ASTM F2942-19
(Guide)Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
Standard Guide for <emph type="bdit">in vitro</emph> Axial, Bending, and Torsional Durability Testing of Vascular Stents
SIGNIFICANCE AND USE
5.1 It is important to consider the durability of stent designs in deformation modes that are intended to model in vivo conditions. The appropriate amplitude and number of cycles in each of the modes have to be determined independently for the particular clinical use proposed for the stent. These tests do not replicate all varieties and aspects of the deployment process nor the in vivo mechanical environment in its entirety, and as such they cannot be proofs of durability. Instead, the tests provide evidence of durability. The durability tests can also provide a means of assessing design, material or processing changes.
5.1.1 This guide might be useful for development testing, specification acceptance testing, and regulatory submission testing and filings as it provides a basic assurance that the tests are designed, executed, and reported in a suitable fashion.
5.1.2 If the tests are conducted using a well defined FTF methodology, they can be useful in:
5.1.2.1 Potential design improvement through identification of better and worse geometries, materials, and manufacturing processes;
5.1.2.2 Understanding product durability by estimating the effects of changes in geometry, materials, or manufacturing processes;
5.1.2.3 Estimating the safety factor relative to the amplitudes and other factors in use conditions; and
5.1.2.4 Validating finite element analysis (FEA) and fatigue life models.
5.1.3 As stated in the scope, this guide is not intended to provide the in vivo physiologic deformation conditions to which a vascular stent can be subjected. Reliable clinical data characterizing cyclic vascular deformation may be lacking for some indications. The user should develop and justify the boundary conditions (e.g., by literature review, in vivo studies, cadaver studies, or modeling of stent vessel interaction) for the chosen durability bench tests. Additional conditions that may be considered include vessel calcification, vessel taper, eccentric lesions, d...
SCOPE
1.1 This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional.
1.2 This guide does not address flat plate, local crush durability, or multi-mode testing. Although this guide does not address multi-mode testing, the information included herein could be applicable to developing this type of test.
1.3 This guide applies to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents (i.e., stents with a surface layer of an additional material(s)), monolithically polymeric stents, or absorbable stents, although the application of this standard to those products is not precluded.
1.4 This guide applies to endovascular grafts (“stent-grafts”) and other conduit products commonly used to treat aneurismal disease, peripheral vessel trauma, or to provide vascular access. The information provided herein does not address all issues related to testing of these devices.
1.5 This guide is applicable to testing of stent(s) (or a representative portion of a stent). While durability testing of coupon samples (e.g., a scaled-up portion of the stent structure) can provide useful information, it is not within the scope of this guide.
1.6 This guide applies to in vitro modeling of stent durability from non-radial arterial motions. Such motions may arise from musculoskeletal activities, including walking and breathing, and cardiac motion. Test Methods F2477 addresses pulsatile (i.e., radial) durability of vascular stents.
1.7 This guide does not provide the in vivo physiologic deformation conditions for a vascular stent. 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 stent vessel interaction) in these durability bench tests. Additional ...
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2942 − 19
Standard Guide for
in vitro Axial, Bending, and Torsional Durability Testing of
1
Vascular Stents
This standard is issued under the fixed designation F2942; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope cadaver studies, or modeling of stent vessel interaction) in
these durability bench tests.Additional conditions that may be
1.1 This guide includes three separate cyclic deformation
considered include vessel calcification, vessel taper, eccentric
durability guides related to vascular stents: bending, axial, and
lesions, loading excursions (e.g., exercise), and vessel remod-
torsional.
eling.
1.2 This guide does not address flat plate, local crush
1.8 This standard does not purport to address all of the
durability, or multi-mode testing.Although this guide does not
safety concerns, if any, associated with its use. It is the
address multi-mode testing, the information included herein
responsibility of the user of this standard to establish appro-
could be applicable to developing this type of test.
priate safety, health, and environmental practices and deter-
1.3 This guide applies to balloon-expandable and self-
mine the applicability of regulatory limitations prior to use.
expanding stents fabricated from metals and metal alloys. It
1.9 This international standard was developed in accor-
does not specifically address any attributes unique to coated
dance with internationally recognized principles on standard-
stents (i.e., stents with a surface layer of an additional
ization established in the Decision on Principles for the
material(s)), monolithically polymeric stents, or absorbable
Development of International Standards, Guides and Recom-
stents, although the application of this standard to those
mendations issued by the World Trade Organization Technical
products is not precluded.
