ASTM F2392-04(2010)
(Test Method)Standard Test Method for Burst Strength of Surgical Sealants
Standard Test Method for Burst Strength of Surgical 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 and cohesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given sealant 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 sealant, even within a single indicated use (surgical procedure), is such that the results of a burst test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and sealant behaviors.
This test method may be used for comparing sealants for susceptibility to environmental changes, but such comparisons must be made with great caution since different sealants may respond differently to varying conditions.
As the true sealant strength is strongly dependent on the strength of the sealant/substrate interface, the selection of a proper test substrate is critical. Care must be taken when extrapolating in vitro test results to in vivo expectations. In vitro sealant optimization may not translate to expected in vivo performance due to differences in substrate surface, strength, and elasticity.
SCOPE
1.1 This test method provides a means for comparison of the burst or rupture strength of sealants on soft tissue. This test method can be used as a clinically relevant model for quality assurance, development, and comparative testing of different adhesives or adherends.
1.2 This test method measures only burst strength or “cohesive strength” of an adhesive/adherend system, and not the adhesive strength.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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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Standards Content (Sample)
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Designation: F2392 − 04(Reapproved 2010)
Standard Test Method for
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Burst Strength of Surgical Sealants
This standard is issued under the fixed designation F2392; 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 burst strength—the average pressure required to cause
failure of the sealant, either by cohesive or adhesive mecha-
1.1 Thistestmethodprovidesameansforcomparisonofthe
nisms.
burst or rupture strength of sealants on soft tissue. This test
3.2.3 cohesive failure—failure of the sealant during burst
method can be used as a clinically relevant model for quality
testing.
assurance, development, and comparative testing of different
adhesives or adherends.
3.2.4 cohesive strength—the internal strength of the sealant,
sometimes referred to as the adhesive bulk strength.
1.2 This test method measures only burst strength or “co-
hesive strength” of an adhesive/adherend system, and not the
3.2.5 substrate failure—failure of the substrate during burst
adhesive strength.
testing.
1.3 The values stated in SI units are to be regarded as 3.2.6 tissue sealant—a surface coating to prevent leakage of
standard. No other units of measurement are included in this body fluids.
standard.
4. Significance and Use
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the 4.1 Materials and devices that function at least in part by
adhering to living tissues are finding increasing use in surgical
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica- procedures, either as adjuncts to sutures and staples or as frank
replacements for those devices in a wide variety of medical
bility of regulatory limitations prior to use.
procedures. While the nature and magnitude of the forces
2. Referenced Documents
involvedvariesgreatlywithindicationandwithpatientspecific
2
circumstances, all uses involve, to some extent, the ability of
2.1 ASTM Standards:
thematerialtoresistimposedmechanicalforces.Therefore,the
D907 Terminology of Adhesives
mechanical properties of the materials, and in particular the
2.2 American Association for Tissue Banks (AATB) Stan-
adhesive and cohesive properties, are important parameters in
dard:
3
evaluating their fitness for use. In addition, the mechanical
Standards for Tissue Banking
properties of a given sealant composition can provide a useful
3. Terminology means of determining product consistency for quality control,
or as a means for determining the effects of various surface
3.1 Definitions—Many terms in this test method are defined
treatments on the substrate prior to use of the device.
in Terminology D907.
4.2 The complexity and variety of individual applications
3.2 Definitions:
for sealant, even within a single indicated use (surgical
3.2.1 adhesive failure—failure of the sealant/substrate inter-
procedure), is such that the results of a burst test are not
face during burst testing.
suitable for determining allowable design stresses without
thorough analysis and understanding of the application and
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sealant behaviors.
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
4.3 Thistestmethodmaybeusedforcomparingsealantsfor
F04.15 on Material Test Methods.
susceptibility to environmental changes, but such comparisons
Current edition approved Sept. 1, 2010. Published November 2010. Originally
approved in 2004. Last previous edition approved in 2004 as F2392 – 04. DOI:
must be made with great caution since different sealants may
10.1520/F2392-04R10.
respond differently to varying conditions.
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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
4.4 As the true sealant strength is strongly dependent on the
Standards volume information, refer to the standard’s Document Summary page on
strength of the sealant/substrate interface, the selection of a
the ASTM website.
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proper test substrate is critical. Care must be taken when
Available from American Association for Tissue Banks (AATB), 1320 Old
Chain Bridge Rd., Suite 450, McLean, VA 22101. extrapolating in vitro test results to in vivo expectations. In
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F2392 − 04 (2010)
vitro sealant optimization may not translate to expected in vivo that relatively
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