ASTM F2477-19
(Test Method)Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
Standard Test Methods for <emph type="bdit">in vitro</emph> Pulsatile Durability Testing of Vascular Stents
ABSTRACT
This test method covers the procedure for determining the durability of ballon-expandable and self- expanding metal or alloy vascular stents. Tests are performed by exposing specimens to physiologically relevant diametric distention levels using hydrodynamic pulsatile loading. Specimens should have been deployed into a mock or elastically simulated vessel prior to testing. The test methods are valid for determining stent failure due to typical cyclic blood vessel diametric distention and include physiological pressure tests and diameter control tests. These do not address other modes of failure such as dynamic bending, torsion, extension, crushing, or abrasion. Test apparatus include a pressure measurement system, dimensional measurement devices, a cycle counting system, and a temperature control system.
SCOPE
1.1 These test methods cover the determination of the durability of a vascular stent by exposing it to physiologically relevant diametric distension levels by means of hydrodynamic pulsatile loading. This testing occurs on a stent test specimen that has been deployed into a mock (elastically simulated) vessel. The typical duration of this test is 10 years of equivalent use (at 72 beats per minute), or at least 380 million cycles.
1.2 These test methods are applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents, polymeric stents, or biodegradable stents, although the application of this test method to those products is not precluded.
1.3 These test methods do not include recommendations for endovascular grafts (“stent-grafts”) or other conduit products commonly used to treat aneurismal disease or peripheral vessel trauma or to provide vascular access, although some information included herein may be applicable to those devices.
1.4 These test methods are valid for determining stent failure due to typical cyclic blood vessel diametric distension. These test methods do not address other modes of failure such as dynamic bending, torsion, extension, crushing, or abrasion.
1.5 These test methods do not address test conditions for curved mock vessels.
1.6 These test methods do not address test conditions for overlapping stents.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.9 General Caveat—This document contains guidance for testing as is currently carried out in most laboratories. Other testing techniques may prove to be more effective and are encouraged. Whichever technique is used, it is incumbent upon the tester to justify the use of the particular technique, instrument, and protocol. This includes the choice of and proper calibration of all measuring devices. Deviations from any of the suggestions in this document may be appropriate but may require the same level of comprehensive justification that the techniques described herein will require.
1.10 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.
General Information
Buy Standard
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2477 − 19
Standard Test Methods for
1
in vitro Pulsatile Durability Testing of Vascular Stents
This standard is issued under the fixed designation F2477; 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 1.9 General Caveat—This document contains guidance for
testing as is currently carried out in most laboratories. Other
1.1 These test methods cover the determination of the
testing techniques may prove to be more effective and are
durability of a vascular stent by exposing it to physiologically
encouraged. Whichever technique is used, it is incumbent upon
relevant diametric distension levels by means of hydrodynamic
the tester to justify the use of the particular technique,
pulsatile loading. This testing occurs on a stent test specimen
instrument, and protocol. This includes the choice of and
that has been deployed into a mock (elastically simulated)
proper calibration of all measuring devices. Deviations from
vessel. The typical duration of this test is 10 years of equivalent
any of the suggestions in this document may be appropriate but
use (at 72 beats per minute), or at least 380 million cycles.
may require the same level of comprehensive justification that
1.2 These test methods are applicable to balloon-expandable
the techniques described herein will require.
and self-expanding stents fabricated from metals and metal
1.10 This international standard was developed in accor-
alloys. It does not specifically address any attributes unique to
dance with internationally recognized principles on standard-
coated stents, polymeric stents, or biodegradable stents, al-
ization established in the Decision on Principles for the
though the application of this test method to those products is
Development of International Standards, Guides and Recom-
not precluded.
mendations issued by the World Trade Organization Technical
1.3 These test methods do not include recommendations for
Barriers to Trade (TBT) Committee.
endovascular grafts (“stent-grafts”) or other conduit products
commonly used to treat aneurismal disease or peripheral vessel
2. Referenced Documents
trauma or to provide vascular access, although some informa-
tion included herein may be applicable to those devices.
