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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 047 Date of Entry 08/21/2017 
FR Recognition Number 3-149
Standard
ISO  25539-1 Second edition 2017-02
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
Scope/Abstract
ISO 25539-1:2017 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can 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
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 Coronary Covered Stent HDE NIV
Relevant FDA Guidance and/or Supportive Publications*
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
 Julie Mackel
  CDRH/OPEQ/OHTII/DHTIIC/
  301-796-2879
  Julie.Mackel@fda.hhs.gov
 Nathan Weidenhamer
  CDRH/OPEQ/OHTII/DHTIIB/
  240-402-3577
  Nathan.Weidenhamer@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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