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09464 Accelerated Testing of Active Implantable Medical Devices

Picture for 09464 Accelerated Testing of Active Implantable Medical Devices
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Product Number: 51300-09464-SG
ISBN: 09464 2009 CP
Author: Larry Eiselstein, Paul Verghese and Eric P. Guyer
Publication Date: 2009
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Although the intention of most in vitro accelerated tests performed on implantable medical devices is to exacerbate particular failure modes and evaluate the reliability of a device rapidly, these tests often do not yield the same type of failures, if any failures occur at all, as observed in service (i.e., in vivo). Unfortunately, a definitive correlation between in vitro accelerated life testing and in vivo experience can occur only after a device has been implanted in a human. Therefore, developing an appropriate suite of accelerated tests to estimate the service life of active implantable medical devices in vivo requires careful evaluation of the mechanical, environmental, and electrical conditions under which the devices typically operate. In this presentation, we discuss some of the considerations that must be taken into account, including the use of “abuse” tests intended to identify potential in vivo failure modes before accelerated tests are designed.
Although the intention of most in vitro accelerated tests performed on implantable medical devices is to exacerbate particular failure modes and evaluate the reliability of a device rapidly, these tests often do not yield the same type of failures, if any failures occur at all, as observed in service (i.e., in vivo). Unfortunately, a definitive correlation between in vitro accelerated life testing and in vivo experience can occur only after a device has been implanted in a human. Therefore, developing an appropriate suite of accelerated tests to estimate the service life of active implantable medical devices in vivo requires careful evaluation of the mechanical, environmental, and electrical conditions under which the devices typically operate. In this presentation, we discuss some of the considerations that must be taken into account, including the use of “abuse” tests intended to identify potential in vivo failure modes before accelerated tests are designed.
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