The goal of this iNEMI Medical TIG Forum was to present to the industry the TIG’s process for the establishment of a minimum set of requirements for electronics components for application in life critical applications developed in the TIG’s Medical Component Reliability Project Review Project.  In addition, there was a review of the TIG’s validation process, demonstrated in the Medical Reliability for MLCC Project, which is determining accelerated life test methods of long-term leakage and breakdown failures of Multi-Layer Chip Capacitors (MLCC).

NOTE:  All presentations are downloadable PDFs

Agenda

FDA Introduction
William Regnault, FDA

iNEMI Overview
Chuck Richardson, iNEMI

Medical Components Reliability Specifications Meeting – MLCC Phase I Wrap Up and Phase II Introduction
Anthony Primavera, Boston Scientific CRM

Medical Substrates - Phase 1 Discussion
Thomas Jacob, Dyconex

Role of Standards in the Assessment of Medical Devices
Victoria Wagman, FDA

Reliability of Flexible Termination Ceramic Capacitors in Temperature-Humidity-Bias Conditions
Michael H. Azarian, Center for Advanced Life Cycle Engineering (CALCE), University of Maryland