ASTM F3374-19
Standard Guide for Active Fixation Durability of Endovascular Prostheses

Standard No.

ASTM F3374-19

Release Date

2019

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F3374-19

Scope

1.1 This guide addresses how to conduct in vitro durability testing on active fixation components (AFCs) and attachment mechanisms of endovascular prostheses. It does not address the durability of fixation systems that reside solely within the vessel lumen to resist device migration (e.g, radial force and friction, adhesives, or geometric fit). 1.2 This guide was developed to address active fixation durability for aortic stent grafts. It is not intended to address fixation durability for other endovascular prostheses such as inferior vena cava filters, transcatheter heart valves, barbed venous stents, ancillary fixation devices (e.g, staples or adhesives), or cardiac devices (e.g., left atrial appendage device or mitral repair device). However, some of the techniques and guidance within may be applicable to the in vitro testing of those other devices. 1.3 This guide does not directly apply to implants with absorbable AFCs although many aspects of this standard are applicable to those products. 1.4 This guide does not provide the in vivo physiologic loading conditions for endovascular prostheses. It is the responsibility of the user to determine the loading or deformation conditions for their particular device and indication. Typically, an axial loading (force or displacement) mode caused by hemodynamics is used, although other modes are possible and should be considered. 1.5 This guide does not recommend any specific test method or apparatus for evaluating active fixation durability. It is recognized that there are multiple valid ways to conduct active fixation durability testing and as such this guide provides general recommendations and topics to consider so that users can successfully develop a test plan for their device. 1.6 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F3374-19 Referenced Document

• ASTM E739 Standard Practice for Statistical Analysis of Linear or Linearized Stress-Life (S-N) and Strain-Life (949;-N) Fatigue Data
• ASTM F2477 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses*， 2023-02-01 Update
• ASTM F2942 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
• ASTM F3172 Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices*， 2021-08-01 Update
• ASTM F3211 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
• ISO 25539 Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices*， 2021-11-12 Update

ASTM F3374-19 history

• 2019 ASTM F3374-19 Standard Guide for Active Fixation Durability of Endovascular Prostheses