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.
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.
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.