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The Biocompatibility and Biostability of New Cardiovascular Materials and Devices

  • Ken Stokes
Chapter
Part of the Biological and Medical Physics, Biomedical Engineering book series (BIOMEDICAL)

Abstract

Evaluating a new material for use in an implantable device is a complicated business. ISO 14971 is designed to assist in determining device-risk assessment. ISO 10993 is intended to help steer one through the evaluation of materials for implantable devices. An FDA Guidance is available specifically for pacemaker leads, but may be helpful for other devices as well. However, completing a battery of in vitro and in vivo tests does not necessarily qualify a material for implant, because the in vivo environment cannot be duplicated in vitro. In vivo materials testing helps, but is still insufficient because the device may have its own issues. Device implants in animals may get one to human clinical studies and market release. Even after this stage, appropriate postmarket surveillance is necessary to know for sure how the device is really performing.

Keywords

Implantable Device Potential Harmful Effect Pacemaker Lead Biocompatibility Testing Market Release 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Brady Leads Research, Cardiac Rhythm Disease Management DivisionMedtronic, Inc.BrainerdUSA

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