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HERNDON, Va. The International Electronics Manufacturing Initiative (iNEMI) will develop test and usage condition guidelines to assess reliability in medical devices. The Medical Components Reliability Specifications Project, organized by the consortium's Medical Technology Integration Group (TIG), is being presented to the iNEMI technical council today, August 10, 2006.
iNEMI members requested that a project address issues related to medical electronic components for implantable applications, said Jin McElroy, CEO of iNEMI. Drivers such as reliability, development cycles, extended product life cycles, and increasing complexity in medical electronics resulted in the need for guidelines and specifications to assess reliability, explained Anthony Primavera, senior technical advisor, Boston Scientific, and iNEMI Medical TIG chair. The project will define test and extrapolation methodologies for predicting component reliability in a real-use environment. Possible guidelines will cover when to test, what types of tests are required, and how to apply relevant results. An additional consideration is the difference between RoHS-exempt and non-exempt "out of scope" status, noted by Cynthia Williams, director of communications at iNEMI. The Medical TGI members will collaborate with standards-making bodies to implement guidelines in each area.
Three main medical sectors implanted electronics, consumer/portable medical, and large-scale imaging and diagnostics correspond to four areas of concern for iNEMI, including component reliability, lead-free and conversion to RoHS-compliant finishes, circuit board technology, and radio frequency (RF) telemetry and communication. "The Medical TIG decided to address component reliability first due to the immediate impact on patient safety," said Primavera. Discretes, array packages, substrates and interconnects, and hybrids comprise iNEMI's areas of concentration for the Medical TIG plan. Primavera explained that while this first project focuses on components, a second project has been initiated for circuit boards.