ASTM F3036-21
(Guide)Standard Guide for Testing Absorbable Stents
Standard Guide for Testing Absorbable Stents
SIGNIFICANCE AND USE
4.1 Absorbable cardiovascular stents provide temporary support to the vasculature and are intended to degrade and absorb over time after being implanted into the vasculature.
4.2 The test methods used to evaluate the mechanical performance of absorbable devices are similar to those used to evaluate permanent (non-absorbable) cardiovascular devices. The absorbable-specific pre-test conditioning requirements, handling requirements before and during the test, and time-dependent mechanical property evaluations for absorbable devices are addressed here.
4.3 As the absorbable implant degrades, the mechanical performance of the device also deteriorates. The key to achieving effective revascularization with absorbable devices is to provide an adequate level of luminal support for the time frame needed for vessel stabilization.
SCOPE
1.1 This guide covers select physical and mechanical characterizations of vascular stents with one or more absorbable components. Such absorbable stents (also referred to as vascular scaffolds) are used to provide temporary luminal support of the coronary and peripheral vasculature following interventional revascularization procedures. This guide covers devices that are fabricated from one or more degradable polymers and/or metals (from this point on referred to as “absorbable”). This guide provides a framework for evaluating the change in select physical and mechanical characteristics of absorbable stents from manufacture through their intended degradation in vivo. Specific testing recommendations are limited to existing ASTM standards for stent evaluation.
1.2 Recommendations specific to non-absorbable stents with absorbable coatings are not within scope.
1.3 Recommendations specific to testing absorbable stent grafts are not provided here; however, this standard has many elements applicable to testing absorbable stent grafts.
1.4 Clinical need dictates that absorbable stents initially possess the same general dimensions and mechanical function as their non-absorbable counterparts. Thus, utilization of already established mechanical stent evaluation methods is possible when absorbable test specimens are previously conditioned under physiologically relevant temperature and humidity. As a result, this standard addresses absorbable-specific testing issues related to the mechanical and physical evaluation of these devices. The annexes in this standard provide absorbable-specific testing recommendations for evaluations where an ASTM test method for durable (that is, non-absorbable) stents is already available. Specifically, this standard provides testing recommendations for adapting the elastic recoil (F2079), dimensional attributes (F2081), securement/dislodgement (F2394), pulsatile durability (F2477), FEA of stents (F2514), three-point bending (F2606), coating/acute particulate characterization (F2743), shelf life (F2914), axial bend torsional rigidity (F2942), radial loading (F3067), design verification sampling (F3172), fatigue to fracture (F3211), and fixation durability (F3374) tests to fully absorbable devices. This guide generally describes specimen conditioning, as appropriate, for absorbable devices, which can range from none to extensive depending on the measured attribute and relevant clinical exposure conditions, including time in the in-use environment. Additional stent evaluation methods that are not addressed explicitly in this guide may require absorbable-specific provisions. The user should justify the appropriate testing for the specific absorbable material and device.
1.4.1 While the primary purpose of this guide is to address absorbable stent-related issues specific to the tests described in 1.4, additional testing (for example, radial strength) will likely also be needed. Thus, aspects of what is presented herein may be applicable to additional relevant device attributes, such as those described in ISO 25539-1 and/or 25539-2.
1.5 T...
General Information
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Standards Content (Sample)
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: F3036 − 21
Standard Guide for
1
Testing Absorbable Stents
This standard is issued under the fixed designation F3036; 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 bend torsional rigidity (F2942), radial loading (F3067), design
verification sampling (F3172), fatigue to fracture (F3211), and
1.1 This guide covers select physical and mechanical char-
fixation durability (F3374) tests to fully absorbable devices.
acterizations of vascular stents with one or more absorbable
This guide generally describes specimen conditioning, as
components. Such absorbable stents (also referred to as vas-
appropriate, for absorbable devices, which can range from
cular scaffolds) are used to provide temporary luminal support
none to extensive depending on the measured attribute and
of the coronary and peripheral vasculature following interven-
relevant clinical exposure conditions, including time in the
tional revascularization procedures. This guide covers devices
in-use environment. Additional stent evaluation methods that
that are fabricated from one or more degradable polymers
are not addressed explicitly in this guide may require
and/or metals (from this point on referred to as “absorbable”).
absorbable-specific provisions. The user should justify the
This guide provides a framework for evaluating the change in
appropriate testing for the specific absorbable material and
select physical and mechanical characteristics of absorbable
device.
stents from manufacture through their intended degradation in
1.4.1 While the primary purpose of this guide is to address
vivo. Specific testing recommendations are limited to existing
absorbable stent-related issues specific to the tests described in
ASTM standards for stent evaluation.
