New Test Method for To Assess Surgical Sealant Coverage Area
1. Scope
This test method describes the procedure for determining the two-dimensional (2D) areal coverage of surgical sealant onto a substrate during controlled relative motion between a dispensing mechanism and a receiving surface substrate. This test is intended to simulate aspects of a clinical application of a delivery device sealant that is dispensed over a target surface under motion. The collected sealant material on a substrate is subsequently quantified to determine the extent of the two-dimensional areal coverage of the sealant. This method may be used for comparative evaluation of products intended for the same application, provided that dispensing rates and dispensed volumes are matched to maintain equivalent test conditions
Keywords
Sealant; Spray; Coverage Area
Rationale
Currently there are no applicable ASTM standards for determining two-dimensional areal coverage of surgical sealants. As a result, this work item is created to address this need with the creation of a new standard that provides the instructions for determining two-dimensional areal coverage of surgical sealants.
