| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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066
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Date of Entry 05/25/2026
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FR Recognition Number
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3-207
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| Standard | |
ASTM F2942-25
Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents |
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Scope/Abstract1.1 This guide includes four separate cyclic deformation durability guides related to vascular stents and vascular stent-grafts: bending, axial, torsional, and compression.
1.2 This guide does not address whether a specific mode of durability testing is relevant for a particular vascular stent and vascular stent-graft design.
1.3 This guide does not address multi-mode testing. Nevertheless, the information included herein could be applicable to developing this type of test.
1.4 This guide applies to vascular stents and vascular stent-grafts, including balloon-expandable and self-expanding stents fabricated from metals and metal alloys commonly used to treat aneurysmal disease, peripheral vessel trauma, or to provide vascular access. These are referred to as the 'implant' throughout the subsequent text. The information provided herein does not address all issues related to testing of these devices.
1.5 This guide does not apply to structural heart implants including but not limited to: aortic valve replacement, mitral and tricuspid valve replacement and repair devices, annuloplasty rings, intra-atrial shunts, pacemaker leads, LVADs, etc.
1.6 This guide does not specifically address any attributes unique to coated implants (i.e., implants with a surface layer of an additional material(s)), monolithically polymeric implants, or absorbable implants, although the application of this standard to such products is not precluded.
1.7 This guide is applicable to testing of stents and stent-grafts (or a representative portion of a stent). While the scope of this document does not explicitly cover coupon or surrogate samples, the information in this guide can provide useful information for them.
1.8 This guide applies to in vitro testing of implant durability from non-radial motions. Such motions may arise from musculoskeletal activities, including walking, stair climbing, leg crossing, kneeling, breathing, valsalva, and cardiac motion, as well as extrinsic forces on the body such as lifting of patients between beds.
1.9 This guide does not provide the in vivo physiologic deformation conditions for testing. It is incumbent upon the user of the standard to develop and justify these boundary conditions (e.g., by literature review, in vivo studies, cadaver studies, or modeling of implant in vivo interaction) in these durability bench tests. Additional conditions that may be considered include vessel calcification, vessel taper, eccentric lesions, loading excursions (e.g., exercise), and vessel remodeling.
1.10 This guide does not result in quantitative estimates of implant durability, but rather provides qualitative results (i.e., pass or fail). |
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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 ASTM F2942-19 [Rec# 3-189] will be superseded by recognition of ASTM F2942-25 [Rec# 3-207]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-189] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 3-189] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| N/A |
Stent, Superficial Femoral Artery, Drug-Eluting
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Class 3
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NIU
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| N/A |
Iliac Covered Stent, Arterial
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Class 3
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PRL
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| N/A |
Stent, Iliac Vein
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Class 3
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QAN
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| N/A |
Stent Graft, Bypass, Superficial Femoral Artery
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Class 3
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QWM
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| N/A |
Stent, Coronary |
Class 3
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MAF
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| N/A |
System, Endovascular Graft, Aortic Aneurysm Treatment |
Class 3
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MIH
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| N/A |
Stent, Carotid |
Class 3
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NIM
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| N/A |
Stent, Renal |
Class 3
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NIN
|
| N/A |
Stent, Iliac |
Class 3
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NIO
|
| N/A |
Stent, Superficial Femoral Artery |
Class 3
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NIP
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| N/A |
Coronary Drug-Eluting Stent |
Class 3
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NIQ
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| N/A |
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment |
Class 3
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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.
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. |
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