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Description of ASTM-F2458 2010ASTM F2458 - 05(2010)Standard Test Method for Wound Closure Strength of Tissue Adhesives and SealantsActive Standard ASTM F2458 | Developed by Subcommittee: F04.15 Book of Standards Volume: 13.01 ASTM F2458Significance 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. 1. 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.
Other Document AmericanAssociationo Standards for Tissue Banking Available from American Association of Tissue Banks (AATB), 1320 Old Chain Bridge Rd., Suite 450, McLean, VA 22101.ASTM Standards D907 Terminology of Adhesives E4 Practices for Force Verification of Testing Machines Keywords adhesive strength; cohesive strength; tissue adhesive; wound closure strength; Tissue adhesives; ICS Code ICS Number Code 11.120.20 (Wound dressings. Compresses) DOI: 10.1520/F2458-05R10 ASTM International is a member of CrossRef. ASTM F2458This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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