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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 058 Date of Entry 05/30/2022 
FR Recognition Number 3-181
Standard
ISO 25539-2 Third edition 2020-09
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
Scope/Abstract
This document specifies requirements for the evaluation of stent systems (vascular stents 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 Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. ...
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FDA recognition of ISO 25539-2 Second edition 2012-12 [Rec# 3-116] will be superseded by recognition of ISO 25539-2 Third edition 2020-09 [Rec# 3-181]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-116] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 3-116] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
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
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.

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

Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems: Guidance for Industry and Food and Drug Administration Staff, issued August 2015.

ASTM F2514-21 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading.

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
 Julie Mackel
  CDRH/OPEQ/OHTII/DHTIIC
  301-796-2879
  Julie.Mackel@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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