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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 08/06/2013 
FR Recognition Number 3-87
Standard
ASTM  F2477-07 (Reapproved 2013)
Standard Test Methods for in vitro Pulsatile Durability
Scope/Abstract
These test methods cover the determination of the durability of a vascular stent by exposing it to physiologically relevant diametric distension levels by means of hydrodynamic pulsatile loading. This testing occurs on a stent test specimen that has been deployed into a mock (elastically simulated) vessel. The typical duration of this test is 10 years of equivalent use (at 72 beats per minute), or at least 380 million cycles.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ASTM F2477-07 (Reapproved 2013) [Rec# 3-87] will be superseded by recognition of ASTM F2477-23 [Rec# 3-184]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-87] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 3-87] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
N/A Stent, Coronary Class 3 MAF
N/A Stent, Carotid Class 3 NIM
N/A Stent, Renal Class 3 NIN
N/A Stent, Iliac Class 3 NIO
N/A Stent, Superficial Femoral Artery Class 3 NIP
N/A Coronary Drug-Eluting Stent Class 3 NIQ
N/A Intracranial Neurovascular Stent HDE NJE
N/A Intracranial Aneurysm Flow Diverter Class 3 OUT
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Finn Donaldson
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  301-796-9579
  Finn.Donaldson@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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