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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 08/06/2013 
FR Recognition Number 3-116
Standard
ISO 25539-2 Second edition 2012-12-01
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
U.S. Identical Adoption
ANSI AAMI ISO 25539-2:2012
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
Scope/Abstract
This part of ISO 25539 specifies requirements for vascular stents, based upon current medical
knowledge. With regard to safety, it gives requirements for intended performance, design attributes,
materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the
manufacturer. It should be considered as a supplement to ISO 14630, which specifies general
requirements for the performance of non-active surgical implants.
Extent of Recognition
Complete standard
Relevant FDA Guidance and/or Supportive Publications*
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, April 18, 2010

Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices, July 29, 2010

ASTM F2514-08 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
FDA Technical Contact
 Jhumur Banik
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-5239
  Jhumur.Banik@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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