Provide a guide to evaluate the seal zone leak rate of a device that satisfies ISO 25539-1 part D.5.2.4.1
in vitro; seal zone; proximal seal; distal seal; benchtop; leakage
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.
The title and scope are in draft form and are under development within this ASTM Committee.
Date Initiated: 02-21-2024
Technical Contact: Lucas Chavez-Pardini
Item: 000
Ballot:
Status: