Risk Management of Class 3 Electronics as a Function of Cleanliness

In mission-critical Class 3 electronics, reliability is non-negotiable. Failures caused by residues trapped under leadless components can lead to leakage currents, dendritic growth, and catastrophic performance loss. This paper applies a risk management framework to contamination, demonstrating how design, solder materials, reflow, and cleaning processes impact electrochemical reliability. Through Surface Insulation Resistance (SIR) testing, ion chromatography, and statistical modeling, the study identifies the most influential factors—cleaning method, component type, standoff gap, and flux residue. Results show that inline cleaning processes and optimized design features significantly reduce contamination risks, ensuring safer and more reliable Class 3 assemblies. By combining failure mode analysis with advanced testing, manufacturers gain actionable insights to control contamination, mitigate risk, and enhance long-term product performance in demanding environments.