Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

050

Date of Entry 09/17/2018 

FR Recognition Number

3-154

Standard

ASTM  F3211-17
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices

Scope/Abstract

This guide is intended to provide an experimental methodology to assess and determine the structural fatigue life of implantable cardiovascular medical devices.

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.

This guide may be used to assess or characterize device durability during design development and for testing to device product specifications.

Fretting, wear, creep-fatigue, and absorbable materials are outside the scope of this guide, though elements of this guide may be applicable.

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.

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.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Finn Donaldson   FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/   301-796-9579   Finn.Donaldson@fda.hhs.gov

Jason Weaver   FDA/OC/CDRH/OSEL/DAM/   301-796-2504   Jason.Weaver@fda.hhs.gov

Samuel Raben   FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/   240-402-6629   Samuel.Raben@fda.hhs.gov

Standards Development Organization

ASTM ASTM International http://www.astm.org/

FDA Specialty Task Group (STG)

Cardiovascular

*These are provided as examples and others may be applicable.