1.4, additional testing (for example, radial strength) will likely
1.2 Recommendations specific to non-absorbable stents
also be needed. Thus, aspects of what is presented herein may
with absorbable coatings are not within scope.
be applicable to additional relevant device attributes, such as
1.3 Recommendations specific to testing absorbable stent
those described in ISO 25539-1 and/or 25539-2.
grafts are not provided here; however, this standard has many
1.5 This guide may not be appropriate for all absorbable
elements applicable to testing absorbable stent grafts.
devices, for example those that possess limited hydrolytic or
1.4 Clinical need dictates that absorbable stents initially
corrosion susceptibility and degrade in vivo primarily through
possess the same general dimensions and mechanical function
enzymatic action. The user is cautioned to consider the
as their non-absorbable counterparts. Thus, utilization of al-
appropriateness of the standard in view of the particular
ready established mechanical stent evaluation methods is
absorbable device and its potential application.
possible when absorbable test specimens are previously con-
1.6 This guide does not address the methods necessary to
ditioned under physiologically relevant temperature and hu-
characterize the chemical degradation of the absorbable stent
midity.As a result, this standard addresses absorbable-specific
(for example, changes in mass, molecular weight, or degrad-
testingissuesrelatedtothemechanicalandphysicalevaluation
ants). However, this type of characterization does represent an
of these devices. The annexes in this standard provide
important component of the degradation profile and mecha-
absorbable-specific testing recommendations for evaluations
nism of the device. These characterizations are addressed in
where an ASTM test method for durable (that is, non-
Test Method F1635, ISO 13781, or Guide F3268, as appropri-
absorbable) stents is already available. Specifically, this stan-
ate.
dard provides testing recommendations for adapting the elastic
recoil (F2079), dimensional attributes (F2081), securement/
1.7 The provided supplemental information is to be consid-
dislodgement (F2394), pulsatile durability (F2477), FEA of
eredasspecifictoabsorbableconstructsandappliesonlytothe
stents (F2514), three-point bending (F2606), coating/acute
respective referenced cardiovascular-oriented ASTM docu-
particulate characterization (F2743), shelf life (F2914), axial
ments.
1.8 Additional (especially non-mechanical) device attri-
1
butes that are not addressed in this document or through the
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
...
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: F3036 − 13 F3036 − 21
Standard Guide for
1
Testing Absorbable Stents
This standard is issued under the fixed designation F3036; 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 Guideguide covers select physical and mechanical characterizations of vascular stents with one or more absorbable
components. Such absorbable stents (also referred to as vascular scaffolds) are used to provide temporary luminal support of the
coronary and peripheral vasculature following interventional revascularization procedures. This Guideguide covers devices that are
fabricated from one or more degradable polymers and/or metals (from this point on referred to as “absorbable”). This Guideguide
provides a framework for evaluating the change in select physical and mechanical characteristics of absorbable stents from
manufacture through their intended degradation in vivo. Specific testing recommendations are limited to existing ASTM standards
for stent evaluation.
1.2 Recommendations specific to non-absorbable stents with absorbable coatings are not within scope.
1.3 Recommendations specific to testing absorbable stent grafts are not provided here, howeverhere; however, this standard has
many elements applicable to testing absorbable stent grafts.
1.4 Clinical need dictates that absorbable stents initially possess the same general dimensions and mechanical function as their
non-absorbable counterparts. Thus, utilization of already established mechanical stent evaluation methods is possible when
absorbable test specimens are previously conditioned under physiologically relevant temperature and humidity. As a result, this
standard addresses absorbable-specific testing issues related to the mechanical and physical evaluation of these devices. This
standard is limited to providingThe annexes in this standard provide absorbable-specific testing recommendations for evaluations
where an ASTM test method for durable (i.e., (that is, non-absorbable) stents is already available. Specifically, this standard
provides testing recommendations for adapting the elastic recoil (ASTM (F2079), dimensional attributes (F2081), securement/
dislodgement (ASTM (F2394), and pulsatile durability (F2477), FEA of stents (F2514), three-point bending (ASTM(F2606),
coating/acute particulate characterization (F2606F2743), shelf life (F2914), axial bend torsional rigidity (F2942), radial loading
(F3067), design verification sampling (F3172), fatigue to fracture (F3211), and fixation durability (F3374) tests to fully absorbable
devices. This guide generally describes specimen conditioning, as appropriate, for absorbable devices, which can range from none
to extensive – depending on the measured attribute and relevant clinical exposure conditions, including time in the in-use
environment. There are additional Additional stent evaluation methods that are not addressed explicitly in this guide, e.g., chronic
durability, that guide may require absorbable-specific provisions. The user should justify the appropriate testing for the specific
polymer absorbable material and device.
1.4.1 While the primary purpose of this guide is to address absorbable stent-related issues specific to the tests described in Section
1.31.4, additional testing (e.g., (for example, radial strength) will likely also be needed. Thus, aspects of what is presented herein
may be applicable to additional relevant device attributes, such as those described in ISO 25539-1 and/or 25539-2.
1
This test method guide 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 Nov. 1, 2013Nov. 1, 2021. Published December 2013November 2021. Originally approved in 2013. Last previous edition approved in 2013 as
F3036 – 13. DOI: 10.1520/F3036-13.10.1520/F3036-21.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F3036 − 21
1.5 This Guideguide may not be appropriate for all absorbable devices, for example those that possess limited hydrolytic or
corrosion susceptibility and degrade in vivo primarily through enzymatic action. The user is cautioned
...
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