Work Item
ASTM WK89736
New Guide for Benchtop Evaluation of Seal Zone Leakage of Endovascular Prostheses
1. Scope
Provide a guide to evaluate the seal zone leak rate of a device that satisfies ISO 25539-1 part D.5.2.4.1Keywords
in vitro; seal zone; proximal seal; distal seal; benchtop; leakageRationale
Seal zone leakage testing is referenced in other standards at a high level but no standard exists that details out methodology and considerations for the test. The test is currently being performed as part of medical device development and testing. Likely R&D or NPD quality engineers, or testing contractor will be performing the testing in support of design verification or development.
Work Item Status
Date Initiated: 02-21-2024
Technical Contact: Lucas Chavez-Pardini
Item: 000
Ballot:
Status: