The International Electronics Manufacturing Initiative (iNEMI) is launching a new project — the Medical Components Reliability Specifications Project — to develop testing and use condition guidelines to help assure reliability of electronic components used in medical applications.This project is the first organized under the consortium’s new Medical TIG (Technology Integration Group).
“As is happening in so many industries, medical products are increasingly relying on electronics for their functionality. As would be expected, there are unique requirements relating to reliability and operating conditions for components used in these applications,” said Jim McElroy, CEO of iNEMI. “Several of our members told us they would like for iNEMI to address some of the issues related to medical electronic components for implantable applications. In response, we organized the Medical TIG and are developing new collaborative efforts in this area.This new focus has not only helped us respond to members who are active in this market segment, but has also attracted new members from the medical electronics field.”
iNEMI’s Medical Components Reliability Specifications Project will develop test and extrapolation methodologies that can be used to predict reliability of components in actual use conditions. Leveraging industry knowledge and existing standards, the project team plans to create a minimum set of requirements for electronic components used in implanted or life critical devices. The project will also develop guidelines that provide information about when testing should be done, what kind of testing is required, and how to apply test results such that they are relevant to the use conditions developed.
The team has defined four areas of concentration: (1) discretes (e.g., surface mount multi-layer chip capacitors, surface mount tantalum capacitors, surface mount resistors and surface mount inductors); (2) array packages (CSP, BGA); (3) substrates and interconnects; and (4) hybrids.
A few examples of what the group is considering are as follows: issues in the transition to lead free; discrete component testing; thermal cycle test requirements; and statistical sample size requirements.