A French manufacturer of patient monitors faced a critical hurdle.
Their new multi-parameter monitor needed to meet IEC 60601-1 Edition 3.1 — specifically the patient leakage current limit of 10 microamps for applied parts.
Their previous power supply vendor couldn't guarantee that level consistently across production batches. Units varied from 8µA to 28µA — a huge risk for a Class II medical device.
We assigned a dedicated medical compliance engineer to work with their team. This was not a generic support call — it was a focused engineering engagement from day one.
Redesign #1: We redesigned the flyback transformer with reinforced insulation and triple-wound shielding to reduce capacitive coupling between primary and secondary.
Redesign #2: We selected a medical-grade Y-capacitor with tighter tolerance, further stabilizing leakage current across frequency and temperature variations.
After three prototype iterations, we put the design to the test.
200 samples measured.
Consistent leakage current below 8 µA.
Full margin against the 10µA limit.
They passed certification on the first submission.
Their regulatory affairs manager said:
"You turned our biggest risk into a non-issue."
Medical power is not about meeting the spec. It is about having margin you can prove.
When lives depend on your equipment, "good enough" is not acceptable. You need a partner who understands the physics, the regulations, and the margin required to sleep well at night.
Choose KRECO. Where risk becomes non-issue.
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