| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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058
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Date of Entry 05/30/2022
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FR Recognition Number
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3-181
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| Standard | |
ISO 25539-2 Third edition 2020-09
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
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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. ... |
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| Extent of Recognition
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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. |
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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| FDA recognition of ISO 25539-2 Second edition 2012-12 [Rec# 3-116] will be superseded by recognition of ISO 25539-2 Third edition 2020-09 [Rec# 3-181].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. |
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Public Law, CFR Citation(s) and Procode(s)*
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| 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 |
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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. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
