defined
meansfordeterminingtheeffectsofvarioussurfacetreatments
in Terminology D907.
on the substrate prior to use of the device.
3.2 Definitions:
4.2 The complexity and variety of individual applications
3.2.1 flexible—as used in this test method, indicates that the
for tissue adhesive devices, even within a single indicated use
adherends shall have such dimensions and physical properties
(surgical procedure) is such that the results of a T-Peel test are
astopermitbendingthemthroughanyangleupto90°without
not suitable for determining allowable design stresses without
breaking or cracking.
thorough analysis and understanding of the application and
adhesive behaviors.
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee 4.3 This test method may be used for comparing adhesives
F04.15 on Material Test Methods.
or bonding processes for susceptibility to fatigue and environ-
CurrenteditionapprovedMay1,2015.PublishedJuly2015.Originallyapproved
mentalchanges,butsuchcomparisonsmustbemadewithgreat
in 2003. Last previous edition approved in 2010 as F2256–05 (2010). DOI:
caution since different adhesives may respond differently to
10.1520/F2256-05R15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
varying conditions.
contact ASTM Customer Service at [e-mail]. 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:
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