Barriers to Trade (TBT) Committee.
1.4 This guide applies to endovascular grafts (“stent-
2. Referenced Documents
grafts”) and other conduit products commonly used to treat
2
aneurismal disease, peripheral vessel trauma, or to provide
2.1 ASTM Standards:
vascular access. The information provided herein does not
F2477 Test Methods for in vitro Pulsatile Durability Testing
address all issues related to testing of these devices.
of Vascular Stents
F3211 Guide for Fatigue-to-Fracture (FtF) Methodology for
1.5 This guide is applicable to testing of stent(s) (or a
Cardiovascular Medical Devices
representative portion of a stent). While durability testing of
couponsamples(e.g.,ascaled-upportionofthestentstructure)
2.2 Other Documents:
canprovideusefulinformation,itisnotwithinthescopeofthis ASTM STP 588 Manual on Statistical Planning and
guide.
Analysis, R.E. Little, 1975
1.6 This guide applies to in vitro modeling of stent durabil-
3. Terminology
ity from non-radial arterial motions. Such motions may arise
3.1 Definitions of Terms Specific to This Standard:
from musculoskeletal activities, including walking and
breathing, and cardiac motion. Test Methods F2477 addresses 3.1.1 axial, adj—compression or tension of a stent and/or
mock vessel along its longitudinal axis.
pulsatile (i.e., radial) durability of vascular stents.
3.1.2 bending, adj—deformation on the longitudinal axis of
1.7 This guide does not provide the in vivo physiologic
a stent and/or mock vessel to achieve a specified stent radius of
deformation conditions for a vascular stent. It is incumbent
curvature.
upon the user of the standard to develop and justify these
boundary conditions (e.g., by literature review, in vivo studies,
3.1.3 fracture, n—complete separation of a stent element or
component (e.g., strut, apex, bridge, marker).
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.30 on Cardiovascular Standards. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
CurrenteditionapprovedJune1,2019.PublishedJuly2019.Originallyapproved contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
in2013.Lastpreviouseditionapprovedin2013asF2942–13.DOI:10.1520/F2942- Standards volume information, refer to the standard’s Document Summary page on
19. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2942 − 13 F2942 − 19
Standard Guide for
in vitro Axial, Bending, and Torsional Durability Testing of
1
Vascular Stents
This standard is issued under the fixed designation F2942; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and
torsional.
1.2 This guide does not address flat plate, local crush durability, or multi-mode testing. Although this guide does not address
multi-mode testing, the information included herein could be applicable to developing this type of test.
1.3 This guide applies to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not
specifically address any attributes unique to coated stents (i.e., stentstents with a surface layer of an additional material(s)),
monolithically polymeric stents, or absorbable stents, although the application of this standard to those products is not precluded.
1.4 This guide applies to endovascular grafts (“stent-grafts”) and other conduit products commonly used to treat aneurismal
disease, peripheral vessel trauma, or to provide vascular access. The information provided herein does not address all issues related
to testing of these devices.
1.5 This guide is applicable to testing of stent(s) (or a representative portion of a stent). While durability testing of coupon
samples (e.g., a scaled-up portion of the stent structure) can provide useful information, it is not within the scope of this guide.
1.5 This guide applies to endovascular grafts (“stent-grafts”) and other conduit products commonly used to treat aneurismal
disease, peripheral vessel trauma, or to provide vascular access. The information provided herein does not address all issues related
to testing of these devices.
1.6 This guide applies to in vitro modeling of stent durability from non-radial arterial motions. Such motions may arise from
musculoskeletal activities, including walking and breathing, and cardiac motion. ASTM Test Methods F2477 addresses pulsatile
(i.e., radial) durability of vascular stents.
1.7 This guide does not provide the in vivo physiologic deformation conditions for a vascular stent. 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 stent vessel 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.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
F2477 Test Methods forin vitro Pulsatile Durability Testing of Vascular Stents
F3211 Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
1
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.30 on Cardiovascular Standards.
Current edition approved Aug. 15, 2013June 1, 2019. Published September 2013July 2019. Originally approved in 2013. Last previous edition approved in 2013 as
F2942–13. DOI: 10.1520/F2942-13.10.1520/F2942-19.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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