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ASTM F 3211 : 2017

Current

Current

The latest, up-to-date edition.

Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-09-2017

€61.92
Excluding VAT

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.

ASTM F 2942 : 2019 Standard Guide for <emph type="bdit">in vitro</emph> Axial, Bending, and Torsional Durability Testing of Vascular Stents

ASTM E 1823 : 2024 Standard Terminology Relating to Fatigue and Fracture Testing
ASTM F 2477 : 2019 Standard Test Methods for <emph type="bdit">in vitro</emph> Pulsatile Durability Testing of Vascular Stents
ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
ASTM E 1823 : 2024 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
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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