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.5.2.4.1

Keywords

in vitro; seal zone; proximal seal; distal seal; benchtop; leakage

Rationale

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.

Details

Developed by Subcommittee: F04.30

Committee: F04

Staff Manager: Kate Chalfin

Work Item Status

Date Initiated: 02-21-2024

Technical Contact: Lucas Chavez-Pardini

Item: 000

Ballot:

Status: