ASTM F2942-13

Standard Guide For The In Vitro Axial, Bending, And Rotational Durability Test Of Vascular Stents

F2942-13

Standard Organization: ASTM

ASTM F2942-13
Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents

• Recognition Number: Cardiovascular
• Recognition Date: 2019-01-14
• Recognition List: 051
• Recognition Number: 3-138
• Extent: Complete standard
• Standards Orgs: ASTM ASTM International http://www.astm.org/
• STG: Cardiovascular
• FDA Tech: Finn Donaldson FDA/OMPT/CDRH/ODE/DCD/PIDB/ 301-796-9579 Finn.Donaldson@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional.This guide does not address flat plate, local crush durability, or multi-mode testing.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Coronary Drug-Eluting Stent	Class 3	NIQ
Unclassified	Stent, Carotid	Class 3	NIM
Unclassified	Stent, Coronary	Class 3	MAF
Unclassified	Stent, Iliac	Class 3	NIO
Unclassified	Stent, Renal	Class 3	NIN
Unclassified	Stent, Superficial Femoral Artery	Class 3	NIP
Unclassified	System, Endovascular Graft, Aortic Aneurysm Treatment	Class 3	MIH
Unclassified	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Class 3	PFV

FDA Guidance:

Guidance for Industry Coronary Drug-Eluting Stents¿ Nonclinical and Clinical Studies, Issued March 2008.

Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.