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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 057 Date of Entry 12/20/2021 
FR Recognition Number 3-180
Standard
ASTM  F3505-21
Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
Scope/Abstract
1.1 This standard addresses the kink resistance of stents and endovascular prostheses (for example, stent grafts). The standard may also be applicable to scaffolds.

1.2 Test methods presented herein address the kink resistance of stents and endovascular protheses when exposed to bending in a single plane. While concurrent influences (for example, torque) are recognized to influence kinking properties, test methods other than single-plane bending are not addressed.

1.3 Test methods presented herein do not specifically address kink resistance of branched (for example, bifurcated) or multicomponent endovascular prostheses, but some aspects of this standard may be applicable to their application.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
N/A System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH
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 Stent, Superficial Femoral Artery, Drug-Eluting Class 3 NIU
N/A System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Class 3 PFV
N/A Iliac Covered Stent, Arterial Class 3 PRL
N/A Stent, Iliac Vein Class 3 QAN
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 Contacts
 Rohini Retarekar
  CDRH/OPEQ/OHTII
  240-402-3750
  rohini.retarekar@fda.hhs.gov
 Gordon Bryson
  CDRH/OPEQ/OHTII
  301-837-7566
  gordon.bryson@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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