The purpose of this work item is to conduct a study that establishes, with empirical data, a correlation between the result of a seal strength test conducted per the process described in ASTM F88 using a test strip width of 1 inch to the result of the same test conducted using a 15 millimeter (mm) test strip width. When establishing and verifying requirements for seal strength of medical device sterile barrier systems, many manufacturers are utilizing FDA Consensus Standard ASTM F88:2009 for conducting a seal strength measurement. The test method references three widths, 25mm, 15mm or 25.4mm (1 inch). Despite allowances for 3 distinct widths, all ILS data presented in the standard is produced using the 1 inch width. In Europe, a harmonized standard (EN 868-5: 2009), which is recognized to be state of the art only references a 15mm test strip. In recent years, European notified bodies have made inquiries as to the applicability of data gathered per ASTM F88 using a 1 inch test strip in relation to their requirement of the 15mm test strip. This exercise is designed to address those inquiries in a comprehensive manner and include the result of the study in the next update to the standard.
KeywordsFlexible barrier materials; Sealability; Seal strength;
Draft Under Development