An electrical and biomedical engineering guide to designing wearable medical patches that pass FDA 510(k) and IEC 60601 tests.
Any wearable material in prolonged contact with patient skin must undergo rigorous biocompatibility testing, including cytotoxicity, irritation, and sensitization assays, ruling out allergic reactions over multi-week deployments.
Balancing continuous optical LED pulsing with sub-milliamp battery draw requires aggressive power gating. Microcontrollers sleep between pulse bursts, drawing less than 3 microamps during idle phases.
Wearables must withstand real-world electrostatic discharges (ESD) up to 15 kV and continue operating without corruption in electromagnetic fields generated by home appliances and smartphones.