2.1 Other Documents:
ISO 7198: 1998(e), 8.10, Determination of Dynamic Com-
1.4 These test methods are valid for determining stent
2
failure due to typical cyclic blood vessel diametric distension. pliance
These test methods do not address other modes of failure such FDA Guidance Document 1545, Non-Clinical Tests and
as dynamic bending, torsion, extension, crushing, or abrasion. Recommended Labeling for Intravascular Stents and As-
3
sociated Delivery Systems, (issued January 13, 2005)
1.5 These test methods do not address test conditions for
curved mock vessels.
3. Terminology
1.6 These test methods do not address test conditions for
3.1 Definitions of Terms Specific to This Standard:
overlapping stents.
3.1.1 cardiac cycle, n—defined as one cycle between dia-
1.7 The values stated in SI units are to be regarded as
stolic and systolic pressures.
standard. No other units of measurement are included in this
standard. 3.1.2 compliance, n—the change in inner diameter of a
vessel due to cyclic pressure changes. Compliance, if
1.8 This standard does not purport to address all of the
calculated, shall be expressed as a percentage of the diameter
safety concerns, if any, associated with its use. It is the
change per 100 mm Hg and defined per ISO 7198, 8.10.5:
responsibility of the user of this standard to establish appro-
4
priate safety, health, and environmental practices and deter-
Dp2 2 Dp1 × 10
~ !
%Compliance/100 mm Hg5 (1)
mine the applicability of regulatory limitations prior to use.
~Dp1~p2 2 p1!!
1
These test methods are under the jurisdiction of ASTM Committee F04 on
2
Medical and Surgical Materials and Devices and is the direct responsibility of Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
Subcommittee F04.30 on Cardiovascular Standards. 4th Floor, New York, NY 10036, http://www.ansi.org.
3
Current edition approved June 1, 2019. Published July 2019. Originally approved Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
in 2006. Last previous edition approved in 2013 as F2477 – 07(2013). DOI: Rockville, MD 20857, http://www.fda.gov. This document available at http://
10.1520/F2477-19. www.fda.gov/cdrh/ode/guidance/1545.pdf.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------
...
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: F2477 − 07 (Reapproved 2013) F2477 − 19
Standard Test Methods for
1
in vitro Pulsatile Durability Testing of Vascular Stents
This standard is issued under the fixed designation F2477; 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 These test methods cover the determination of the durability of a vascular stent by exposing it to physiologically relevant
diametric distension levels by means of hydrodynamic pulsatile loading. This testing occurs on a stent test specimen that has been
deployed into a mock (elastically simulated) vessel. The typical duration of this test is 10 years of equivalent use (at 72 beats per
minute), or at least 380 million cycles.
1.2 These test methods are applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys.
It does not specifically address any attributes unique to coated stents, polymeric stents, or biodegradable stents, although the
application of this test method to those products is not precluded.
1.3 These test methods do not include recommendations for endovascular grafts (“stent-grafts”) or other conduit products
commonly used to treat aneurismal disease or peripheral vessel trauma or to provide vascular access, although some information
included herein may be applicable to those devices.
1.4 These test methods are valid for determining stent failure due to typical cyclic blood vessel diametric distension. These test
methods do not address other modes of failure such as dynamic bending, torsion, extension, crushing, or abrasion.
1.5 These test methods do not address test conditions for curved mock vessels.
1.6 These test methods do not address test conditions for overlapping stents.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 General Caveat—This document contains guidance for testing as is currently carried out in most laboratories. Other testing
techniques may prove to be more effective and are encouraged. Whichever technique is used, it is incumbent upon the tester to
justify the use of the particular technique, instrument, and protocol. This includes the choice of and proper calibration of all
measuring devices. Deviations from any of the suggestions in this document may be appropriate but may require the same level
of comprehensive justification that the techniques described herein will require.
1.10 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
2.1 Other Documents:
2
ISO 7198: 1998(e), 8.10, Determination of Dynamic Compliance
FDA Guidance Document 1545, Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated
3
Delivery Systems, (issued January 13, 2005)
1
These test methods are 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 March 1, 2013June 1, 2019. Published March 2013July 2019. Originally approved in 2006. Last previous edition approved in 20072013 as
F2477 – 07.F2477 – 07(2013). DOI: 10.1520/F2477-07R13.10.1520/F2477-19.
2
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
3
Available from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http://www.fda.gov. This document available at http://www.fda.gov/
cdrh/ode/guidance/1545.pdf.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2477 − 19
3. Terminology
3.1 Definitions of Te
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.