【国外标准】 Standard Test Method for Strength Properties of Tissue Adhesives in Tension

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 application and adhesive behaviors.4.5 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.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.