The implications of RoHS on active implantable medical devices

This paper discusses the Restriction of Hazardous Substances (RoHS) directive as it relates to active implantable medical devices (AIMD). AIMD have remained out of the scope of RoHS at this time. The changes to large volume commercial electronics targeted by RoHS have resulted in changes to component sourcing that have impacted AIMD components in the availability of non-RoHS legacy components and changes to materials and lead plating. The issues that would need to be addressed if RoHS legislation changes to include AIMD are discussed from a use condition perspective and lessons learned during the commercial change-over to RoHS compliant materials/systems/processes.