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U.S. Department of Health and Human Services

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
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FDA recognition of ISO 25539-2 Second edition 2012-12 [Rec# 3-116] will be superseded by recognition of ISO 25539-2 Third edition 2020-09 [Rec# 3-181].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.
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.

ASTM F2514-08 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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