Standard Test Method for Strength Properties of Tissue Adhesives in Tension

SIGNIFICANCE AND USE
4.1 The utility, range, and efficacy of adhesives in clinical medicine are well documented in the literature. Whether being used as an adhesive, hemostatic, sealant, or carrier for drugs or growth factors, or both, the scope of adhesive use in clinical medicine continues to expand. There are several factors which are vital to the success and efficacy of a medical tissue adhesive including, (1) adequate tissue bonding strength, (2) tissue compatibility, (3) acceptable biodegradable properties when the adhesive is used internally, (4) availability, (5) ease of application, and (6) cost.  
4.2 Medical adhesives are currently used for a variety of applications and tissue types. Applications range from fixation of external tissues to internal application for use with either similar or dissimilar opposing surfaces. While the biological or chemical makeup, or both, of the adhesive may define its characteristics, additional mechanical factors including adhesive volume or method of application, or both, may also contribute significantly toward the performance of the adhesive. In an effort to fairly and adequately quantify adhesive bonding strength for medical adhesives, it is important to develop a consistent, reproducible testing standard for evaluative and comparative purposes. Due to the fact that the adhesives will be used on or in living tissues, a readily available biological testing surface is preferred.  
4.3 The data generated from a standardized testing method on biologic tissue may vary from that found in vivo, however, testing results should offer valuable information on the potential bonding capacity and for the preparation of subsequent in vivo experiments.  
4.4 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 tensile test are not suitable for determining allowable design stresses without thorough analysis and understanding of the applica...
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.

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Published
Publication Date
30-Apr-2015
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ASTM F2258-05(2015) - Standard Test Method for Strength Properties of Tissue Adhesives in Tension
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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: F2258 − 05 (Reapproved 2015)
Standard Test Method for
1
Strength Properties of Tissue Adhesives in Tension
This standard is issued under the fixed designation F2258; 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 for use in closing wounds (surgical or traumatic) or for sealing
against leakage of body fluids.
1.1 This test method is intended to provide a means for
3.2.2 tissue sealant—a surface coating with adequate adhe-
comparison of the adhesive strengths of tissue adhesives
sive strength to prevent leakage of body fluids.
intended for use as surgical adhesives or sealants, or both, on
softtissue.Withtheappropriatechoiceofsubstrate,itmayalso
4. Significance and Use
be used for purposes of quality control in the manufacture of
4.1 The utility, range, and efficacy of adhesives in clinical
tissue adhesive based medical devices.
medicine are well documented in the literature.Whether being
1.2 The values stated in SI units are to be regarded as
usedasanadhesive,hemostatic,sealant,orcarrierfordrugsor
standard. No other units of measurement are included in this
growth factors, or both, the scope of adhesive use in clinical
standard.
medicine continues to expand. There are several factors which
1.3 This standard does not purport to address all of the
arevitaltothesuccessandefficacyofamedicaltissueadhesive
safety concerns, if any, associated with its use. It is the
including, (1) adequate tissue bonding strength, (2) tissue
responsibility of the user of this standard to establish appro-
compatibility, (3) acceptable biodegradable properties when
priate safety and health practices and determine the applica-
the adhesive is used internally, (4) availability, (5) ease of
bility of regulatory limitations prior to use.
application, and (6) cost.
4.2 Medical adhesives are currently used for a variety of
2. Referenced Documents
applications and tissue types.Applications range from fixation
2
2.1 ASTM Standards:
of external tissues to internal application for use with either
D907Terminology of Adhesives
similarordissimilaropposingsurfaces.Whilethebiologicalor
E4Practices for Force Verification of Testing Machines
chemical makeup, or both, of the adhesive may define its
3
2.2 American Association of Tissue Banks Standards:
characteristics, additional mechanical factors including adhe-
Standards for Tissue Banking
sive volume or method of application, or both, may also
contribute significantly toward the performance of the adhe-
3. Terminology
sive. In an effort to fairly and adequately quantify adhesive
3.1 Definitions—Many terms in this test method are defined
bonding strength for medical adhesives, it is important to
in Terminology D907.
develop a consistent, reproducible testing standard for evalua-
tive and comparative purposes. Due to the fact that the
3.2 Definitions:
adhesives will be used on or in living tissues, a readily
3.2.1 tissue adhesive—for the purposes of this test method,
available biological testing surface is preferred.
tissue adhesive is defined as a compound or system intended
4.3 The data generated from a standardized testing method
on biologic tissue may vary from that found in vivo, however,
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
testing results should offer valuable information on the poten-
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
tial bonding capacity and for the preparation of subsequent in
F04.15 on Material Test Methods.
vivo experiments.
CurrenteditionapprovedMay1,2015.PublishedJuly2015.Originallyapproved
in 2003. Last previous edition approved in 2010 as F2258–05 (2010). DOI:
4.4 The complexity and variety of individual applications
10.1520/F2258-05R15.
2
for tissue adhesive devices, even within a single indicated use
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
(surgicalprocedure),issuchthattheresultsofatensiletestare
Standards volume information, refer to the standard’s Document Summary page on
not suitable for determining allowable design stresses without
the ASTM website.
3 thorough analysis and understanding of the application and
Available from the American Association of Tissue Banks (AATB), 1350
adhesive behaviors.
Beverly Rd., Suite 220-A, McLean, VA 22101.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-
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