Forum on Component Reliability for Medical Electronics Announced

The International Electronics Manufacturing Initiative (iNEMI) is holding a medical electronics forum to discuss requirements and recommendations developed for the electronics industry to ensure reliability of components used in medical products. The event is scheduled for 14 November and will be hosted by US FDA at its White Oak campus in Silver Spring, MD.

“Life-critical medical products, particularly implantable devices, require a high level of reliability, which means that medical applications often require rigorous testing,” says Anthony Primavera, Fellow R&D, PG Process Development, Boston Scientific-CRM, and chair of the the iNEMI Technology Integration Group (TIG). “The performance requirements for electronic components used in a pacemaker, for example, are much more stringent than those used in an MP3 player. However, there are currently no widely accepted guidelines for the electronics component and circuit board suppliers to follow for production of medical grade units. Instead, each medical device manufacturer has its own set of requirements that suppliers must meet,” notes Primavera.

For two years, iNEMI’s Medical TIG has been working to identify and clarify guidelines for the supply chain for medical electronic components. The upcoing forum will report on the organization’s work to date. It will also serve as a sounding board to get industry feedback and begin building industry support for wide adoption of the recommended guidelines and methodologies, according to Primavera.

The first phase of iNEMI’s Medical Components Reliability Specifications Project defined a set of requirements for life-critical medical components based on use conditions and supplier risks. The team developed test and extrapolation methodologies, specifically focusing on surface mount multilayer chip capacitors (MLCCs). Work is currently underway to validate these requirements against accelerated test methodologies established in Phase II of the project.

“The iNEMI guidelines are intended to encompass many different components, including boards, resistors, ICs and more. Our initial evaluation, however, is being done with capacitors,” explains Primavera. “This same process must be followed for other types of components, and we hope this forum will give us the opportunity to identify additional industry collaborations to validate requirements for other components.”

Forum topics will include:

• Existing and related standards and test methods
• Use conditions for life-critical medical components
• Test and extrapolation methodologies
• Medical grade guidelines
• Failure modes and effects analysis of MLCC failures
• Accelerated life test methods to determine long-term leakage and breakdown failures of MLCCs

The forum is scheduled for 14 November from 9:30 to 15:30 at the US FDA White Oak Campus, 10903 New Hampshire Avenue, Building 2, Room F2047E, Silver Spring, MD, USA. There is no registration fee; however, registration is required by 31 October for security reasons. US citizens can register online; foreign attendees must download and complete this form.