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ASTM F2458-05(2010)

(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.
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
Historical
Publication Date
31-May-2010
ICS
11.120.20 - Wound dressings and compresses
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Replaces
ASTM F2458-05 - Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
Effective Date
01-Jun-2010
Replaced By
ASTM F2458-05(2015) - Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
Effective Date
01-May-2015

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ASTM F2458-05(2010) - Standard Test Method for Wound Closure Strength of Tissue Adhesives and SealantsASTM F2458-05(2010) - Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
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ASTM F2458-05(2010) - Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2458 − 05(Reapproved 2010)
Standard Test Method for
1
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.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 sealant—a surface coating with adequate adhe-
sive strength to prevent leakage of body fluids.
1.1 This test method covers a means for comparison of
3.2.3 cohesive strength—internal strength of the adhesive.
wound closure strength of tissue adhesives used to help secure
the apposition of soft tissue. With the appropriate choice of
3.2.4 adhesive strength—the strength of the tissue adhesive/
substrate,itmayalsobeusedforpurposesofqualitycontrolin
substrate interface.
the manufacture of medical devices used as tissue adhesives.
3.2.5 cohesivefailure—failureoftheinternaladhesivebond.
1.2 The values stated in SI units are to be regarded as
3.2.6 adhesive failure—failure of the adhesive/substrate
standard. No other units of measurement are included in this
bond.
standard.
3.2.7 substrate failure—failure of the tissue substrate.
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.
procedureseitherasadjunctstosuturesandstaples,orasfrank
replacements for those devices in a wide variety of medical
2. Referenced Documents
procedures. While the nature and magnitude of the forces
2
involvedvariesgreatlywithindicationandwithpatientspecific
2.1 ASTM Standards:
D907Terminology of Adhesives circumstances,allusesinvolvetosomeextenttheabilityofthe
material to resist imposed mechanical forces. Therefore, the
E4Practices for Force Verification of Testing Machines
mechanical properties of the materials, and in particular the
2.2 Other Document:
adhesive properties, are important parameters in evaluating
American Association of Tissue Banking,Standards for
3 their fitness for use. In addition, the mechanical properties of a
Tissue Banking
given adhesive composition can provide a useful means of
determining product consistency for quality control or as a
3. Terminology
meansfordeterminingtheeffectsofvarioussurfacetreatments
3.1 Many terms in this test method are defined inTerminol-
on the substrate prior to use of the device.
ogy D907.
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 tissue adhesive—any material used as a medical de-
(surgical procedure, which itself may vary depending on
vice to help secure the apposition of two wound edges or
physical site and clinical intention) is such that the results of a
opposed soft tissues.
single tensile strength test is not suitable for determining
allowabledesignstresseswithoutthoroughanalysisandunder-
standing of the application, adhesive behaviors, and clinical
1
indications.
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, mode of
Current edition approved June 1, 2010. Published September 2010. Originally
approved in 2005. Last previous edition approved in 2005 as F2458-05. DOI:
failure,andenvironmentalchanges,butsuchcomparisonsmust
10.1520/F2458-05R10.
be made with great caution since different adhesives may
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
respond differently to varying conditions.
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
4.4 A correlation of the test method results with actual
the ASTM website.
3
adhesive performance in live human tissue has not been
Available from American Association of Tissue Banks (AATB), 1320 Old
Chain Bridge Rd., Suite 450, McLean, VA 22101. established.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2458 − 05 (2010)
5. Apparatus 6.2 For Application Specific Testing—The grips of the test
machine must be able to hold the tissue without
...

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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.  
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