Abstract
Implantable medical device (IMD) batteries have very high reliability requirements for materials stability, specifically in terms of corrosion resistance, to assure the performance and reliability of the battery and device and the patient safety. Corrosion assessment and management (CAM) of the battery can be achieved through planning, testing, validation, quality control, and monitoring during the entire lifecycle of the battery product, encompassing research, development, manufacturing, distribution, and implantation with the device. A strategic plan with effective execution of corrosion testing is the key to success. This article presents some basic aspects of IMD battery corrosion assessment and management. The IMD battery chemistry, materials, failure modes, risks and mechanisms of corrosion are reviewed. The processes of corrosion assessment and management in the IMD battery product lifecycle are described. The methods of corrosion testing using electrochemical coupons and battery samples are discussed and highlight detail of corrosion cell design, test conditions and accelerated testing. Some of the technical challenges and outcomes in corrosion assessment of IMD battery are demonstrated through examples. A general strategy for corrosion testing and reliability demonstration is given for consideration.
