HERNDON, VA — The International Electronics Manufacturing Initiative (iNEMI) is launching a new project to develop testing and use condition guidelines for electronic components used in medical applications. The Medical Components Reliability Specifications Project is the first organized under the consortium’s new Medical TIG (Technology Integration Group).
The project will develop test and extrapolation methodologies to predict reliability of components in actual use. 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 suggest when testing should be done, what kind of testing is required and how to apply test results.
The team’s four areas of concentration are: 1) discretes (e.g. surface-mount
multi-layer chip capacitors, tantalum capacitors, resistors and inductors); 2) array packages (CSP, BGA); 3) substrates and interconnects; and 4) hybrids.
“There are very high expectations for reliability in medical devices, especially implantable devices, and a product’s reliability is significantly affected by the components used in that product,” said Anthony Primavera, Boston Scientific CRM and chair of the Medical TIG. “Drivers such as high quality and reliability, shorter development cycles, a simplified supply chain, extended product lifecycles and increased complexity of medical electronics have resulted in a need for guidelines and specifications for assessing the reliability of electronic components used in medical devices. This project will develop specifications for testing medical electronics and will work with the appropriate standards-making body or bodies to implement those specifications.”
For more info., visit
inemi.org/cms/projects/medical/Medical_Components_Reliability_Specifications.html