MEPTEC & IMAPS Semiconductor Speaker Series
"Mil Spec Hermeticity Testing of Class III Medical Implants"
Tom Green - TJ Green Associates
Much of the medical device industry has adopted MIL-STD-883 TM 1014 (Seal) and TM 1018 (Internal Gas Analysis) for use in testing Class III products. This presentation will review some of the challenges and limitations that arise when applying these test methods to medical devices. Mil products are intended to operate over a temp range of -55 C to 125 C and lifetimes of 10 to 30 years vs medical implnts that operate at a steady 37 C and often shorter lifetimes. A review of how to set the hermeticity spec and predicted moisture ingress in vivo will also be discussed and presented.