Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants

Importancia y uso:

4.1 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 vary 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.

4.2 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.

4.3 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.

4.4 A correlation of the test method results with actual adhesive performance in live human tissue has not been established.

Subcomité:

F04.15

Volúmen:

13.01

Número ICS:

11.120.20 (Wound dressings. Compresses)

Palabras clave:

adhesive strength; cohesive strength; tissue adhesive; wound closure strength;