ASTM F2942-13
Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

Standard No.

ASTM F2942-13

Release Date

2013

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2942-19

Latest

ASTM F2942-19

Scope

5.1 It is important to consider the durability of stent designs in deformation modes that are intended to model in vivo conditions. The appropriate amplitude and number of cycles in each of the modes has to be determined independently for the particular clinical use proposed for the stent. These tests do not replicate all varieties and aspects of the deployment process and the in vivo mechanical environment so they cannot be proofs of durability. Instead, the tests provide evidence of durability. The durability tests can also provide a means of assessing design, material or processing changes.

5.1.1 This guide might be useful for development testing, specification acceptance testing, and regulatory submission testing and filings as it provides a basic assurance that the tests are designed, executed, and reported in a suitable fashion.

5.1.2 If the tests are conducted using a well-defined FTF methodology, they can be useful in:

5.1.2.1 Potential design improvement through identification of better and worse geometries, materials, and manufacturing processes;

5.1.2.2 Understanding product durability by estimating the effects of changes in geometry, materials, or manufacturing processes;

5.1.2.3 Estimating the safety factor relative to the amplitudes and other factors in use conditions; and

5.1.2.4 Validating finite element analysis (FEA) and fatigue life models.

5.1.3 As stated in the scope, this guide is not intended to provide the in vivo physiologic deformation conditions that a vascular stent can be subjected. Reliable clinical data characterizing cyclic vascular deformation may be lacking for some indications. The user should develop and justify the boundary conditions (e.g., literature review, in vivo studies, cadaver studies, or modeling of stent vessel interaction) for the chosen durability bench tests. Additional conditions that may be considered include vessel calcification, vessel taper, eccentric lesions, deformation excursions (e.g., exercise), and vessel remodeling.

5.1.4 Test methods other than those provided in the annexes of this document might be appropriate, depending upon stent design. However, these methods are beyond the scope of this guide.

1.1 This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional.

1.2 This guide does not address flat plate, local crush durability, or multi-mode testing.

1.3 This guide applies to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents (i.e., stent with a surface layer of an additional material(s)), monolithically polymeric stents, or absorbable stents, although the application of this standard to those products is not precluded.

1.4 This guide is applicable to testing of stent(s) (or a representative portion of a stent). While durability testing of coupon samples (e.g., a scaled-u......

ASTM F2942-13 Referenced Document

• ASTM F2477 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
• ISO 25539 Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices

ASTM F2942-13 history

• 2019 ASTM F2942-19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
• 2013 ASTM F2942-13 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents