ASTM F3211-17
(Guide)Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
SIGNIFICANCE AND USE
5.1 Use of this Methodology:
5.1.1 This guide provides a compendium of information on methods to use fracture data, fatigue life models, and statistical techniques to estimate the structural fatigue durability of an implantable medical device under anticipated in vivo loading modes. The methodology for high-cycle fatigue assessment relies on hyper-physiological tests intended to cause device fractures. Using the FtF methodology, fractures should not be avoided during testing; instead they provide the information required to statistically assess device longevity under a wide variety of physiological and hyper-physiological test conditions.
5.1.2 Through evaluation of fracture locations, the geometries after fractures, and the use conditions of the device, this guide may be used to help assess device safety.
5.1.3 This guide may be used to help assess differences in fatigue life between different devices or device histories. The effects on fatigue life due to changes to a device’s geometry, processing, or material may be assessed using this guide.
5.1.4 Users of this guide must keep in mind that bench tests are simulations of in-use conditions. Adherence to this guide may not guarantee that results translate to individual clinical scenarios. Therefore, in assessing a device’s fatigue performance, the results from Fatigue to Fracture testing should be reviewed in combination with other available data, such as animal studies, clinical experience, and computational simulations.
5.2 Significance of this Methodology:
5.2.1 While the FtF methodology applies only to bench tests, it can provide insights into device behavior that would not necessarily be apparent in clinical studies that typically focus on patient outcomes. After appropriate boundary conditions such as loadings, fixturing, and materials have been determined, the FtF methodology can provide extensive information on the expected longevity of a device in a period 10 to 1000 times shorter than ...
SCOPE
1.1 This guide is intended to provide an experimental methodology to assess and determine the structural fatigue life of implantable cardiovascular medical devices.
1.2 This guide is also intended to provide methodologies to determine statistical bounds on fatigue life at in vivo use conditions using measured fatigue life derived in whole or in part from hyper-physiological testing to fracture.
1.3 This guide may be used to assess or characterize device durability during design development and for testing to device product specifications.
1.4 Fretting, wear, creep-fatigue, and absorbable materials are outside the scope of this guide, though elements of this guide may be applicable.
1.5 As a guide, this document provides direction but does not recommend a specific course of action. It is intended to increase the awareness of information and approaches. This guide is not a test method. This guide does not establish a standard practice to follow in all cases.
1.6 This guide is meant as a complement to other regulatory and device-specific guidance documents or standards and it does not supersede the recommendations or requirements of such documents.
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
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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: F3211 − 17
Standard Guide for
Fatigue-to-Fracture (FtF) Methodology for Cardiovascular
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Medical Devices
This standard is issued under the fixed designation F3211; 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 2. Referenced Documents
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2.1 ASTM Standards:
1.1 This guide is intended to provide an experimental
methodology to assess and determine the structural fatigue life E178 Practice for Dealing With Outlying Observations
E456 Terminology Relating to Quality and Statistics
of implantable cardiovascular medical devices.
E468 Practice for Presentation of Constant Amplitude Fa-
1.2 This guide is also intended to provide methodologies to
tigue Test Results for Metallic Materials
determine statistical bounds on fatigue life at in vivo use
E739 PracticeforStatisticalAnalysisofLinearorLinearized
conditions using measured fatigue life derived in whole or in
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
part from hyper-physiological testing to fracture.
E1823 TerminologyRelatingtoFatigueandFractureTesting
1.3 This guide may be used to assess or characterize device
F2477 Test Methods forin vitro Pulsatile Durability Testing
durability during design development and for testing to device
of Vascular Stents
product specifications.
F2942 Guide forin vitro Axial, Bending, and Torsional
Durability Testing of Vascular Stents
1.4 Fretting, wear, creep-fatigue, and absorbable materials
F3172 Guide for Design Verification Device Size and
are outside the scope of this guide, though elements of this
Sample Size Selection for Endovascular Devices
guide may be applicable.
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2.2 ISO Standards:
1.5 As a guide, this document provides direction but does
ISO 5840-x Cardiovascular implants -- Cardiac valve pros-
not recommend a specific course of action. It is intended to
theses -- Part 1: General requirements, Part 2: Surgically
increase the awareness of information and approaches. This
implanted heart valve substitutes, Part 3: Heart valve
guide is not a test method. This guide does not establish a
substitutes implanted by transcatheter techniques
standard practice to follow in all cases.
ISO 12107 Metallic materials - Fatigue testing - Statistical
1.6 This guide is meant as a complement to other regulatory
planning and analysis of data
and device-specific guidance documents or standards and it
ISO 25539-x Cardiovascular implants -- Endovascular de-
does not supersede the recommendations or requirements of
vices -- Part 1: Endovascular prostheses, Part 2: Vascular
such documents.
stents, Part 3: Vena cava filters
1.7 This standard does not purport to address all of the
2.3 Regulatory Guidance:
safety concerns, if any, associated with its use. It is the
GuidanceforIndustry:Q9QualityRiskManagement,FDA,
responsibility of the user of this standard to establish appro-
4
2006
priate safety, health and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3. Terminology
1.8 This international standard was developed in accor-
3.1 Definitions of Terms Specific to This Standard:
dance with internationally recognized principles on standard-
3.1.1 acceptance criteria—specific numerical limits or
ization established in the Decision on Principles for the
ranges or other conditions identified prior to testing that
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
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
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This test method is under the jurisdiction ofASTM Committee F04 on Medical the ASTM website.
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and Surgical Materials and Devices and is the direct responsibility of Subcommittee Available from International Organization of Standards, http://www.ISO.org/
F04.30 on Cardiovascular Standards. ISO/store.htm
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Current edition approved Sept. 1, 2017. Published September 2017. DOI: Accessed June 23, 2016 (http://www.fda.gov/downloads/Drugs/./Guidances/
10.1520/F3211-17. ucm073511.pdf).
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F3211 − 17
establish the required results to support a conclusion, a 3.1.8 design l
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