ASTM F2477-23

Standard Test Methods for <emph type="ital"> in vitro</emph> Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses

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 or endoprosthesis by exposing it to diametric deformation by means of hydrodynamic pulsatile loading. This testing occurs on a test sample that has been deployed into a mock (elastically simulated) vessel. The test is conducted for a number of cycles to adequately establish the intended fatigue resistance of the sample.  
1.2 These test methods are applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys and endovascular prostheses with metal stents. This standard 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 may be used for assessing stent and endovascular prosthesis durability when exposed to blood vessel cyclic diametric change. These test methods do not address other cyclic loading modes such as bending, torsion, extension, or compression.  
1.4 These test methods are primarily intended for use with physiologically relevant diametric change, however guidance is provided for hyper-physiologic diametric deformation (that is, fatigue to fracture).  
1.5 These test methods do address test conditions for curved mock vessels, however might not address all concerns.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 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.  
1.8 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

• Status: Published
• Publication Date: 31-Jan-2023
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.30 - Cardiovascular Standards

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: F2477 − 23
Standard Test Methods for
in vitro Pulsatile Durability Testing of Vascular Stents and
1
Endovascular Prostheses
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 1.8 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 These test methods cover the determination of the
ization established in the Decision on Principles for the
durability of a vascular stent or endoprosthesis by exposing it
Development of International Standards, Guides and Recom-
to diametric deformation by means of hydrodynamic pulsatile
mendations issued by the World Trade Organization Technical
loading. This testing occurs on a test sample that has been
Barriers to Trade (TBT) Committee.
deployed into a mock (elastically simulated) vessel. The test is
conducted for a number of cycles to adequately establish the
2. Referenced Documents
intended fatigue resistance of the sample.
2
2.1 ASTM Standards:
1.2 These test methods are applicable to balloon-expandable
D1193 Specification for Reagent Water
and self-expanding stents fabricated from metals and metal
F2514 Guide for Finite Element Analysis (FEA) of Metallic
alloys and endovascular prostheses with metal stents. This
Vascular Stents Subjected to Uniform Radial Loading
standard does not specifically address any attributes unique to
F3067 Guide for Radial Loading of Balloon-Expandable and
coated stents, polymeric stents, or biodegradable stents, al-
Self-Expanding Vascular Stents
though the application of this test method to those products is
F3172 Guide for Design Verification Device Size and
not precluded.
Sample Size Selection for Endovascular Devices
1.3 These test methods may be used for assessing stent and
F3211 Guide for Fatigue-to-Fracture (FtF) Methodology for
endovascular prosthesis durability when exposed to blood
Cardiovascular Medical Devices
vessel cyclic diametric change. These test methods do not 3
2.2 ISO Standards:
address other cyclic loading modes such as bending, torsion,
ISO 7198:2016, A.5.9 Dynamic radial compliance—tubular
extension, or compression.
vascular grafts only
1.4 These test methods are primarily intended for use with ISO 14971 Medical Devices—Application of Risk Manage-
physiologically relevant diametric change, however guidance ment to Medical Devices
is provided for hyper-physiologic diametric deformation (that
3. Terminology
is, fatigue to fracture).
3.1 Definitions of Terms Specific to This Standard:
1.5 These test methods do address test conditions for curved
3.1.1 cardiac cycle, n—defined as one cycle from diastolic
mock vessels, however might not address all concerns.
pressure to systolic pressure and back to diastolic pressure.
1.6 The values stated in SI units are to be regarded as
3.1.2 compliance, n—the change in inner diameter of a
standard. No other units of measurement are included in this
vessel due to cyclic pressure changes. Compliance, if
standard.
calculated, shall be expressed as a percentage of the diameter
1.7 This standard does not purport to address all of the
change per 100 mmHg and defined per ISO 7198, A.5.9, or
safety concerns, if any, associated with its use. It is the
equivalently:
responsibility of the user of this standard to establish appro-
4
Dp2 2 Dp1 × 10
~ !
priate safety, health, and environmental practices and deter-
%Compliance/100 mm Hg 5 (1)
~Dp1~p2 2 p1!!
mine the applicability of regulatory limitations prior to use.
1 2
These test methods are under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and are the direct responsibility of contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Subcommittee F04.30 on Cardiovascular Standards. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Feb. 1, 2023. Published February 2023. Originally the ASTM website.
3
approved in 2006. Last previous edition approved in 2019 as F2477 – 19. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2477-23. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 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 − 19 F2477 − 23
Standard Test Methods for
in vitro Pulsatile Durability Testing of Vascular Stents and
1
Endovascular Prostheses
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 or endoprosthesis by exposing it to
physiologically relevant diametric distension levels diametric deformation by means of hydrodynamic pulsatile loading. This
testing occurs on a stent test specimensample 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.test is conducted for a
number of cycles to adequately establish the intended fatigue resistance of the sample.
1.2 These test methods are applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys.
It alloys and endovascular prostheses with metal stents. This standard 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.
1.3 These test methods are valid for determining stent failure due to typical cyclic blood vessel diametric distension.may be used
for assessing stent and endovascular prosthesis durability when exposed to blood vessel cyclic diametric change. These test
methods do not address other modes of failurecyclic loading modes such as dynamic bending, torsion, extension, crushing, or
abrasion.compression.
1.4 These test methods do not address test conditions for curved mock vessels.are primarily intended for use with physiologically
relevant diametric change, however guidance is provided for hyper-physiologic diametric deformation (that is, fatigue to fracture).
1.5 These test methods do not address test conditions for overlapping stents.curved mock vessels, however might not address all
concerns.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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
These test methods are under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and isare the direct responsibility of Subcommittee
F04.30 on Cardiovascular Standards.
Current edition approved June 1, 2019Feb. 1, 2023. Published July 2019February 2023. Originally approved in 2006. Last previous edition approved in 20132019 as
F2477 – 07F2477 – 19.(2013). DOI: 10.1520/F2477-19.10.1520/F2477-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2477 − 23
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.
1.8 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) Committe
...