The iNEMI medical products sector is helping to build the future of medical electronics by working toward understanding the need and requirements of high reliability medical components. Several iNEMI members and suppliers to the industry have teamed up to work toward establishment of standards and recommendations for so called "medical grade" components and circuit boards to be utilized in high reliability applications. Drivers, such as high quality and reliability, shorter development cycles, simplified supply chain, extended product life cycles and increased complexity of active electronic implants, have resulted in a need for non-prescriptive guidelines and standards for assessing the reliability of electronics components used in high end medical applications such as "implantable devices." The goal of the Medical Components Reliability Specifications Initiative is to leverage industry knowledge to create a minimum set of requirements for electronics components for application in life critical applications. This will allow component suppliers access to the entire industry by providing commonly accepted accelerated testing, extrapolation analysis, materials and processes. Medical device manufacturers will achieve proven quality, reliability and consistency from these components.
The overall focus of this group is the establishment of a set of recommendations and standards that the electronics community would embrace for electronic medical products. Emphasis is on high reliability applications such as implanted or life critical devices that simply must always work. To this end, medical applications often require very rigorous testing and validation of components before use. Unfortunately, there are no widely accepted standards or guidelines for the electronic components and circuit board suppliers to follow to production of medical grade units. This results in each end user having his or her own set of requirements for each supplier. A main goal of this effort is therefore aimed at providing clarification and identification of guidelines for the industry's supply chain for medical electronics componentry.
A few examples of what the group considered:
Issues in the transition to lead-free
Discrete component testing
Thermal cycle test requirements
Statistical sample size requirements