ASTM F 3211 : 2017
Current
The latest, up-to-date edition.
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
Hardcopy , PDF
English
01-09-2017
CONTAINED IN VOL. 13.02, 2017 Gives an experimental methodology to assess and determine the structural fatigue life of implantable cardiovascular medical devices.
Committee |
F 04
|
DocumentType |
Guide
|
Pages |
14
|
PublisherName |
American Society for Testing and Materials
|
Status |
Current
|
1.1This guide is intended to provide an experimental methodology to assess and determine the structural fatigue life of implantable cardiovascular medical devices.
1.2This 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.
1.3This guide may be used to assess or characterize device durability during design development and for testing to device product specifications.
1.4Fretting, wear, creep-fatigue, and absorbable materials are outside the scope of this guide, though elements of this guide may be applicable.
1.5As 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.
1.6This 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.
1.7This 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.
1.8This 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.
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ISO 25539-2:2012 | Cardiovascular implants Endovascular devices Part 2: Vascular stents |
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ASTM E 1823 : 2012 : REV : EDT 0 | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 2007 : REV A | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 456 : 2002 | Standard Terminology for Relating to Quality and Statistics |
ASTM F 2477 : 2006 | Standard Test Methods for <bdit>in vitro</bdit> Pulsatile Durability Testing of Vascular Stents |
ASTM F 2477 : 2024 | Standard Test Methods for <emph type="ital"> in vitro</emph> Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
ASTM E 468 : 1990 : R2004 | Standard Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials |
ASTM E 456 : 2013 : REV A : R2022 | Standard Terminology Relating to Quality and Statistics |
ASTM E 1823 : 2009 : REV A | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 456 : 2013 : REV A : R2022 : EDT 1 | Standard Terminology Relating to Quality and Statistics |
ASTM F 3172 : 2015 | Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
ASTM E 178 : 2016 : REV A | Standard Practice for Dealing With Outlying Observations |
ASTM E 1823 : 2024 : REV B | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 456 : 2013 : REV A : R2017 : EDT 5 | Standard Terminology Relating to Quality and Statistics |
ISO 5840-1:2015 | Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
ASTM E 178 : 2021 | Standard Practice for Dealing With Outlying Observations |
ASTM E 739 : 2023 | Standard Guide for Statistical Analysis of Linear or Linearized Stress-Life (<emph type="bdit">S-N</emph>) and Strain-Life (ε-<emph type="bdit" >N</emph>) Fatigue Data (Withdrawn 2024) |
ASTM E 1823 : 2005 : REV A : EDT 1 | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 178 : 2000 | Standard Practice for Dealing With Outlying Observations |
ASTM E 1823 : 2010 : REV A | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 2021 | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 2009 : REV B | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 2013-07 | TERMINOLOGY RELATING TO FATIGUE AND FRACTURE TESTING |
ASTM F 2477 : 2007 | Standard Test Methods for <i>in vitro</i> Pulsatile Durability Testing of Vascular Stents |
ASTM E 178 : 1994 | Standard Practice for Dealing With Outlying Observations |
ASTM E 1823 : 2012 : REV D | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 2012 : REV B | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM F 2477 : 2023 | Standard Test Methods for <emph type="ital"> in vitro</emph> Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
ASTM F 3172 : 2015 : R2021 | Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
ASTM F 2477 : 2007 : R2013 | Standard Test Methods for <emph type="bdit">in vitro</emph> Pulsatile Durability Testing of Vascular Stents |
ASTM E 739 : 2010 : R2015 | Standard Practice for Statistical Analysis of Linear or Linearized Stress-Life (<emph type="bdit">S-N</emph>) and Strain-Life (ε-<emph type="bdit" >N</emph>) Fatigue Data |
ASTM E 1823 : 1996 : R2002 | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 1996 : EDT 1 | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 2012 : REV A | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM F 2942 : 2013 | Standard Guide for <emph type="bdit">in vitro</emph> Axial, Bending, and Torsional Durability Testing of Vascular Stents |
ASTM E 1823 : 2007 | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 468 : 2018 | Standard Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials |
ISO 5840-2:2015 | Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes |
ASTM E 1823 : 2024 : REV C | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 2023 | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 456 : 2013 : REV A : R2017 : EDT 4 | Standard Terminology Relating to Quality and Statistics |
ASTM E 456 : 2013 : REV A : R2017 : EDT 6 | Standard Terminology Relating to Quality and Statistics |
ASTM E 1823 : 2013 | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 2012 : REV C | Standard Terminology Relating to Fatigue and Fracture Testing |
ISO 12107:2012 | Metallic materials — Fatigue testing — Statistical planning and analysis of data |
ASTM E 1823 : 2020 : REV B | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 2005 : REV A | Standard Terminology Relating to Fatigue and Fracture Testing |
ASTM E 1823 : 2011 | Standard Terminology Relating to Fatigue and Fracture Testing |
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