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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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D907 Terminology of Adhesives
American Association for Tissue Banks (AATB) StandardStandardsforTissueBa Available from American Association for Tissue Banks (AATB), 1320 Old Chain Bridge Rd., Suite 450, McLean, VA 22101.
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42312005(Medical adhesives or glues for skin closure)